Oviya MedSafe - A Decade Of Journey

Page 1

ISSUE

Dr J Vijay Venkatraman

Newsletters

In the News

Articles

10 YEARS

Oviya MedSafe – A Decade of Journey

Interviews


Foreword

Dr J Vijay Venkatraman, the name does not

need

an

introduction

in

the

Realm

of

Pharmacovigilance. A man whose relentless passion in this niche domain is known to the entrants in this field, the

Brief CV

Health Care Practitioners, the Pharma People, the founders of various organizations; the CEOs, and the veterans in the global industry. This was not easy for him

Detailed Professional Profile

to earn this swiftly. He is here now because of his undying pursuit of the fruition of his dream.

Monthly Newsletters

News

Interviews

Articles

I started observing him closely to understand the domain (which was new to me). His passion towards Pharmacovigilance and his (dear child) organization Oviya MedSafe did not diminish; rather, it proliferated. His dream of making the common man known about Pharmacovigilance can be vividly seen in his writings. His intrinsic nature of how to attract the common to his thoughts is profoundly appreciable.

Certificate

DIA

Publication in Chinese Language

Speaking at Lords in the UK Parliament

In this book, I tried collating all the newsletters he penned, the interviews he responded to, the Articles written for the peers, his involvement in the DIA., etc. I seek apology for not including his speeches at various Conferences across the globe in this book, but able to showcase his participation through the Certificates he received. No one would hesitate to state that the learning will be greater if one acquaints himself with. He

Dr Vijay’s Abode

Glossary

never failed to appreciate those who supported him. His writings manifest it to his readers. Sincere wishes for him to continue his journey

By KarthikaPandi Jeyachandran A Proud Oviya MedSafe-ian


Dr J Vijay Venkatraman MBBS, F. Diab., MBA, FPIPA (UK)

Brief Professional Profile Dr J Vijay Venkatraman is a Diabetologist, Drug Safety Physician and an Entrepreneur, with 20 + years of combined professional experience in Clinical Medicine & Drug Safety. He holds a MBA degree in Services Management. He is the first Indian to have been conferred the Fellowship of the Pharmaceutical Information & Pharmacovigilance Association (PIPA), United Kingdom. Dr Vijay founded Oviya MedSafe, a Pharmacovigilance Consulting & Services Company based out of Coimbatore, India in 2012 and London, UK in 2014 which has been catering to the international as well as the Indian pharmaceutical industry ever since its inception. Dr Vijay has held the honorary position ‘Regional Editor, India’ of Global Forum, the official magazine of the Drug Information Association (DIA) since April 2017. Dr Vijay is an Executive Committee Member of the Indian Society for Clinical Research (ISCR) from 2013. He is also one of the key members of the Pharmacovigilance Working Group of ISCR. He was the former Chair (First Chairperson) of the Pharmacovigilance Council of the Indian Society for Clinical Research. Dr Vijay is the former Chairman of IMA-HQ Standing Committee for Pharmacovigilance. He also served as the Chairman of the Pharmacovigilance Standing Committee of the Indian Medical Association – Tamil Nadu State Branch, for the years 2018 and 2019. Dr Vijay is an Affiliate Member of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom and an Associate Member of the Pharmaceutical Information & Pharmacovigilance Association, United Kingdom. Dr Vijay is an invited speaker and chairperson in national and international conferences on Drug Safety as well as Diabetology. He has numerous publications to his credit and his publications came in many national and international journals and magazines. He is a member of several professional associations and is actively involved in promoting pharmacovigilance awareness among all stakeholders of the discipline. Dr Vijay is a recipient of many awards including the ‘Leadership Excellence Award’ and the ‘State Appreciation Award for Co-ordinating Academic Activities’ by the Indian Medical Association. Dr Vijay has been associated with various institutes as a Pharmacovigilance Trainer. He is also a practising Diabetologist at Diabat-ease Clinik, KTVR Group Hospital, Coimbatore.

**********


Detailed Professional Profile

1 of 328


Awards Received from Indian Medical Association (IMA) Sl No

Details of the awarding office

1

IMA Coimbatore Branch

Leadership Excellence Award (Awarded during Doctor’s Day celebration in 2016)

2

IMA Tamil Nadu State Branch

State President Appreciation Award for Face book Communication (Awarded during IMA Tamil Nadu State Conference in 2013)

3

IMA Coimbatore Branch

Appreciation Award (Received from the Worshipful Mayor of Coimbatore Mr S M Veluswamy during installation of new officebearers of IMA Coimbatore on 25th Dec 2011)

4

IMA Tamil Nadu State Branch

State Secretary Appreciation Award for Co-coordinating Academic Activities (Awarded during IMA Tamil Nadu State Conference in 2011)

Details of the awards

Medical Text books Authored/Co-authored SNo 1

Details of the Medical Text Books

Details of the Topics/ Chapters

Special Issues in Pharmacovigilance in Resource- Limited Countries

“Pharmacovigilance Challenges”

Situation

in

India

-

Issues

and

(To be published by Springer International Publishing AG, Switzerland)

(This book is edited by renowned US-based Drug Safety Physician & Scientist Dr Syed Ahmed, who invited me to write this chapter focusing on the Indian Pharmacovigilance scenario)

2 of 328


Interviews SNo 1

Details of the Publication DIA: Audio Interview

Title of the Interview New Ethics and Consent Guidelines: Pillars for Safety in India

Sep 13, 2019 2

Express Pharma, July 16-31, 2019

3

News Today, Aug 30, 2018

4

Pharmabiz, Jun 21, 2018

5

6

Drug Information Association,

Gap analysis of pharmacovigilance

some

key

stakeholders

of

Indian

Keep an eye on Indian drugs to prevent rare side-effects: Pharmacovigilance expert Pharmacovigilance guidance document should be made part of D&C Act to ensure 100% compliance of drug industry: Expert PvPI: Technology meets Opportunity to improve Safety

Mar 20, 2018

(Audio Interview by Dr Alberto Grignolo, Editor-in-Chief, DIA Global Forum, available online as podcast)

Express Pharma,

Key to Quality

Nov 20, 2017 7

New Today,

TN Doctor to speak in UK Parliament

Oct 26, 2015 8

The Wall Street Journal,

New Outsourcing Frontier in India: Monitoring Drug Safety

Feb 1, 2015 9

Express Pharma,

Pharmacovigilance: The way forward for India

Aug 15, 2013 10

Pharma Bio World,

Thalidomide Tragedy Revisited

Sep, 2013 3 of 328


Papers published in indexed Journals SNo

Details of the Journals

Details of the papers published

1

Journal of Young Pharmacists , April 2016

Pharmacovigilante’s in the Pharmacovigilance Programme of India: Ideal Qualities & Skills

2

Indian Journal of Pharmacist as Pharmacovigilance Practitioner Pharmacy Practice, March 2015

3

Journal of PIPA-PIPELINE , September 2014 (UK Journal)

The Role of Clinical Pharmacists in Pharmacovigilance : Some thoughts from India

4

Journal of Association of Physicians of India , December 2012

Eight Cases of Bladder Cancer in Pioglitazone users from India

5

Indian Journal of Clinical Medicine, November 2012

Need to Increase Awareness among Urologists regarding the Possible Association between Pioglitazone and Bladder

6

Journal of Diabetes, Science & Technology , January 2010

Epidemiology of Cardiovascular Disease in Type 2 Diabetes: The Indian Scenario

7

Journal of Association of Physicians of India , June 2008

Challenges in Diabetes Care in India: Sheer Numbers, Lack of Awareness and Inadequate Control

Cancer

4 of 328


Publication in Magazines SNo 1

Name of the Publication Pharma Bio World, Jul, 2021

Details of the Articles Pharmacovigilance as an Indispensable Ingredient for India’s Pharma Growth Formula

2

DIA Global Forum,

Data Handling and Reporting for Ongoing Clinical Trials During COVID-19

3

DIA Global Forum,

Pharmacovigilance and Risk Management Strategies in Asia 2020

Mar 9, 2020 4

DIA Global Forum,

New Pharmacovigilance Obligations for MAHs in India

Jan 1, 2018 5

DIA Global Forum,

Pharmacovigilance Programme of India: SWOT Analysis

Feb 1, 2017 6

Express Pharma, Nov 20, 2016

7

The Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom,

Pharmacovigilance as a Value Addition for the Pharma Industry Pharmacovigilance in India – The Past, Present and Future

Mar 30, 2016 8

Pharma Times, Aug 2015

9

Chronicle Pharmabiz,

Social Media as a Catalyst in the Advancement of Pharmacovigilance Current Status of Pharmacovigilance in India

Apr 2, 2015 5 of 328


10

Pharmaphorum, Aug 12, 2014

11

Pharma Bio World, Feb, 2014

12

Pharma Bio World, Apr, 2013

13

Pharma Bio World,

Incretin-based anti-diabetic therapies: a pharmacovigilance perspective Gearing up for a Pharmacovigilance Audit Using a Risk Based Approach Pharmacovigilance Outsourcing and Career Advantages for Indian Professionals Pharmacovigilance in India – A Perspective

Mar, 2013

Lectures/ Presenting papers/ Chairing Scientific Sessions in State/ National/ International Medical Conferences SNo 1

2

Details of the Conferences

Details of the Topics (please state presented/ lecture/chaired etc)

Half-day workshop on Good Clinical Practice and Regulatory Updates in Clinical Trials

'SAEs in Clinical Trials – Causality assessment and Ongoing Product Risk versus Benefit assessment'

20th November 2021

(Speaker)

19th Skill Development Programme on Medical Products organized by National Coordination Centre (NCC), Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC)

Role of Healthcare Professionals in Pharmacovigilance on 11th November 2021

8th - 12th November 2021

(Speaker)

6 of 328


3

DIA India 8th Annual Pharmacovigilance Conference

Interpreting Indian Pharmacovigilance Regulations & 2018 Guidelines

21st & 22nd October 2021 4

5

6

Indian Medical Association (IMA)

Panel Discussion : Working Together in Pharmacovigilance for Patient Safety

22nd September 2021

(Moderator)

Sri Ramakrishna Institute of Paramedical Sciences, Coimbatore

Life with Pharmacovigilance

20th September 2021

(Speaker)

Association of Community Pharmacists of India (ACPI) & CliMed Research Solutions

Post-Marketing Pharmacovigilance Activities: An Overview on 17th September 2021

16th - 17th September 2021 7

Regional Training Center, Department of Clinical Pharmacology & Therapeutics, NIMS Hyderabad

(Speaker) Training on Signal Detection and Assessment in Pharmacovigilance

(Speaker)

rd

3 September 2021 8

International Pharmacovigilance (PhV) Days 2021

GVP-like legislation outside Europe: overlap and differences on 15th June 2021 (Speaker)

14th - 18th June 2021 9

ISCR : 14th Annual Delivered a talk at the Pre-conference Workshop Conference: Clinical Research “Authoring a Robust Pharmacovigilance System Master – Transforming Lives : 2021 File (PSMF/PVMF)” on 13th March 2021. and Beyond 19th & 20th March 2021 7 of 328


10

ISCR : 7th Annual Pharmacovigilance Symposium

Panel Discussion : Connecting the Dots in the ADR Reporting Value Chain

Pharmacovigilance 2020 Adapting To New Age Patient Safety! (Moderator) rd

th

3 & 4 December 2020 11

ISCR: Clinical Research Landscape – Post 2020

Pharmacovigilance & Real World Evidence : Introduction and Context Setting

9th & 10th October 2020 12

ISCR: Pharmacovigilance Awareness Campaign 18th July 2020

13

ISCR : Importance of pharmacovigilance and clinical research for community and hospital pharmacists,academicians, researchers and students. 23rd May 2020

14

(Chairperson) Role of Community Pharmacists and Hospital Pharmacists in Pharmacovigilance

(Speaker)

PIPA : Pharmacovigilance and Medical Information Webinar 9th and 10th March 2020

15

DIA : Pharmacovigilance and Risk Management Strategies Conference 27th - 29th January 2020, Washinton, DC

Post-Approval Pharmacovigilance Obligations for the Industry in India: Current Scenario

(Speaker)

8 of 328


16

ISCR : 13th Annual Conference: Beyond New Regulations - Increasing Participation and Enhancing Patient’s Safety

Delivered a talk at the Pre-conference Workshop “Pharmacovigilance Audits and Inspections: Pre Inspection readiness & effective Corrective And Preventive Action implementation” on 23rd January 2020

24th - 25th January 2020, Mumbai 17

ISCR : 6th Annual Pharmacovigilance Symposium 22nd November 2019,

Panel Discussion: Empowering Patients for Comprehensive Drug Safety

(Moderator)

New Delhi

18

19

ISCR : Regulations, Good Clinical Practice and Recent Developments in Clinical Trials

Ongoing Safety evaluation of New Drug Products (Clinical Trials to Post-marketing)

10th November 2019, Coimbatore

(Speaker)

Current Scenario of Patient Safety Vigilance Activities in India

Spoke on the topic ‘Pharmacovigilance in India :A 360 degree view‘

3rd September 2019, Coimbatore 20

Indian Pharmacovigilance Day 2019 Conference 26th July 2019, Mumbai

21

(Speaker) Theme: ‘Hot Topics in Pharmacovigilance 2019’

(Conference Chair)

Vydehi Institute of Medical Sciences & Research Centre

“The Role of Pharmaceutical Industry in bringing about Translational Pharmacovigilance”

19th July 2019, Bengaluru

(Speaker)

9 of 328


22

23

International Pharmacovigilance Day 2019 : Pharmacovigilance within and without borders

Spoke on the topic ‘Pharmacovigilance in India – A Success Story‘

12th & 13th June 2019, Barcelona, Spain

(Speaker)

DIA India 7th Pharmacovigilance Conference

Transforming Clinical Safety and Pharmacovigilance

5th & 6th April 2019, Mumbai 24

25

(Program Committee Member)

Indian Pharmaceutical Association (IPA)

Spoke on the topic : 'Pharmacovigilance in the Indian Pharma Industry'

27th March 2019, Chennai

(Speaker)

Pharma Knowledge and Training Institute a finishing school functioning under the aegis of Tamil Nadu Pharmaceutical Sciences Welfare Trust (TNPSWT)

Invited as a honorary trainer for the Pharmacovigilance Training Programme

(Trainer)

February 2019, Chennai 26

ISCR : 12th Annual Conference : How the New Pharmacovigilance Obligations for MAHs in India may be fulfilled

Delivered a talk at the Pre-conference Workshop “Pharmacovigilance in India - An Industry Perspective” on 14th February 2019.

15th & 16th February 2019, New Delhi 27

1st Entrepreneur Development programme on Pharmacopoeial & Pharmacovigilance Services

Spoke on the title: ‘Sharing Experience in Pharmacovigilance Sector’ (Speaker)

16th November 2018, Ghaziabad 10 of 328


28

Clinical Research in EuropeWhat you need to know to successfully enter the EU market

Spoke on the Module Drug Safety and Pharmacovigilance in the topic ‘Product Safety Monitoring in Europe After Approval’ (Co-organizer/Speaker)

th

15 November 2018, New Delhi 29

30

Indian Society for Clinical Research (ISCR) in collaboration with Coimbatore Respiratory Society (CRS)

Part of the Panel Discussion: Regulations in India and also spoke on the title: ‘ISCR-Overview and Recent Achievements’

14th October 2018, Coimbatore

(Speaker & Panelist)

KRUPACON PHARMA 2018:International Conference on Drug Development and Clinical Research : Current Scenario & Opportunities

Resource person and delivered a talk titled: ‘Monitoring Product Safety beyond Clinical Trials – Industry Practices’

12th & 13th October 2018, Bengaluru 31

KRUPACON 2018:International Conference on Management 4.0 – Disruptions in Business and Millennials at the Workplace 12th & 13th October 2018, Bengaluru

32

TAPPCON 2018 8th & 9th September 2018, Coimbatore

(Speaker)

Spoke on the topic: ‘Operational Disruptions in the Knowledge Industry’

(Speaker) Fourth Tamilnadu & Puducherry State Conference on Pulmonary Diseases (Faculty / Speaker)

11 of 328


33

Indian Pharmacovigilance Day 2018 Conference 27th July 2018, Mumbai

34

IndUS Drug Safety

29th June 2018, Mumbai 35

OPPI Medical Forum 3rd May 2018, Mumbai

36

37

Theme: ‘Hot Topics in Pharmacovigilance 2018’

(Conference Chair) Was the Chief Trainer at the One Day Intensive Training Workshop for Pharmacovigilance Officers Incharge (PvOI) & for the representatives of US FDA ANDA Holders, conducted by Oviya MedSafe for delegates from the pharmaceutical industry. (Organizer & Chief Trainer) Pharmacovigilance Guidance Document for MAHs of Pharmaceutical Products: Impacts on Indian Pharma Companies and Pharmacovigilance Service-Providers

(OPPI = Organisation of Pharmaceutical Producers of India)

(Speaker & Panelist)

DIA India 6th Pharmacovigilance Conference

Theme: ‘Drug Safety Unplugged‘

22nd & 23rd March 2018, Mumbai (DIA = Drug Information Association) ISCR 11th Annual Conference: Collaborative Clinical Research for better Patient Outcomes 19th & 20th Bengaluru

Chair of Session 4 on Day 2

(Session Chair & Program Committee Member) Delivered a talk at the Pre-conference Workshop “Pharmacovigilance: Audits and Inspections” on 18th January 2018.

January 2018, (Scientific Committee Member of the Conference)

(ISCR = Indian Society for Clinical Research)

38

Oviya MedSafe’s Was the Chief Trainer at the One Day Intensive Training & Pharmacovigilance Workshop Certification Workshop for Pharmacovigilance Officers Incharge (PvOI), conducted by Oviya MedSafe for 12 of 328


delegates from the pharmaceutical industry.

39

40

12th January 2018, Mumbai

(Organizer and Chief Trainer)

ISCR 4th Annual Pharmacovigilance Symposium

Theme: ‘Enhancing Pharmacovigilance Excellence in India : An Integrated Approach’

28th October 2017, Hyderabad

(Chair of Organising Committee)

Indian Pharmacovigilance Day 2017 Conference

Theme: ‘Hot Topics in Pharmacovigilance 2017’

28th July 2017, Hyderabad 41

42

43

44

UK Pharmacovigilance Day 2017 Conference

(Conference Chair) Spoke on ‘Pharmacovigilance as a Value Addition to the Global Pharma Industry’

6th June 2017, London

(Conference Chair & Speaker)

DIA India 5th Pharmacovigilance Conference: PV Fast Forward-Technology, Pace, Priority

Spoke on the topic ‘Indian Pharmacovigilance – Where do we stand today?’

24th & 25th March 2017, Mumbai

(Speaker & Program Committee Member)

Drug Diligence 2017

A National Conference & Workshop on Pharmacovigilance

17th & 18th March 2017, Coimbatore

(Chairperson & National Faculty)

ISPOR : Fifth National Conference of Pharmacoeconomics and

Spoke on the topic ‘The Role of Pharmacovigilance in Pharmacoeconomics’

13 of 328


Outcomes Research 3rd & 4th March 2017, New Delhi

(Chairperson & Guest Speaker)

(ISPOR=International Society for Pharmacoeconomics and Outcomes Research)

45

ISCR 3rd Annual Spoke on the topic ‘Pharmacovigilance as a Value Pharmacovigilance Addition for the Pharmaceutical Industry in Symposium: Evolving a Contemporary Indian Scenario’ Pharmacovigilant Environment in India Collaborations, Opportunities & Challenges (Chair of Organizing Committee & Speaker) 24th September 2016, New Delhi

46

Indian Pharmacovigilance Day 2016 Conference

29th July 2016, Mumbai 47

UK Pharmacovigilance Day 2016 Conference

Moderated a colloquium on the Pharmacovigilance Programme of India, with insights from different stakeholders (Conference Chair)

Theme: ‘Hot Topics in Pharmacovigilance 2016’

18th October 2016, London (Conference Chair) 48

DIA India 4th Pharmacovigilance Conference : Innovations In Pharmacovigilance – the era of e-PV 13th & 14th May 2016, Mumbai

Moderated a Panel Discussion titled ‘Destination India – Pharmacovigilance Outsourcing’

(Moderator & Program Committee Member)

14 of 328


49

Pharmacovigilance Programme of India: Performance Appraisal and Way Ahead

Invited by Govt of India to felicitate IPC for its 5th Anniversary as the National Coordination Centre of PvPI

14th April 2016, New Delhi 50

ISCR : 9th Annual Conference 8th & 9th January 2016, Mumbai

51

67th Indian Pharmaceutical Congress 20th December 2015, Mysuru

52

53

Theme: ‘Clinical Research India-Patients First & Research for India’ (Scientific Committee Member)

Specially Invited by Drug Regulatory Authorities to present at the Round Table Meeting for Stakeholders of the Pharmacovigilance Programme of India.

UK South India Business Meet 2015 conducted by BSICC

Spoke on the topic ‘South India – an Attractive and Emerging Global Pharmaceutical Hub’

5th November 2015, London

(Speaker)

6th Annual Pharmacovigilance Asia 2015 Conference

th

th

17 – 20 November 2015, Singapore

Event organized by British South India Council of Commerce (BSICC) at British Parliament, London

Spoke on ‘Exploiting Social Media to identify potential safety signals and to augment adverse event data collection

Panelist in the session ‘Safely Outsourcing Pharmacovigilance Activities to Contract Research Organizations in Asia

Conducted a post-conference workshop ‘Case Narrative Writing for Reporting Adverse Events’

(Speaker, Panelist & Trainer) 15 of 328


54

55

UK Pharmacovigilance Day 2015 Conference

Moderated the Panel Discussion ‘Pharmacovigilance Outsourcing Trends, Predictions and Advantages - A SWOT Analysis’

19th October 2015, London

(Moderator & Conference Chair)

ISCR 2nd Annual Pharmacovigilance Symposium: Leveraging India’s Potential for the Advancement of Global Drug Safety

Spoke on the topic ‘Role of Professional Bodies in Promoting Pharmacovigilance in India’

25th September 2015, Bengaluru

56

International Conference on Roles and Responsibilities of Pharmacist on Chronic Disease Management, Adverse Drug Reaction and Therapeutic Drug Monitoring

(Chair of Organizing Committee & Speaker)

Spoke on ‘Pharmacovigilance as a Career for Pharmacists’ and participated in the panel discussion that followed

25th April 2015, Coimbatore (Speaker & Panelist) 57

ISCR Pharmacovigilance Working Group Symposium

Theme: ‘Comprehensive Pharmacovigilance for India – The Road Ahead’

20th December 2014, Mumbai

Panelist in Session 9 ‘The emergence and promise of pharmacovigilance as an outsourced industry in India’ (Chair of Organizing Committee & Panelist)

58

3rd International Conference and Exhibition on Biowaivers, Biologics and Biosimilars th

Spoke on ‘Pharmacovigilance on Biosimilars: Challenges and Possible Solutions’

Chair of Tracks 4, 5, 10 & 11

29 October 2014, 16 of 328


59

60

Hyderabad

(Speaker & Track Chair)

3rd International Conference and Exhibition on Pharmacovigilance & Clinical Trials

Delivered keynote address on ‘Hosted Pharmacovigilance Software Databases – The Emerging Solution

27th October 2014, Hyderabad

(Dignitary for Inaugural Function & Keynote Speaker)

Pharmacovigilance CME for Practising Doctors

Organized the first of its kind collaborative event between Indian Pharmacopoeia Commission (the National Coordination Centre for the Pharmacovigilance Programme of India) and the Indian Medical Association Tamil Nadu State Branch, to promote awareness of pharmacovigilance among Medical Practitioners.

22nd February 2014, Chennai

61

7th Annual Conference of ISCR

Local Organizing Committee Member

10th & 11th January 2014, Bengaluru 62

IPSCON 2013 - 46th Annual Conference of Indian Pharmacological Society – International Conference on Translational Pharmacology

Faculty for Symposium on Medication Safety

18th Dec 2013, Bangalore (Faculty) 63

BIOYANTRA 2013 - a National Symposium on Medical Devices organized by & at the Department of Biomedical Engineering, SRM University, Chennai

Spoke on the topic ‘Global Safety Regulations for Medical Devices’

6th – 7th September 2013 (Speaker) 64

Tamil Nadu State CRRI CON 2013

Panelist in the session ‘The Road Not Taken’ – Spoke about Careers in Pharmacovigilance for Doctors. The event was a state level career guidance workshop for 17 of 328


young doctors, organized by IMA Coimbatore Branch.

65

25th August 2013, Coimbatore

(Speaker & Panelist)

National Training Workshop on ‘Secured Medicines & Robust Pharmacovigilance Key to Patient Safety & Health’

Spoke on the topic ‘Adverse Drug Reaction (ADR) monitoring system its status, awareness, implementation and reach’

23rd August 2013, Bengaluru

(Organized by Partnership for Safe Medicines (PSM) India Initiative and Grahak Shakti in technical Collaboration with the Indian Pharmacopoeia Commission, Ghaziabad) (Trainer)

66

Fundamentals of Drug Development for Pharmacology & Pharmacy Students 17th August 2013, Chennai

67

National Level Seminar on 'Widening the Horizons for Practising Pharmacists in Industries & Hospitals', organized by & at the Department of Pharmacy Practice of PSG College of Pharmacy 5th July 2013, Coimbatore

68

69

MEDITEX 2012 - the 67th Annual State Conference of the Indian Medical Association (Tamil Nadu State Branch)

Spoke on "Phase IV Trials and Ongoing Drug Safety Management" (Organized by the Department of Pharmacology, Madras Medical College in collaboration with ISCR) (Co-Organizer & Speaker) Spoke on 'Employment Opportunities in Pharmacovigilance for Indian Professionals'

Judged posters presented by Pharmacy students

(Speaker & Judge) Spoke on ‘Pharmacovigilance – An Emerging Medical Specialty’

16th December 2012, Coimbatore

(Speaker)

IMA NATCON 2011 – the 86th National Conference of the

Presented a Free Paper on ‘Pharmacovigilance in India – The Role of Practising Doctors 18 of 328


Indian Medical Association 28th December 2011, Bengaluru 70

GPCON 2011: National Conference of IMA CGP & 2nd International Congress of Family Doctors 29th – 30th October 2011, Chennai

71

TIMA Research Day

(Speaker) Participated in the ‘Skills Workshops’ as Faculty

(Organized by IMA College of General Practitioners) (Faculty)

Was the key person representing Cliniminds and facilitated faculties for the event. Was awarded by IMA TNSB for the successful event. (Organized by IMA TNSB in association with Cliniminds)

th

72

16 October 2011, Erode

(Co-Organizer & Facilitator)

International Congress on Family Medicine

Spoke on ‘Opportunities in Clinical Research – New Scope’ (Organized by IMA College of General Practitioners HQ)

th

27 November 2010, Chennai 73

74

(Speaker)

ERO DIAMOND 2010: 64th Tamil Nadu State IMA Medical Conference

Spoke on ‘Why Should Drug Adverse Events be Reported?

24th April 2010, Erode

(Speaker)

TRAC 2010: 1st Tamil Nadu RSSDI Annual Conference 2010

Spoke on ‘Why Should Drug Adverse Events be Reported?

(Speaker) 18th April 2010, Madurai

19 of 328


Students Classes/ Lectures/ CME/ in Local Academic Forums SNo

Details of the Meeting

Details of the Topics

1

Delivered a guest lecture for Biotechnology students of KSG College of Arts and Science, Coimbatore - 3rd July 2019

'An overview of Pharmacovigilance and its relevance to Life Science Professionals'

2

Lecture for DM (Clinical Pharmacology) students of King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College, Mumbai – 2nd May 2018

‘Life with Pharmacovigilance’

3

Lecture for 2nd MBBS students of Karpagam Faculty of Medical Sciences and Research, Coimbatore – 21st Feb 2018

'Evolution of Pharmacovigilance Multidisciplinary Medical Specialty'

4

Faculty for short term certificate course conducted by Dr.Bhanuben Nanavati College of Pharmacy, Mumbai in association with ISCR – 2nd Dec 2017

Certificate Course on ‘Essentials in Pharmacovigilance’. Delivered the following topics:

as

a

History, general overview of pharmacovigilance and key terminologies

Introduction to Adverse Drug Reactions

5

Lecture for Pharmacy Students of Anurag Group of Institutions , Hyderabad – 15th Sep 2017

‘Life with Pharmacovigilance’

6

Lecture for Biotechnology Students of Kumaraguru College of Technology, Coimbatore - 29th Sep 2016

‘An overview of Pharmacovigilance and its relevance to Life Science professionals’

7

CME on ‘Best Practices in Spoke on the following topics: Pharmacovigilance for Healthcare  Overview of pharmacovigilance – Global Professionals in Contemporary Indian th and Indian Perspective Scenario’ – 12 Aug 2016 Organized by ISCR, IPC & The Dept of Pharmacology, Coimbatore Medical

Pharmacovigilance as a career path for Healthcare Professionals 20 of 328


College, at Coimbatore. 8

Lecture for PharmD Students of RVS ‘Life with Pharmacovigilance’ College of Pharmaceutical Sciences, Coimbatore – 26th Feb 2016

9

One Day Workshop on Narrative Writing in Pharmacovigilance – 10th Jan 2016, Bengaluru

‘Why , What and When of Narratives’

Organized by Oviya MedSafe 10

Seminar on ‘Best Practices in Spoke on the topic: ‘Steps taken by Govt of India Pharmacovigilance for Healthcare to promote Pharmacovigilance’ Professionals in Contemporary Indian Scenario’ – 29th Jul 2015 Organized by ISCR in association with Apollo Research and Innovations, Chennai

11

Lecture for Students of KMCH College ‘Pharmacovigilance - An Industry Perspective’ of Pharmacy, Coimbatore – 15th Sep 2012

Honorary Positions SNo

Name of the organization

Capacity (Designation in the forum)

Indian Medical Association - National

No of years / Period

Chairman, Since Jan 2021 Pharmacovigilance Standing Committee (National)

1

Indian Medical Association – Tamil Chairman, Nadu State Branch Pharmacovigilance Standing Committee

Jan 2018-Dec 2020

2

Indian Medical Association Coimbatore Branch

Jan 2013 – Dec 2013

- Joint Secretary

21 of 328


3

Indian Medical Association Coimbatore Branch

- Managing Committee Member

Jan 2012 – Dec 2012

4

Drug Information Association

5

Pharmaceutical Information & Fellow Pharmacovigilance Association, United Kingdom

6

Indian Society for Clinical Research

Chair of Apr 2015 - Mar 2019 Pharmacovigilance Council

7

Indian Society for Clinical Research

Executive Committee Apr 2013 - Mar 2015 Member Apr 2017 – Mar 2019

Regional Editor India Apr 2017 – Mar 2019 of DIA’s official magazine ‘Global Apr 2019 – Mar 2021 Forum’ Since Apr 2021 Since Jan 2015

Apr 2019 – Mar 2021 Since Apr 2021 8

Faculty of Pharmaceutical Medicine Affiliate Member of the Royal Colleges of Physicians in the UK

Jan 2013 – Dec 2017

9

International Society Pharmacovigilance

Since Jan 2016

10

Diabetes in Asia Study Group

Life Member

Since Feb 2012

11

Research Society for the Study of Life Member Diabetes in India

Since Jan 2008

of Member

Other credentials SNo 1

Details VELS University

Descriptions Member – Board of studies (Biotechnology) 2011 – 2012 (12 months)

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2

PSG College of Arts & Science

Member – Board of studies (Biotechnology) 2011 – 2013 (2 years)

3

Kumarguru College of Technology

Member – Board of studies (Biotechnology) 2017 to current

Details of Active Social work and in various medical projects. SNo

Details of Active Social Work

1

Conducted several medical camps for 2006 to 2013 Diabetes detection

2

Career training and counseling for 2010 to 2013 medical, paramedical and life sciences graduates in pharma and healthcare fields

Topics/ Period etc

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Oviya MedSafe‟s First Newsletter Oviya MedSafe – Pharmacovigilance Physician Services April 2012

Dear Colleagues, I am pleased to take this opportunity to introduce my new venture ‘Oviya MedSafe’ to you in greater detail. Oviya MedSafe is a hi-tech startup Pharmacovigilance Consulting Firm based out of the growing IT and Healthcare city of Coimbatore in India, offering Medical & Safety Services to the highly specialized field of Pharmaceutical R & D. Oviya MedSafe has Pharmacovigilance Physician Services as its core competencies. Founded and headed by Dr J Vijay Venkatraman, a Drug Safety Physician with rich clinical and industry experience, Oviya MedSafe has brought together a panel of Physicians and Healthcare Professionals to build a formidable team that would provide high quality medical review services to pharmaceutical companies, contract research organizations and investigators. Oviya MedSafe has been positioned to leverage its expertise in Pharmacovigilance, in an industry which is highly segmented. We are capable of providing modular solutions in terms of Drug Safety Physician Services. We aspire to bridge the crucial gap in the industry where High Quality Medical Reviewers are always in demand. We strive to cater to pharmaceutical companies and CRO’s looking to get expert unbiased medical reviews. With a panel of highly experienced medical review safety physicians, the till now critical review function can now be outsourced. Not only it is cost effective, but the highest quality levels are maintained. Your data confidentiality is our highest priority. Therefore, our unique business model ensures that your data never has to leave your company. We have the required infrastructure as well as qualified resources to work on your systems from our global delivery centre. As we are a start up, we bring a lot of energy and dynamism to the table, along with years of medical experience. Contact us with your requirements and be assured of unique and unparalleled services. Our key services offered include: – Medical Review of Individual Case Safety Reports 25 of 328


– Narrative Writing for Clinical Trial & Spontaneous Cases – Post-marketing Surveillance Studies – Turnkey Projects in Pharmacovigilance If you think we can help you in any other function, do let us know. We shall be glad to discuss how we could work together. For more information, toinfo@oviyamedsafe.com.

please

visit www.oviyamedsafe.com or

send

an

e-mail

Follow us on: Twitter: www.twitter.com/OviyaMedSafe Facebook: www.facebook.com/OviyaMedSafe LinkedIn: www.linkedin.com/company/Oviya-MedSafe With thanks & regards, Dr J Vijay Venkatraman. Founder & CEO, Oviya MedSafe Oviya MedSafe – An Event Partner of ‘3rd Annual Pharmacovigilance Asia 2012’ May 2012 Dear Colleague, Greetings from Oviya MedSafe, a high tech Pharmacovigilance Consulting Firm based out of Coimbatore (one of India’s established healthcare cities and fast growing IT hubs) offering Medical & Safety Services to the highly specialized field of Pharmaceutical R & D! While thanking you for the positive response shown to our previous e-mail with details on Oviya MedSafe and its services sent a month ago, we are happy to share with you the first milestone of Oviya MedSafe that it has reached within 3 months since its founding in March 2012. Oviya MedSafe has been selected an Event Partner of the 3rd Annual Pharmacovigilance Asia 2012, an international conference of all stakeholders in Pharmacovigilance to be held at Singapore on September 18 & 19, 2012. The event is being organized by IQPC, which provides business leaders with the world’s leading conferences.

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For more details on the event, please visit www.oviyamedsafe.com and click on the homepage banner. You are also welcome to go to www.pharmacovigilanceasia.com and read about us by clicking on our logo in the Event Partners section and scrolling down. We at Oviya MedSafe believe this is an important opportunity for us to meet various stakeholders in Pharmacovigilance across the world and join the event organizers in inviting you to register for this grand convention. We look forward to having detailed discussions with you at Singapore and find areas of mutual professional and business interests where we can possibly work together in future.

Pharmacovigilance Asia 2012 – Get regulatory updates from 6 countries in just 2 days July 2012 Dear Colleagues, Oviya MedSafe Private Limited thanks you very much for the interest you showed in response to our previous newsletter highlighting our prestigious association with IQPC as event partners for their 3rd Annual Pharmacovigilance Asia 2012 summit to be held at Singapore on September 18 & 19, 2012. In continuation with our previous newsletter, we take this opportunity to reveal more details about this conference. As you know, the pharmacovigilance regulatory updates across Asia are getting tougher and stricter. And that's why our partners at IQPC felt that it's important to highlight this at the 3rd Annual Pharmacovigilance Asia 2012 summit. With a full day dedicated to PV regulatory updates across Asia, you will never get a better chance to sit at the same table and strengthen working relations with:      

Yagya Prasad Neupane, Chairman, Nepal Pharmacy Council Dr. Wenmin Du, Executive Director, Shanghai Centre for Adverse Drug Reaction Monitoring, SFDA Dr Y K Gupta, Head, National Pharmacovigilance Programme, India Angela On, Chief Executive Director, Taiwan Drug Relief Foundation Dr. Nguyen Hoang Anh, Responsible for Drug Information, Vietnam National Centre for Drug Information and ADR Reporting Mohamad Khalid Haji Zolkipli, National Adverse Drug, Reaction Monitoring Centre, Department of Pharmaceutical Services, Ministry of Health Brunei Darussalam

Of course, they also have a special guest from the Director (Vigilance Branch) of Health Science Authority (HSA), Singapore. 27 of 328


Many other PV experts across the whole of Asia have also confirmed their attendance for the event. Download the brochure to find out who they are.

If you're already convinced, register now and join the power-packed attendance of PV experts in one room, and save up to SGD3696 from the early bird discounts now which close on Friday, July 13th, 2012. Join them and benefit by learning:      

Regulatory updates on pharmacovigilance from WHO's Uppsala Monitoring Center, European Commission, China, India, Taiwan, South Korea, Brunei and Vietnam How you can develop and implement risk management and minimisation plans for improved drug safety How you can prepare for audit and inspection: practical steps to get it right How you can establish an early signal detection system for improved drug safety Best practices in AE reporting for post-marketing surveillance studies How you can achieve compliance in various Asian country regulations while meeting global safety requirements

Save up to SGD3,696 when you register before July 13th, 2012:   

Email: enquiry@iqpc.com.sg Web: www.pharmacovigilanceasia.com Call: +65 6722 9388

Ma Foi Group invests in Oviya MedSafe Pvt Ltd August 2012 Dear Colleagues, Greetings from Oviya MedSafe! While we are always glad to reconnect to you through our newsletter periodically, this edition is more special for us as we make a couple of important announcements which would define the future growth of Oviya MedSafe to a leading full-service global Pharmacovigilance Consulting and Services Company. The global delivery center of Oviya MedSafe Pvt Ltd is based out of Coimbatore - a growing IT hub and established Healthcare city in India. A brief yet descriptive professionally made video on the business potential of Coimbatore city can be viewed 28 of 328


at http://www.youtube.com/watch?v=nHtLLxXUTfI (Disclaimer: A link to this video is shared here as it is available in the public domain and we are neither aware of any copyright violation issues nor are associated with the makers of the video in any way). We are proud to announce that the internationally renowned Ma Foi group, through its group company Ma Foi Strategic Consultants Pvt Ltd (www.mafoistrategy.com) has invested to the tune of 17.5% of the total equity in Oviya MedSafe Pvt Ltd. Ma Foi will provide strategic and operational support for Oviya MedSafe on an ongoing basis. Mr K Pandiarajan, Founder of the Ma Foi group and Managing Director of Ma Foi Strategic Consultants Pvt Ltd has joined the board of directors of Oviya MedSafe Pvt Ltd. We are also in the process of setting up our advisory panel and welcome experienced pharmacovigilance professionals with no conflicts of interest to express their willingness to be considered for membership in the panel. With our core focus on pharmacovigilance physician services, we are also working on establishing full-fledged pharmacovigilance services and are also planning to branch out into pharmacovigilance consulting for pharmaceutical companies, governmental and non-governmental health organizations. We are keen to identify strategic partners who would be able to see synergy with Oviya MedSafe and work with us on a win-win model that would harness the unique strengths of all the entities involved. Location or nationality would not come in the way of the decision-making process when we finalize on such partnerships. If you are interested in meeting us in person for a discussion, we will be happy to invite you to Coimbatore. We can also meet with prior appointment either in Mumbai on 31-Aug-2012 at the 3rd Annual Pharmacovigilance Conference organized by Virtue Insight and/or in the IQPC 3rd Pharmacovigilance Asia 2012 conference in Singapore on September 18th and 19th, 2012. Oviya MedSafe's key services would include: - Individual Case Safety Reports & Aggregate Reports - The Complete Life Cycle - Narrative Writing & Review for Clinical Trial and Spontaneous Cases - Post-marketing Surveillance Studies - Planning and Execution - Turnkey Consulting Projects in Pharmacovigilance If you think we can help you in any other function, do let us know. We shall be glad to discuss how we could work together. For more information, please visit www.oviyamedsafe.com or send an e-mail to info@oviyamedsafe.com.

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Follow us on: Twitter: www.twitter.com/OviyaMedSafe Facebook: www.facebook.com/OviyaMedSafe LinkedIn: www.linkedin.com/company/Oviya-MedSafe

Meet 60+ Pharmacovigilance Experts on Sep 18 & 19, 2012 at Singapore! September 2012 Dear Colleague,

Oviya MedSafe takes great pleasure in joining the organizers of the 3rd Annual Pharmacovigilance Asia 2012 summit, in inviting you to be part of the grand and resourceful event to be held at Singapore on September 18 & 19, 2012! As an event partner of the stellar professional gathering, it is our pleasure to quote from the conference organizers the names of the well-known brands in the Pharmacovigilance space who have confirmed their attendance so far: Heads of Pharmacovigilance, Regulatory Affairs and Clinical Operations from:           

Bristol-Myers Squibb Cipla Eli Lilly Japan Genentech Hospira Johnson & Johnson Lupin Ministry of Health, Singapore Novartis Sanofi-Aventis Takeda

PLUS many more - Get the full attendee list from enquiry@iqpc.com.sg today! If you've always wanted to learn the secrets of:

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   

Achieving compliance in various country regulations in Asia while meeting global safety requirements via 9 regulatory updates from WHO, China, India, Taiwan, South Korea, Malaysia and Brunei Developing and implementing risk management and minimisation plans for improved drug safety Preparing for audit and inspection via practical steps to get it right Establishing an early signal detection system for improved drug safety Best practices in AE reporting for post-marketing surveillance studies

Then, register now! What's more? There is a special 15% discount in the conference registration fee for the subscribers of Oviya MedSafe's newsletter, of whom you are one! To avail the benefit, quote "CM15 " when you register at enquiry@iqpc.com.sg and save up to SGD4,096! For further assistance, please contact the organizers directly at: Web: www.pharmacovigilanceasia.com Email: enquiry@iqpc.com.sg Tel: +65 6722 9388 We look forward to meeting you next fortnight at Singapore! PS: Just 6 seats left for the workshops! Contact enquiry@iqpc.com.sg now for more details.

Oviya MedSafe – Your Strategic Pharmacovigilance Partner October 2012 Dear Friends & Colleagues, Greetings from Oviya MedSafe - your future strategic partner for Global Pharmacovigilance! I am pleased to meet you all through the October 2012 edition of Oviya MedSafe's monthly newsletter. In this edition, I would like to speak about the growth plans we have for Oviya MedSafe for the next few months and invite you to be part of our growth story.

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As you might already know, Oviya MedSafe is all set to offer the following services to global pharmaceutical companies, contract research organizations and other health agencies from mid January 2013: - End-to-end Processing of ICSR's including Medical Review - Narrative Writing for Clinical Trial & Spontaneous Cases - Aggregate Report Writing & Review - Literature Search & Review - Post-marketing Surveillance Studies - Turnkey Projects in Pharmacovigilance In the next phase, we also intend to provide value additions in terms of analytical insights in pharmacovigilance by harnessing the expertise of Ma Foi Analytics who are one of the key stakeholders in Oviya MedSafe and have their related core strength in Healthcare Analytics. We also consider rendering pharmacovigilance consulting to generic pharmaceutical companies, especially in the emerging markets, as a significant part of our growth plan in the years to come. Oviya MedSafe's pharmacovigilance consultants and panel of physicians are in the process of finalization of recruitment and will formally be part of the team shortly. To ensure continuity of availability of trained drug safety professionals and confidently assure scalability of our outsourced services, Oviya MedSafe has partnered with Cliniminds - India's largest Pharmacovigilance Training Institute. We are also actively forming academic collaborations with universities and colleges to nurture our knowledge capabilities on an ongoing basis. Oviya MedSafe welcomes interested pharmacovigilance professionals with specific and rich experience in any of the above-mentioned services to send in their proposals for us to work together. Though Oviya MedSafe would principally operate through its full-time staff from its global delivery centre in Coimbatore, remote working and on-demand consultant models can be considered, subject to the nature of the projects, regulatory acceptance and logistic convenience. Oviya MedSafe's technical team would ensure the information security is maintained with utmost care, in any case. We are keen to identify project partners overseas who would see synergy with Oviya MedSafe and work with us on a win-win model that would integrate the unique strengths of both the entities involved. And, to sign off with some good news, we are glad to share with you that Oviya MedSafe has been featured on the India page of the website of PACRA - Pan Asian Clinical Research Organization, which can be viewed here.

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We hope you had an interesting read and would be interested to hear more from you in response. Do visit us at www.oviyamedsafe.com and feel free to write to info@oviyamedsafe.com with your thoughts.

First peer-reviewed publication from Oviya MedSafe November 2012 Dear Friends & Colleagues, I am glad to bring you warm Deepavali Wishes and the Season's Greetings from Oviya MedSafe your potential strategic partner for Global Pharmacovigilance, through the November 2012 edition of our monthly newsletter! In this edition, I am happy to share with you a milestone that Oviya MedSafe has reached a few days ago - our first peer-reviewed publication! At this juncture, I thank renowned diabetologist Dr V Mohan and his team (especially Dr S Chandru) who invited Oviya MedSafe to work along with them on an article emphasizing on the need for pharmacovigilance of the anti-diabetic drug Pioglitazone the usage of which has been linked to the causation of cancer of the urinary bladder. Our peer-reviewed article titled 'Need to Increase Awareness Among Urologists Regarding the Possible Association Between Pioglitazone and Bladder Cancer' has been published in the Indian Journal of Clinical Medicine on 08-Nov-2012. The free full-text of the article can be downloaded and read by visiting the URL of the publisher http://la-press.com/article.php?article_id=3414. We hope you will find the article interesting and we are keen to receive your feedback on this article. Do visit us at www.oviyamedsafe.com and feel free to write to info@oviyamedsafe.com with your thoughts.

Oviya MedSafe – Vision, Mission & Values December 2012 33 of 328


Dear Friends & Colleagues, I am glad to wish you 'Merry Christmas' and 'Happy New Year' in advance, on behalf of Oviya MedSafe - your strategic partner for Global Pharmacovigilance, through the December 2012 edition of our monthly newsletter! In this edition, I am happy to share with you the recently evolved Vision, Mission and Value statements of Oviya MedSafe! Crafted with a lot of zeal and genuineness, we have ensured that these statements reflect our undaunted commitment towards pharmacovigilance, as follows: Vision: 

To become a leader in pharmacovigilance consulting services by strategically partnering with global pharmaceutical companies.

Mission: 

To inculcate a pharmacovigilant culture and proactively support the growth of drug safety practices across the globe. We will achieve this by integrating our expertise in pharmacovigilance with our medical experience, ensuring compliance to the dynamic regulatory frameworks and deploying the most appropriate technology.

Values:    

Passion for Pharmacovigilance Continuous learning to empower clients Perpetual capability building Deep-rooted business integrity

We firmly believe that these core statements will be the key stimulants for our growth and development. We trust we will be able to make a significant difference not only in India but globally as well, in our highly focused single-minded objective of pharmacovigilance. I would also take this opportunity to share with you my second publication in 2012 (on Pioglitazone) titled "Eight Cases of Bladder Cancer in Pioglitazone users from India" published in the Correspondence section of the Journal of the Association of Physicians of India in its December 2012 issue, which can be freely read here: http://www.japi.org/december_2012/18_correspondences.html. It is my privileged duty to thank all my co-authors who made this publication possible, especially the corresponding author Dr V Mohan.

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I am particularly pleased to mention here about the 'Pharmacovigilance India' LinkedIn Group (http://www.linkedin.com/groups?home=&gid=839337) founded by me on 12-Sep-2008, which had its 3000th member on 13-Dec-2012. We at 'Pharmacovigilance India' wish to grow more and more in numbers as well as in our understanding on what we want to achieve together so that we emerge as a solid support group for all Pharmacovigilance activities in India, in the years to come. Another important activity we had this month was my talk titled "Pharmacovigilance - An Emerging Medical Specialty" at MEDITEX 2012 - the 67th Annual Conference of the Indian Medical Association (Tamil Nadu State Branch) at Coimbatore on 16-Dec-2012. The idea of the talk was to showcase pharmacovigilance as a career option for young doctors in India. I am hopeful that bigger numbers of doctors in India will look at the option of taking pharmacovigilance as their careers, very soon. Do visit us at www.oviyamedsafe.com and feel free to write to info@oviyamedsafe.com with your thoughts. We are waiting to hear from you 

Pharmacovigilance Service Offerings from Oviya MedSafe January 2013 Dear Friends & Colleagues, At the outset, I take pleasure in wishing you a very Happy and Prosperous New Year 2013, on behalf of Oviya MedSafe - your strategic partner for Global Pharmacovigilance, through the January 2013 edition of our monthly newsletter! I am glad to share with you that Oviya MedSafe has started working on its first international project for a reputed client in Europe, in the domain of Signal Detection support services, since December 2012. We at Oviya MedSafe are confident of taking up a variety of tasks in the wide spectrum of Pharmacovigilance and delivering the best quality services, well within the committed deadlines and in line with the global drug regulations. Please find attached a brief presentation on Oviya MedSafe's strengths and capabilities. I am keen to know your comments on the presentation and will be happy to discuss potential opportunities for Oviya MedSafe to work with you. Oviya MedSafe plans to organize and also ensure its presence in quite a number of events this year which I believe will position us strongly in the pharmacovigilance industry, starting from our 35 of 328


participation in the 6th Annual Conference of the Indian Society for Clinical Research (ISCR) at Mumbai on 4th and 5th of January 2013. I will be delighted to meet you in person at Mumbai during the conference and explain our service offerings to you in detail. If this is of interest to you, kindly reply to this message with your contact details so that we can meet you at a mutually convenient timing during these days. In case these dates are not convenient for you, I will be happy to meet you with your prior appointment at any time on any day between 11th and 13th of January 2013 when I will be in Mumbai again. Before signing off, I am glad to place on record that my talk on the topic "Pharmacovigilance - An Emerging Medical Specialty" at MEDITEX 2012 - the 67th Annual State Conference of the Indian Medical Association (Tamil Nadu State Branch) at Coimbatore on 16-Dec-2012 was received very well and I am hopeful that it will encourage more physicians to take up pharmacovigilance as a career. Looking forward to meeting you with more and more of interesting news in the next edition,

Invitation to the Launch Event of Oviya MedSafe – Our Pharmacovigilance Company February 2013 Dear Friends, Colleagues & Well-wishers, On behalf of our management and staff, I take great pleasure in cordially inviting you to the launch of Oviya MedSafe Pvt Ltd, our Pharmacovigilance Consulting & Services company, based out of Coimbatore in India. The event will be held at The Residency Hotel, Coimbatore between 4 PM and 5:30 PM on Saturday, 23-Feb-2013. Mr Yagya Prasad Neupane, Chairman of Nepal Pharmacy Council, will be the Chief Guest of the day and launch the company. Mr Moin Don, who has agreed to conduct a workshop titled 'Pharmacovigilance for Aspiring Professionals' prior to the launch, will be the Guest of Honour at the launch. Registration for the workshop is not mandatory for attending the launch event. Dr L P Thangavelu, the President and Dr J A Jayalal, the Secretary of the Indian Medical Association (Tamil Nadu State Branch) will felicitate the function. Mr Sudhir Kandarth from Oracle and Mr Balaji Raju from AES Technologies have also agreed to feliciate.

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It will be our privilege to host you at the event. Please find attached the e-invitation. In case you use a text-only e-mail option, you may not be able to view the invitation image. Kindly contact us if you would like the e-invitation sent to you as an attachment in a separate e-mail. To tell us the good news that you are attending the event, please call us on +91-94422-25311 / 0422-2444442 or write to register@oviyamedsafe.com in advance, so that we will be prepared to host you to our heart's content.

Pharmacovigilance Workshop by Moin Don at Coimbatore on 23-Feb-2013 February 2013 Dear Colleagues, Greetings from Oviya MedSafe! We are glad to share with you that we have organized a workshop titled 'Pharmacovigilance for Aspiring Professionals' by renowned speaker Mr Moin Don, at The Residency Hotel, Avinashi Road, Coimbatore on Saturday, 23-Feb-2013 between 8 AM and 3 PM.

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Doctors, Alternative Medicine / Veterinary Medicine graduates, Dentists, Pharmacists, Physiotherapists, Nurses and all professionals with life science backgrounds aspiring to become Pharmacovigilance Professionals would find this workshop most useful. Clinical research investigators, co-ordinators and site staff can make best use of this opportunity to update their knowledge on the pharmacovigilance practices adopted in the industry. Drug Safety / Clinical Research professionals working in the industry, members of the academia and practising doctors are also welcome to attend. The program includes interactive discussions and problem-solving exercises. Certificates would be awarded after the event, to all the attendees. Registration deadline: 20-Feb 2013, 6 PM. NO SPOT REGISTRATION. For more details on the workshop and to register for attending it, please refer to the workshop brochure and the registration form which can be downloaded from the following links: Workshop Brochure - http://oviyamedsafe.com/pvworkshop.pdf Registration Form - http://www.oviyamedsafe.com/register.pdf We firmly believe that this workshop will inspire and encourage more students and young aspiring professionals to take up pharmacovigilance as their preferred career choice. Please contact us on +91-422-2444442 / +91-94422-25311 or write to us at register@oviyamedsafe.com, if you need any more information regarding this workshop or have any queries in the registration process. Looking forward to making this event successful with support from all of you,

Oviya MedSafe – Pharmacovigilance flows from February March 2013 Dear Friends & Colleagues, I am glad to meet and greet you through the March 2013 edition of the newsletter of Oviya MedSafe Private Limited - our Pharmacovigilance Consulting & Services company! With the month of February 2013 having been eventful and enthusiastic for us, it is my pleasure to share with you some snippets of the landmarks of our interesting journey so far, which we crossed during the vibrant month. 38 of 328


On 07-Feb-2013, Ma Foi Strategic Consultants Pvt Ltd convened a press meet at Chennai to formally announce their investment in Oviya MedSafe, which was our first opportunity to engage the media on pharmacovigilance. The event also provided a platform for Ma Foi to explain the background of Ma Foi making the early stage investment in Oviya MedSafe and also elucidate on the long-term plans by which Ma Foi's strengths would be leveraged to Oviya MedSafe's advantage and vice versa. The photos of the event can be viewed here. The following are the links to some of the key news reports that followed the press meet:      

The Hindu Business Line - Ma Foi Strategic acquires 17.5% stake in Oviya MedSafe The Financial Express - Ma Foi enters pharma consulting, picks stake in Oviya MedSafe Pharmabiz - Physicians in Coimbatore launch co offering pharmacovigilance services Business Standard - Ma Foi Strategic acquires stake in Oviya MedSafe Financial Chronicle - Ma Foi eyes outsourcing in pharmacovigilance Sulekha - Ma Foi enters Indian pharma segment (Detailed Coverage)

Following the successful press meet, Oviya MedSafe organised a workshop titled 'Pharmacovigilance for Aspiring Professionals' by renowned speaker Mr Moin Don, to mark the formal launch of the company on 23-Feb-2013 at Coimbatore. The workshop was chaired by Mr Yagya Prasad Neupane, Chairman of Nepal Pharmacy Council, Kathmandu. Mr Neupane was also the chief guest for the launch of the company, which was felicitated by Dr L P Thangavelu and Dr J A Jayalal, the President and the Secretary of the Indian Medical Association - Tamil Nadu State Branch respectively. Mr Sudhir Kandarth from Oracle Health Sciences Global Business Unit also felicitated the function.

A detailed report on the workshop and the inauguration is available here. We are happy to share the complete set of photographs of the events, which can be viewed here. Our pharmacovigilance initiatives at Coimbatore received very positive coverage in The Hindu and Pharmabiz with the other media to follow up shortly. The URL's of the articles are shared below:  

The Hindu - Efforts on to monitor safe use of drugs Pharmabiz - Benefit-risk ratio of all drugs should be monitored through pharmacovigilance studies: Neupane

Following the formal launch of the company, our global delivery centre at Coimbatore has now become fully operational, with a robust drug safety team consisting of experienced as well as entry level pharmacovigilance professionals. With this strong team, we are confident of providing end-toend pharmacovigilance support. We are pleased to inform you that we have in-house capabilities for writing risk management plans, the requirement of which has now become more frequent, after the implementation of the new EU regulations. On the event front, we are exhibiting at the 4th Pharmacovigilance Conference of the Drug 39 of 328


Information Association India at Bangalore on March 8th & 9th, 2013. Oviya MedSafe has also been given an 'Event Partner' status consecutively for the second year by IQPC Singapore, a leading global conference management company, for their 4th Annual Pharmacovigilance Asia 2013 conference which is scheduled to happen from 18th to 21st June, 2013 at Singapore. Before concluding, I would like to share with you three professional recognitions I received during the past 2 months, as follows:   

Executive Committee Member - Indian Society for Clinical Research - April 2013 to March 2015 Affiliate Member - Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom - 2013 Joint Secretary - Indian Medical Association, Coimbatore Branch - 2013

I believe that with the help of the above-mentioned positions and your consistent support, I will be able to put in my best efforts for the larger cause of Indian Pharmacovigilance, which is of course a shared goal for all of us, beyond business interests. I thank you very much for your patient reading of this long letter and am keen to respond to your comments and questions, which you may have. Looking forward to meeting you in April 2013 with more interesting news,

Oviya MedSafe – Specialists in Risk Management Planning in Pharmacovigilance April 2013 Dear Colleagues, I am immensely happy to reach out to you through the April 2013 edition of Oviya MedSafe's newsletter. Oviya MedSafe was launched at a stellar event at Coimbatore on 23-Feb-2013, about which you would have read in our previous edition. March 14th 2013 was special to us as we celebrated the first anniversary of the founding of our brand 'Oviya MedSafe'. It was a moment of pride for our management and staff to recollect our steady growth from being just a concept with a logo in March 2012 to a full-fledged pharmacovigilance consulting & services company with international clients and a robust operational team with experienced leaders at the helm of affairs, in March 2013. Oviya MedSafe had its first experience as an exhibitor in the 4th Pharmacovigilance Conference of the Drug Information Association at Bangalore on March 8th & 9th 2013. We had a good number 40 of 328


of visitors to our stall who were keen to know about our pharmacovigilance services. Our corporate presentation on Oviya MedSafe's capabilities in pharmacovigilance is attached with this letter. Oviya MedSafe's event partnership with IQPC Singapore continues for the second consecutive year for the 4th Annual Pharmacovigilance Asia 2013 which is to be held between 18th and 21st June 2013. We take pleasure in inviting you to this conference on behalf of the organizers and firmly believe that it will provide a 360-degree perspective of the pharmacovigilance activities with respect to the Asian continent. Please do write to us for more information on this event. At this juncture, I am also glad to share with you that I have been asked to author a 2-part series on Pharmacovigilance for publication in the popular pharma magazine Pharma Bio World. The first article on Indian Pharmacovigilance has already been published in the March 2013 edition which is in circulation now. The second article titled 'Pharmacovigilance Outsourcing and Career Advantages for Indian Professionals' will be published in the April 2013 edition. I would be glad if you could read the articles and provide your valuable feedback. I will share the PDFs of the articles with you once they are e-published. On the projects' front, Oviya MedSafe is approaching the completion of a signal detection support project from a European client and will start working on managing the Individual Case Safety Reports (ICSRs) of another client from Europe shortly. We have also started to work with a couple of pharmaceutical companies in various parts of the world on consulting projects. Before concluding this letter, I am pleased to place on record that we have an in-house team with expertise and experience in writing Risk Management Plans (RMPs) as well as Risk Evaluation and Mitigation Strategies (REMS), which is our featured service for this April 2013 edition of our newsletter.

Risk Management Planning - What, Why & When? In many countries, distinct drug safety plans are required as part of a medicine‟s approval process and to retain its approved status. These plans are mandated by: • ICH Harmonized Tripartite Guideline - Pharmacovigilance Planning - E2E • Guideline on Good Pharmacovigilance Practices (GPvP) Module V – Risk Management Systems • The U.S. Food and Drug Administration Amendments Act (FDAAA) and the FDA‟s Guidance for Industry Format and Content for Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications

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Recognizing even prior to the enactment of such legislation and regulations that clinical studies do not necessarily represent real-world experience, pharmaceutical companies often designed Risk Management Plans in the pre-approval stages of developing new medicines and included them in submissions for approval. This type of a plan, or system, may be defined as a set of pharmacovigilance activities designed to identify, characterize, prevent, or minimize risks related to the medicine; to assess the effectiveness of those interventions; and to communicate those risks to patients and health care providers. In Europe, Risk Management Plans (RMPs) are now routinely required by the European Medicines Agency as part of the medicine approval process. A Risk Evaluation and Mitigation Strategy (REMS) is developed to help ensure that the benefits of a medicine outweigh its risks. REMS may be required by the FDA as part of the approval process for a new product, or for an approved product when new safety information emerges. An applicant may also voluntarily submit REMS. Oviya MedSafe is capable of providing all services covering the entire life cycle of Risk Management Planning. We are keen to work with you on your RMPs and would be delighted to answer any questions that you may have in this regard. Looking forward to meeting you through our May 2013 newsletter,

Oviya MedSafe’s new capabilities & credentials in Pharmacovigilance May 2013 Dear Colleagues, Season's greetings from Oviya MedSafe - your strategic partner for Pharmacovigilance! I take great pleasure in e-meeting you through the May 2013 edition of Oviya MedSafe's newsletter. I am glad to share with you about Oviya MedSafe's advancements during the past month which have assured us that we are constantly progressing further in our journey towards excellence in providing global pharmacovigilance consulting and end-to-end managed medical affairs & drug safety services, to our clients. To start with, I am immensely happy to announce that Oviya MedSafe now offers Pharmacovigilance Call Centre Services also. As an expansion of our medical information function, our call centre arrangement would help our clients by receiving inbound calls meant for consumers or healthcare professionals to report suspected adverse drug reactions and by performing outbound 42 of 328


telephonic follow-ups with the reporters. We believe that this new strength will add a lot of value to our existing credentials of capable pharmacovigilance staff, state-of-the-art information technology facilities and safety database provisions. Oviya MedSafe is proud to place on record that Mr Ganesan Ramakrishnan - our Drug Safety Manager, has been invited to share his experiences on the topic 'Pharmacovigilance for Clinical Trials in India' at the 4th Annual Clinical Trials Summit 2013 organized by Virtue Insight, at the Kohinoor Continental Hotel, Mumbai on Friday, 20th June 2013. I take this opportunity to invite you and your colleagues to attend the event and provide Ganesan as well as me the chance to meet you for a detailed interaction on our services. As you might already know, Oviya MedSafe's event partnership with IQPC Singapore continues for the second consecutive year for the 4th Annual Pharmacovigilance Asia 2013 which is to be held between 18th and 21st June 2013. I take pleasure in inviting you to this conference on behalf of the organizers and firmly believe that it will provide a 360-degree perspective of the pharmacovigilance activities with respect to the Asian continent. Please do write to us for more information on this event. As assured in the April 2013 edition of our newsletter, I now share the full-text PDF version of my article titled 'Pharmacovigilance in India - A Perspective' which was published in the March 2013 edition of the magazine 'Pharma Bio World'. Please click here to download and read it. I am keen to know your feedback on the article and look forward to further one-to-one discussions with you on its contents. I will share in the June 2013 edition of our newsletter my subsequent article titled 'Pharmacovigilance Outsourcing and Career Advantages for Indian Professionals' which has been published in the April 2013 edition of the same magazine. With the International Clinical Trials Day (commemorating 20th May, 1747 - the date on which James Lind, who is considered the originator of clinical trials, started his famous trial to treat scurvy) being around the corner, I, in my capacity as an Executive Committee Member of the Indian Society for Clinical Research (ISCR), request you to vibrantly celebrate this day within your organizations as a day of revelation. I share, with the permission of the Executive Committee, the official note released by ISCR to declare and explain the thoughts behind the ISCR Theme for International Clinical Trials Day 2013: Research Made The Difference. Click here to download, read & share it with your colleagues. Before signing off for the month, I am pleased to let you know that ISCR will be collaborating with the Indian Medical Association - Tamil Nadu State Branch to organize a one-day workshop on Saturday, 29-June-2013 at Chennai on the topic 'Fundamentals of Drug Development - For Medical Students & Practising Doctors' for improving awareness of clinical research as a science, among the non-investigator physicians and the young doctors in this part of the country. More information will be made available soon and you will also shortly hear from us on the agenda 43 of 328


for the day along with the registration details. I request for your kind co-operation to make this workshop a grand success. Looking forward to meeting you through our June 2013 newsletter,

Pharmacovigilance Outsourcing & International Clinical Trials Day – Notes from Oviya MedSafe June 2013 Dear Colleagues, I am pleased to reach out to you through the June 2013 edition of Oviya MedSafe's newsletter. As you might have come to know, Oviya MedSafe has evolved into a full-fledged Global Pharmacovigilance Consulting & Drug Safety Services company, capable of handling any activity ranging from end-to-end processing of Individual Case Safety Reports to writing Risk Management Plans. We believe that the recent inclusion of call center support to our portfolio of services is of a unique value addition to our existing credentials of capable pharmacovigilance staff, state-of-the-art information technology facilities and drug safety database provisions. Though Oviya MedSafe primarily focuses on the safety of marketed drugs, May 2013 was a 'Clinical Trial' month for us with our staff observing the 'International Clinical Trials Day' on 20May-2013 in novel ways ranging from educating their friends & families on the background of the day to expressing among their peers the benefits that Clinical Research has rendered to mankind, with examples. The occasion was further decorated with The Hindu (South India's leading English daily newspaper) interviewing me in my official capacity as an Executive Committee Member of the Indian Society for Clinical Research and publishing it. Please click here to read the interview feature on The Hindu's website. To share any comments you may have regarding the interview, kindly write back to me. I am glad to acknowledge and thank all of you who sent your comments in response to my article titled 'Pharmacovigilance in India - A Perspective' published in the March 2013 edition of the magazine 'Pharma Bio World', which was featured in the May 2013 edition of our newsletter. Now, I take the pleasure of sharing the full-text PDF version of my second article in the series titled 'Pharmacovigilance Outsourcing and Career Advantages for Indian Professionals', which was published in the April 2013 edition of the same magazine. Please find it attached. The article can also be read online and downloaded from this link. I am keen to know your feedback on this article too and would be glad to discuss any queries you may have in this regard. 44 of 328


Oviya MedSafe's tryst with 'Clinical Trials' continues this month too, with our Drug Safety Manager Ganesan Ramakrishnan all set to talk on 'Pharmacovigilance for Clinical Trials in India' at the 4th Annual Clinical Trials Summit 2013 organized by Virtue Insight, at the Kohinoor Continental Hotel, Mumbai tomorrow (Friday, 7th June 2013). I am with Ganesan at Mumbai and since we will be here till the evening of 08-Jun-2013 (Saturday), we look forward to meeting and interacting with those of you who are based in Mumbai and/or happen to be in Mumbai during this period. Please feel free to reach us on +91-82207-63222, if you would like to discuss potential opportunities for us to work with you. We will be glad to take the discussion forward, while we are here in Mumbai itself. We at Oviya MedSafe take this opportunity to wish IQPC Singapore for their upcoming conference titled 4th Annual Pharmacovigilance Asia 2013, for which we have partnered with them as their event partner for the second consecutive year. The event, which is to be held between 18th and 21st June 2013, will provide a 360-degree perspective of the pharmacovigilance issues of relavance to the Asian continent. Before signing off for the month, I am happy to update you that the workshop planned by the Indian Society for Clinical Research in collaboration with the Indian Medical Association on 29June-2013 is shaping up well and you will soon be receiving the day's agenda along with the registration details. I request support from all of you to make this a event a grand beginning of successes. Looking forward to meeting you through our July 2013 newsletter,

Oviya MedSafe now offers Pharmacovigilance Support for Indian & Middle East markets too July 2013 Dear Colleagues, On behalf of Oviya MedSafe, I am very glad to convey the season's greetings to you through this July 2013 edition of Oviya MedSafe's newsletter. Oviya MedSafe made a mark in June 2013 by simultaneously starting to work with two new pharmaceutical markets - India and the Middle East. It was one of our breakthrough moments when we won the bid to write the Periodic Safety Update Reports (PSURs) meant for submission to the office of the Drug Controller General of India (DCGI), from one of India's largest pharmaceutical companies. At this moment, I think it is worthwhile to add a small note on the regulatory requirements in India for submission of India-specific PSURs, which can be read below: 45 of 328


A Periodic Safety Update Report (PSUR) is a report which is submitted to the regulatory agency at set intervals in the lifetime of a product and provides an update of the safety experiences seen both nationally and globally since the product was authorized. In India, according to the requirements of Schedule "Y" of the Drugs and Cosmetics Rules, PSURs of new drugs are required to be submitted to the office of the DCGI once in six months for the first two years and annually for the subsequent two years. The PSURs due for a period must be submitted within 30 calendar days of the last day of the reporting period in order to: • report all the relevant new information from appropriate sources; • relate these data to patient exposure; • summarize the market authorization status in different countries and any significant variations related to safety; and • indicate whether changes should be made to product information in order to optimize the use of the product. We at Oviya MedSafe are committed to take up the writing of India-specific PSURs as one of our main activities and consider it to be a part of our role in strengthening Indian pharmacovigilance by empowering generic pharmaceutical companies with pharmacovigilance support. We will be glad to extend the service to all Indian and multinational companies, including innovators, who market products in India. Please do contact us if you have a requirement. As I mentioned earlier, our maiden venture in the Middle East market too happened in June 2013, with us being contracted to work on Corrective And Preventive Action plans (CAPAs) for one of the largest drug distributors in the region. And, as it is obvious, we are continuing and rather expanding the range of services which we have been offering to the European and the North American markets so far. On the events' front, I had the opportunity to speak on 'Employment Opportunities in Pharmacovigilance for Indian Professionals' at the National Level Seminar on 'Widening the Horizons for Practising Pharmacists in Industries and Hospitals', organized by the Department of Pharmacy Practice of PSG College of Pharmacy, Coimbatore on July 5th, 2013. I attended the Capacity Building Workshop on Pharmacovigilance in Clinical Trials, conducted by the All India Institute of Medical Sciences, New Delhi on July 16th, 2013. I am happy to mention that I have been shortlisted to participate in the 'WHO Dissemination Workshop on the Clinical Trial Registry of India' organized by the National Institute of Medical Statistics in collaboration with the Centre for Research in Medical Entomology (both being constituents of the Indian Council of Medical Research) at Madurai in Tamil Nadu on July 24th, 2013. 46 of 328


Before signing off for the month, I am pleased to share with you that I have been inducted as a Special Invitee Member of the Pharma Research and Development Association, Ahmedabad, Gujarat (PRADA Global) which aspires to foster R & D activities & support companies, institutes and individuals to grow in their professional and personal domain. I hope I will be able to justify PRADA Global's decision to add me to their board, with all your support and advice. Looking forward to meeting you through our next newsletter edition in August 2013,

Oviya MedSafe: Express Pharma, Indian Pharmacovigilance, Medical Device Vigilance and more! August 2013 Dear Colleagues, Season's greetings from Oviya MedSafe! It is my pleasure to reach out to you through the August 2013 edition of Oviya MedSafe's newsletter! I am immensely happy to announce that Oviya MedSafe has been featured in the special section "Pharmacovigilance: The way forward for India" published in the latest issue of Express Pharma, one of the leading pharmaceutical industry magazines published from India. The article showcases insights from many different personalities in the discipline of pharmacovigilance, in which I have commented on the pharmacovigilance initiatives in India, regulatory compliance trends among companies, clinicians' perspectives of reporting adverse events and suggestions for establishing and successfully running a solid pharmacovigilance system for India. It is noteworthy that a mention has been made by the author about Oviya MedSafe's growth as a pharmacovigilance consulting and outsourcing player in the industry within the brief period of its full-fledged operations since its launch in February 2013. Please visit http://pharma.financialexpress.com/sections/market-section/2507-pharmacovigilance-the-wayforward-for-india to read the complete article and share with us your feedback about it. In continuation with the same topic of Indian Pharmacovigilance, I am glad to share with you that I have been invited as a trainer for the National Training Workshop on "Secured Medicines & Robust Pharmacovigilance - Key to Patient Safety & Health" organised by Partnership for Safe Medicines (PSM) India Initiative and Grahak Shakti in technical Collaboration with the Indian Pharmacopoeia Commission, Ghaziabad which is the National Co-ordinating Centre for the Pharmacovigilance Program of India (a Government of India initiative), on Friday, 23-Aug-2013 at Bengaluru. I have been asked to speak on "Adverse Drug Reaction (ADR) monitoring system its status, awareness, implementation and reach", one of my favourite topics in 47 of 328


Pharmacovigilance. For more information on the workshop, please refer to the day's agenda on PSM's website at http://www.safemedicinesindia.in/Programs_Bengaluru.pdf. I take this opportunity to emphasize on Oviya MedSafe's featured service of the month, namely Medical Device Vigilance (Materiovigilance), which is an integral part of our service portfolio. The principal purpose of Medical Device Vigilance is to improve the protection of health and safety of patients, users of devices and others by reducing the likelihood of recurrence of adverse incidents. This is achieved by evaluation of reported incidents and, where appropriate, dissemination of information, which could be used to prevent such repetitions, or to alleviate the consequences of such incidents. It enables dangerous devices to be withdrawn from the market and eliminate faults in medical devices with the intention of constantly improving the quality of devices and providing patients and users with increased safety. Not only the manufacturers or their representatives but also the persons distributing devices, notified bodies, practitioners and people responsible for receiving and/or delivering the devices should all signal to the regulatory authorities when they come across untoward incidents. Incidents must be notified as quickly as possible using the quickest means possible. Incidents that have led to death or serious injury must be notified immediately. It is relevant to note at this point that I have been requested to talk on "Global Safety Regulations for Medical Devices" at BIOYANTRA 2013 - a National Symposium on Medical Devices organized by the Department of Biomedical Engineering, SRM University, Chennai on 6th and 7th September 2013. I believe this is a significant platform for insisting upon Materiovigilance, given the expected presence of a good number of senior executives from medical device manufacturing and marketing companies at Chennai for the event. I hope to share my experiences during the symposium in our next month's newsletter.

Before signing off for the month, I would like to place on record that I had an opportunity to speak on "Phase IV Trials and Ongoing Drug Safety Management" at the workshop titled "Fundamentals of Drug Development for Pharmacology & Pharmacy Students" organized by the Department of Pharmacology, Madras Medical College in collaboration with the Indian Society for Clinical Research, at Chennai on 17-Aug-2013. I have also been invited to participate as a panelist in the panel discussion "The Road Not Taken" and talk about careers in pharmacovigilance for doctors, on 25-Aug-2013 at Tamil Nadu State CRRI CON 2013 - a state level career guidance workshop for young doctors, organized by the Coimbatore branch of the Indian Medical Association. Looking forward to meeting you with more exciting news in September 2013,

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Oviya MedSafe – Bronze Sponsor of 5th Pharmacovigilance Congregation 2013 September 2013 Dear Colleagues, I am pleased to meet you all through the September 2013 edition of Oviya MedSafe's newsletter, with the greetings of the season! On behalf of Oviya MedSafe, I am proud to announce that Oviya MedSafe has been designated the Bronze Sponsor for the 5th Pharmacovigilance Congregation 2013 organized by Virtue Insight on November 20, 2013 at Kohinoor Continental Hotel, Mumbai, India! With the theme of the congregation being “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management", I am sure it is most appropriate for Oviya MedSafe to partner with Virtue Insight as one of the key sponsors of the event. I am keen to meet many colleagues from the industry at the congregation and also invite you to be part of the professional gathering. I hope to share more information about this event in our next month's newsletter. I am happy to emphasize on Oviya MedSafe's featured service of the month - the preparation of Pharmacovigilance System Master File (PSMF), which is an integral part of our service portfolio. The PSMF is a legal requirement in the European Union. The PSMF shall describe the pharmacovigilance system and support / document its compliance with the requirements. Apart from fulfilling the requirements for a PSMF laid down in the legislation and guidance, it shall also contribute to the appropriate planning and conduct of audits by the applicant or marketing authorizations holder(s), the fulfillment of supervisory responsibilities of the Qualified Person for Pharmaco Vigilance (QPPV), and of inspections or other verification of compliance by national competent authorities. The PSMF provides an overview of the pharmacovigilance system, which may be requested and assessed by national competent authorities during marketing authorization application(s) or postauthorization. Looking forward to meeting you with more interesting news in October 2013,

Pharmacovigilance Services bundled with hosted Drug Safety database solutions from Oviya MedSafe October 2013 49 of 328


Dear Colleagues, It is my pleasure to meet you all through the October 2013 edition of Oviya MedSafe's newsletter and greet you during this festive season! I am glad to announce that Oviya MedSafe now introduces the offering of end-to-end pharmacovigilance services bundled with hosted E2B-compliant drug safety database solutions, which would be of remarkable benefit to small and mid-sized pharmaceutical companies by way of enabling them to be compliant with drug regulations without incurring enormous fixed costs pertaining to the investments that need to be made for installing pharmacovigilance databases in their premises for their exclusive use. With more and more of generic pharmaceutical companies wanting to comply with drug regulations worldwide, we believe this bundled service will be a great value addition to marketing authorization holders across the globe, especially when the number of adverse event reports they expect to handle is either minimal or too variable to predict. Oviya MedSafe believes that this bundled service is the need of the hour, as pharmacovigilance is coming of age in emerging economies also. On this occasion, I am happy to share with you my interview titled Thalidomide Tragedy Revisited which has been published on account of the 50th anniversary of the Thalidomide Tragedy, in the September 2013 issue of Pharma Bio World - a popular pharmaceutical and biotechnology industry magazine published from Mumbai. Thanks to the interviewer Ms Ananya Sen, I had an opportunity to emphasize on the significance of pharmacovigilance and express my views on what all of us have learnt about drug safety as a science during this period of 50 years. Please click here to read the interview and share your feedback. Before signing off for the month, I take the privilege of inviting you to visit Oviya MedSafe's stall at the 5th Pharmacovigilance Congregation 2013, for which Oviya MedSafe is a Bronze Sponsor. As you might know, the event is being organized by Virtue Insight on November 20, 2013 at Kohinoor Continental Hotel, Mumbai. Looking forward to meeting you with more advancements in November 2013,

Oviya MedSafe adds QPPV Services to its Pharmacovigilance Consulting Portfolio November 2013 Dear Colleagues,

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I am enthused to meet you all, through the November 2013 edition of Oviya MedSafe's newsletter, with our greetings for the season! This month marks a milestone in Oviya MedSafe's continual growth into a full-service Pharmacovigilance Consulting Company, as we add Qualified Person for PharmacoVigilance (QPPV) Services to our consulting portfolio. I take this opportunity to share with you some information on the concept of QPPV. In order to market medicinal products within the European Economic Area (EEA), the law requires that a Marketing Authorization Holder (MAH) must first appoint a Qualified Person for PharmacoVigilance (QPPV) who will oversee the company‟s pharmacovigilance system. The QPPV is a highly qualified, highly skilled professional who fulfills a number of roles and responsibilities for the company or the MAH including: • Establishing and maintaining the MAH's Pharmacovigilance System (including all activities which contribute to the detection, assessment, understanding and communication of safety information, as well as risk management activities); • Overseeing the safety profiles of the company‟s marketed products and addressing any emerging safety concerns; • Acting as a single point of contact for the regulatory authorities on a 24-hour basis and being the contact point for pharmacovigilance inspections. The QPPV must be “permanently and continuously at the disposal” of the MAH and must be experienced in all aspects of Pharmacovigilance. This is often a challenge for small to mediumsized companies, as the Qualified Person for PharmacoVigilance must reside within the EEA, and a deputy may be needed as well. Often, companies which are emerging in Europe either do not have the infrastructure locally, or do not have the access to an appropriate individual. Oviya MedSafe is now capable of providing QPPV services for clients entering into the European Union (EU) market to ensure appropriate management of the MAH‟s pharmacovigilance systems in the EU. Personally, I am happy that I will be spending almost the whole of the next week (3rd week of November 2013) in Mumbai to meet various clients and potential clients of Oviya MedSafe. It will be my pleasure to catch up with you too, if you are available in Mumbai during that period. As you might already know, the core reason for my Mumbai visit is Oviya MedSafe's participation as a Bronze Sponsor in the 5th Pharmacovigilance Congregation 2013 organized by Virtue Insight on November 20, 2013 at Kohinoor Continental Hotel, Mumbai. Along with Virtue Insight, Oviya MedSafe cordially invites you to register for the event and, of course, visit Oviya MedSafe's Bronze Sponsor stall at the venue, where we can catch up for quick interactions. 51 of 328


Looking forward to meeting you at Mumbai next week and reaching out to you with more news in December 2013,

Oviya MedSafe – Advantage Coimbatore, Literature Search & Bangalore Events December 2013 Dear Colleagues, On behalf of Oviya MedSafe, I am glad to extend our warm greetings and hearty wishes to you and your family for the festive Christmas and New Year season, through this December 2013 edition of Oviya MedSafe's newsletter! To start with, we at Oviya MedSafe are excited to share with you the excellent performance of our city Coimbatore as one of the top 10 business destinations among 21 Indian cities, ahead of Ahmedabad, Hyderabad, Kolkota, Noida, Gurgaon and so on, in a survey conducted by the Global Initiative for Restructuring Environment and Management, as reported on 11-Dec-2013 in The Hindu. We are happy to highlight Literature Search & Review, as Oviya MedSafe's featured service of the month. Oviya MedSafe offers weekly literature search services for marketed products, both in realtime and retrospectively, either as an addition to any of our drug safety services or as standalone support to an existing pharmacovigilance department of a pharmaceutical company. At Oviya MedSafe, on-going product surveillance is carried out competently to manage high hit rates efficiently and effectively. The search results are screened by qualified staff and the individual cases are tracked through a workflow process which facilitates prompt expedited reporting and ensures a complete audit trail. Whenever cases need to be expedited to regulatory authorities, we order published articles and arrange translations on behalf of our clients. We present a brief overview of the most important literature monitoring regulations in the European Union (EU), as follows: • European Medicines Agency (Agency) shall monitor selected medical literature for reports of suspected adverse reactions to medicinal products containing certain active substances; • Marketing Authorization Holders (MAHs) shall only submit Individual Case Safety Reports (ICSRs) published in scientific and medical literature for those journals and active substances not monitored by Agency;

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• Until the lists of journals & active substances are published by Agency, MAHs should monitor all their active substances by accessing widely used systematic literature review and reference databases. The exceptions for not reporting ICSRs are: • Where ownership of medicinal product by MAH can be excluded based on active substance name, formulation, route of administration, primary source country or country of origin of reaction; • Reports from literature articles presenting summary data analysis from publicly available databases or detailing patients in tables or line listings; • Reports from literature articles based on analysis from National Competent Authorities (NCAs) databases in the EU. On the events front, Oviya MedSafe will be represented in two events which will be happening in short succession at Bangalore. I have been invited to speak on Medication Safety at IPSCON 2013, the 46th Annual Conference of the Indian Pharmacological Society to be held at Bangalore between 16th and 18th of December 2013, with pre-conference workshops on the 14th and 15th. I take this opportunity to invite you to this scientific feast which offers 13 symposia, 6 pre-conference workshops, 19 plenary lectures, 5 prize paper sessions, oral & poster sessions and exhibitions to the delegates. I believe that this conference will also provide a unique opportunity to network with eminent pharmacologists and researchers across academia and industry from around the world. As an Executive Committee Member of the Indian Society for Clinical Research (ISCR) and on behalf of the Local Organizing Committee of the 7th Annual ISCR Conference, I take great pleasure in inviting you to participate in the conference which is to be held on 10th and 11th January 2014 at Bangalore. This prestigious annual conference is expected to see high number of participants from the Clinical Research industry (CROs and Pharmaceutical companies), Academia, Regulators and other associated stakeholders. The 2 day-conference is planned so that latest updates on clinical research as well as the evolving regulations are discussed and deliberated by experienced and expert faculty from across India as well as invited speakers from outside India. Please click here for the details of the conference, including the scientific programme and the online registration system. I thank you for your patient reading and look forward to meeting you at Bangalore between 16th and 18th December 2013 and again on 10th and 11th January 2014.

Oviya MedSafe – London Exhibition & Indian Pharmacovigilance Updates 53 of 328


January 2014 Dear Colleagues, As all of us look forward to the beginning of 2014 with loads of enthusiasm and lots of expectations from the New Year, I take pleasure in wishing you and your families a very Happy and Propsperous New Year, on behalf of Oviya MedSafe, through this January 2014 edition of Oviya MedSafe's newsletter! We at Oviya MedSafe are exhilarated to start 2014 by announcing the enhanced continuation of our Bronze Partnership with Virtue Insight for their 6th Pharmacovigilance 2014 event at London on 4th and 5th March 2014, following our most recent association with them for the 5th Pharmacovigilance Congregation held at Mumbai on 20-Nov-2013. Being the first exhibition for Oviya MedSafe in Europe, this event is quite special to us. Along with the event organisers, we are happy to invite you to register for the event and visit us at our stall on these days.

A bunch of senior executives from Oviya MedSafe, including me, will be at London for the event and also intend to visit our existing as well as prospective clients present throughout the United Kingdom, over the next couple of weeks following the event. Please do let us know if you would like us to visit you at your office, with your preferred dates mentioned, so that we shall accordingly plan our travel and meet you for discussions on how we can help each other. Looking back at 2013, it seems to have been a significant year for Indian Pharmacovigilance, with quite a lot of milestones having been reported in the media. We at Oviya MedSafe have attempted to provide a timeline of these developments, for the awareness and benefit of all stakeholders of pharmacovigilance in India, as follows: 

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July 2013: According to the Indian Pharmacopoeia Commission (IPC), 150 new Adverse Drug Reaction (ADR) monitoring centres have been planned across the country by the end of 2014 to strengthen the Pharmacovigilance Programme of India (PvPI), which coordinated by IPC aims to attain its goal of setting up 350 ADR monitoring centres across the country by 2015, making PvPI the largest pharmacovigilance programme in the world. August 2013: According to the Drug Controller General of India (DCGI), drug packs will soon bear „rectangular box warnings‟, i.e., labels with details of adverse drug reactions. August 2013: The Government of India allocated INR 100 crores (One Billion Indian Rupees) for surveillance monitoring of not just drugs but also expanded the ambit of surveillance to cover blood, blood products, biologicals and medical devices. Efforts are also on to set up an anti microbial resistance monitoring cell. October 2013: The IPC created a Toll Free number (1800-180-3024) under the PvPI to collect suspected adverse drug reactions, which was launched by Mr Sten Olsson, Chief 54 of 328


WHO Programme Officer, World Health Organization - Uppsala Monitoring Centre (UMC), Sweden, who lauded the unique facility developed by the IPC. December 2013: Experts in the industry have recommended to the parliamentary standing committee on health and family welfare that examines the Central Drugs Administration (CDA) Bill to make pharmacovigilance mandatory in the proposed CDA Bill for continuous monitoring of ADRs. December 2013: The Government of Odisha, an Indian state, has requested the union health ministry to increase the funding for pharmacovigilance activities in Odisha, highlighting the beginning of the active participation of state governments of India in the PvPI. December 2013: WHO‟s UMC recognized India‟s concerted efforts in pharmacovigilance and stated that it was looking to make India a hub for pharmacovigilance training. It also observed that India needed to play a bigger role in the global landscape of ADR monitoring. The UMC also called for targeted and spontaneous monitoring for ADRs arising out of vaccination, especially with India being a global hub for manufacturing vaccines.

All of the above updates point towards the development and mainstreaming of pharmacovigilance as a concept in India, which is expected to eventually mandate pharmaceutical companies in India to strengthen their own pharmacovigilance departments and also sensitize practising doctors along with other healthcare professionals on their respective roles in making India as pharmacovigilant as possible. The proposed empowerment of the state governments of India aimed at closer monitoring of the PvPI across all states and the increasing emphasis on the Indian drug regulators from WHO-UMC and industry bodies alike to include adverse event information from pharmaceutical industry sources along with the voluntary reports received through the PvPI, while submitting the pharmacovigilance data of India to WHO-UMC periodically, are expected to be turning points for Indian Pharmacovigilance from various perspectives and 2014 is all set to witness these welcome changes. While treading on the topic of WHO-UMC, I am proud to recollect my first in-person meeting and long interaction with Mr Sten Olsson, WHO Programme Expert and head of the Global Outreach Department at the Uppsala Monitoring Centre, which happened at Bangalore during IPSCON 2013, the extremely well-organized 46th Annual Conference of the Indian Pharmacological Society, in which I had been invited to talk on Medication Safety. It was my honour that my talk just preceded Mr Sten Olsson's lecture on the same topic, which he obviously dealt with much more detail and exhaustive data. The conference also gave me an opportunity to listen to the Who's Who of Indian Pharmacovigilance as part of a panel discussion titled 'A Brainstorming on Aspiration and Vision for Pharmacovigilance in India'. Last but not the least, as an Executive Committee Member of the Indian Society for Clinical Research (ISCR) and on behalf of the Local Organizing Committee of the 7th Annual ISCR Conference, I take great pleasure in inviting you to participate in the conference which is to be held 55 of 328


on 10th and 11th January 2014 at Bangalore. This prestigious annual conference is expected to see high number of participants from the Clinical Research industry (CROs and Pharmaceutical companies), Academia, Regulators and other associated stakeholders. The 2 day-conference is planned so that latest updates on clinical research as well as the evolving regulations are discussed and deliberated by experienced and expert faculty from across India and aborad. Please click here for the details of the conference, including the scientific programme and the online registration system. I thank you for your patient reading and look forward to meeting you at Bangalore on 10th and 11th January 2014. Oviya MedSafe – UK Trip, UAE Visit, LRP Services & Indian Pharmacovigilance February 2014 Dear Colleagues, As Oviya MedSafe successfully glides into its third year of existence, I am gratified to reach out to you through the February 2014 edition of our newsletter and thank you on behalf of the company for your support which has helped us grow into a full-fledged provider of global Pharmacovigilance Consulting & Drug Safety services! Subsequent to the announcement we made in our last newsletter about our senior management members' forthcoming trip to London in March 2014, we received quite a lot of meeting invitations which we have accepted. Though we still have some slots left, we request our UK-based colleagues who are interested to meet us, to get in touch with us as soon as possible, so that we do not miss the opportunity to understand your pharmacovigilance service requirements. In case you are participating in the 6th Pharmacovigilance 2014 conference organized by Virtue Insight on March 4th and 5th, 2014 at Thistle Marble Arch Hotel in London, it will be the best place for us to meet, as Oviya MedSafe is a Bronze Partner for the conference. I take this opportunity to personally invite you to visit our Stall Number S5 at the conference, where we can spend some time together to understand each other's perspectives in Pharmacovigilance. On the way back from the UK, our senior executive team will visit the Dubai International Pharmaceuticals and Technologies Conference and Exhibition (DUPHAT) which will be held at the Dubai International Convention and Exhibition Centre in Dubai from March 10th to 12th, 2014. We hope to meet most of the important pharmaceutical companies and marketing authorization holders who have operations in the gulf region, at DUPHAT, which is the most recognized and significant pharmaceutical event in the Middle East. If you are based anywhere in the UAE and would like to meet us with business interests, kindly contact us in advance so that we can plan our meetings. 56 of 328


While on the topic of the services we offer, I am glad to specifically mention that in addition to the EU QPPV services which we started to provide quite some time ago, we have now gone further and launched Local Responsible Person (LRP or Local QPPV, as they are also known) services for all the European Union member states. As you know, Latvia, Portugal, Cyprus, Greece, Belgium, Bulgaria, Spain and Poland require LRPs to be appointed for all products, while Germany, France, Netherlands, Romania and Italy warrant LRP services if the concerned product is nationally approved and not centrally approved. In case you are in need of LRP services for any of these countries either separately or bundled with EU QPPV services, please do not hesitate to contact us for a reasonable and cost-effective proposal. And, coming to India, I am pleased to inform you that I am co-coordinating the conduct of a Continuing Medical Education Programme in Pharmacovigilance for Medical Practitioners, organized by the Indian Pharmacopoeia Commission (IPC), Ghaziabad – the National Coordination Centre (NCC) for the Pharmacovigilance Programme of India (PvPI), a Government of India initiative under the Ministry of Health & Family Welfare. The CME has been organized by the IPC in technical collaboration with the Indian Medical Association Tamil Nadu State Branch, on Saturday 22-Feb-2014 at Chennai, India. There are no registration charges to attend this programme, as it is fully sponsored by the IPC. With pharmacovigilance being my personal passion, it is my pride to play a key role in supporting this event on behalf of the Indian Medical Association, which is the largest professional association of doctors in India. For more information on this event and to register for participating in it free of cost, kindly click here. Our heartfelt thanks are due to Express Pharma, one of India's leading pharmaceutical industry magazines, which has featured this event on its portal. At this juncture, Oviya MedSafe commits to contribute in all possible ways to the strengthening of pharmacovigilance in India, especially by professionally consulting to and training Indian generic pharmaceutical companies in setting up their pharmacovigilance systems and mobilizing them to be compliant with global pharmacovigilance regulations. Last but not the least, I am glad to share with you that I have been recently inducted as an Associate Member of the Pharmaceutical Information & Pharmacovigilance Association (PIPA), UK. I consider this a great learning opportunity, as PIPA is one of the most vibrant pharmacovigilance associations in the world and I look forward to imbibing a lot of knowledge from my senior colleagues at PIPA. I am also happy to state that I have been elected as the Honorary Secretary of the Indian Medical Association, Coimbatore Branch (for 2015), through which position I aspire to more actively promote pharmacovigilance among doctors and emphasize on their responsibilities in patient safety. I thank you for your patient reading and look forward to meeting you at London and at Dubai in March 2014. 57 of 328


Oviya MedSafe – Second Anniversary, Pharmacovigilance Audits & DIA Conference March 2014 Dear Colleagues, It is our great pleasure to meet you through the March 2014 edition of Oviya MedSafe's newsletter, soon after our return from a successful trip to the United Kingdom to exhibit Oviya MedSafe's pharmacovigilance capabilities at the 6th Pharmacovigilance 2014 conference organized by Virtue Insight at London on March 4th and 5th. Our team also had the opportunity to visit DUPHAT 2014 - Dubai International Pharmaceuticals and Technologies Conference and Exhibition 2014, which was conducted at Dubai from March 10th to 12th, on our way back. We thank all our colleagues who visited us at our stall in the London conference and those who took the time to meet us at the Dubai exhibition. The two weeks of travel have taught Oviya MedSafe quite a lot about both these markets. As we venture into our third year of life with your heartfelt wishes, we are glad to share with you some of the moments of our enjoyment as a team, on account of Oviya MedSafe's Second Anniversary which was celebrated at Hotel Heritage Inn, Coimbatore on 23-Feb-2014. Please click here to view the pictures of the event. Kindly share your comments and likes. In this year, we aspire to strategically expand our drug safety operations through various modes to serve more and more clients across the globe by offering both end-to-end pharmacovigilance support and standalone drug safety services to pharmaceutical companies and other marketing authorization holders, as appropriate. We are proud to mention that an article titled "Gearing up for a Pharmacovigilance Audit Using a Risk Based Approach" which I authored with inputs from my colleagues Gayathri Subramani and Ganesan Ramakrishnan, has been published in the February 2014 edition of the popular pharmaceutical industry magazine Pharma Bio World. We are happy to share with you the article for online reading and for download in PDF format. We look forward to your feedback on the article which you can e-mail to us. We hope this article will be useful for all pharmaceutical companies in which the pharmacovigilance systems are evolving and in those whose systems need to be audited. As you might know, I recently co-ordinated the conduct of a Continuing Medical Education Programme in Pharmacovigilance for Medical Practitioners, organized by the Indian Pharmacopoeia Commission (IPC), Ghaziabad – the National Coordination Centre (NCC) for the Pharmacovigilance Programme of India (PvPI), a Government of India initiative under the Ministry 58 of 328


of Health & Family Welfare. The CME was organized by the IPC in technical collaboration with the Indian Medical Association Tamil Nadu State Branch, on Saturday 22-Feb-2014 at Chennai, India. The programme was quite successful and was reported in detail in popular pharmaceutical industry news portals Express Pharma and Pharmabiz. In fact, Pharmabiz did even a detailed preevent coverage of the programme. The photos clicked during the event can be viewed by clicking here. Please feel free to share your comments and thoughts on these photographs. Last but not the least, we would like to inform you that we will be in Mumbai for the "Conference on Pharmacovigilance & Drug Safety - A New Era" organized by the Drug Information Association (DIA) on March 21st and 22nd, 2014 at Sci-Tech Centre 7, Prabhatnagar, Jogeshwari (W), Mumbai 400 102. We consider this a great chance to network with colleagues from all over the world and are also keen to meet prospective clients at Mumbai interested to discuss business opportunities with Oviya MedSafe. Please contact us with your thoughts beforehand so that we can ensure that enough time is allotted for our scheduled meetings. We thank you for your patient reading and look forward to meeting you at Mumbai on 21st and 22nd March 2014.

Oviya MedSafe inks pact with PV247 Pharmacovigilance Software Database April 2014 Dear Colleagues, I am enthused to meet you and share with you some exciting news through the April 2014 edition of Oviya MedSafe's newsletter! Oviya MedSafe Pvt Ltd, India is glad to announce the establishment of its strategic relationship with Assured Information Systems Ltd, UK for usage of PV247, Assured‟s comprehensive regulatory-compliant Pharmacovigilance Software Database for managing the drug safety processes of Oviya MedSafe‟s clients. The term “Software Database Management” carries with itself a lot of apprehension, especially among the functional fraternity in the Pharmacovigilance sector. Oviya MedSafe intends to simplify this term for its clients by aligning with PV247, which has been catering to the pharmaceutical industry in Europe and USA since 1996. This alliance is the first of its kind in the Pharmacovigilance services sector in India and is aimed at promoting the adoption of pharmacovigilance systems among the pharmaceutical companies across the globe, banking on its cost effectiveness and user-friendliness. 59 of 328


PV247 is a flexible software system designed to support human and veterinary pharmacovigilance business processes and technical services, whilst meeting the associated company‟s safety as well as the worldwide regulatory reporting requirements. With this announcement, Oviya MedSafe reiterates its commitment to affordable, simplified yet reliable and end-to-end drug safety support to pharmaceutical companies of all sizes. At a time when India becomes the 7th largest contributor to Uppsala Monitoring Centre's international drug safety database and when the working group on drugs under the 12th Five Year Plan has proposed a funding of 9.64 Billion Indian Rupees towards upgrading the drug regulatory system in India, it is evident that the stage is set for the Indian pharmaceutical industry to move ahead towards achieving excellence in pharmacovigilance, for which the Oviya MedSafe-PV247 alliance will be a boon. Oviya MedSafe will be glad to answer your queries regarding this partnership and provide customized solutions for your pharmacovigilance obligations.

Oviya MedSafe – Local Literature Search & International Clinical Trials Day May 2014 Dear Colleagues, I am delighted to connect with you through this May 2014 edition of Oviya MedSafe's newsletter! Ever since we released our newsletter's April 2014 edition featuring Oviya MedSafe's strategic relationship with UK-based Assured Information Systems Ltd for usage of their Pharmacovigilance Software Database PV247 to manage the drug safety processes of our clients, we have been receiving lots of encouraging inquiries from prospective clients all over the world who truly believe that their problem of cost-effective pharmacovigilance regulatory compliance is now solved for good. We are excited that popular pharmaceutical industry media such as Express Pharma, Pharmabiz, Pharma Bio World, Pharmaceutical Online, The Pharma Times and many more have given due weightage to the news. Please contact me directly if you would like to know more details on how Oviya MedSafe and Assured Information Systems can together help you with your drug safety issues. I take this opportunity to highlight Oviya MedSafe's local literature search services, over and above the conventional global literature monitoring activities which are carried out by subscribing to known literature search databases like PubMed, MEDLINE or Embase. Every Marketing Authorization Holder (MAH) is mandated to regularly screen published medical and scientific 60 of 328


journals whether they are global or local, to ensure that any mention of their products is properly noted and reported to the competent authorities. It is not possible to produce a single list of local literature that covers all scenarios and products. There are many relevant local publications that are not included in any standard global literature search database such as the ones listed above. It is therefore advisable for a MAH to document their rationale for assuring that relevant local literature is included in their literature surveillance strategy. We at Oviya MedSafe are experienced in carrying out this activity on behalf of our clients and can broadly manage your literature screening requirements for all your products. Our weekly search is not only limited to identification of individual case safety reports, but also includes detection of potential safety issues. In addition, we carry out ad hoc literature searches for purposes of signal evaluation or for identifying safety concerns for inclusion in PSURs. While we have come to a time that the Indian mainstream media has started talking about adverse drug reactions in the postmarketing scenario, we need to appreciate the Pharmacovigilance Programme of India for generating this kind of awareness among all the stakeholders of Indian pharmacovigilance. It is evident that the Indian pharmaceutical industry would soon follow suit to fulfill the expectations the public have of it. Oviya MedSafe is determined to proactively support our colleagues in the industry with the highest standards of drug safety services, in line with global regulations. Before signing off, I am glad to wish you on account of the International Clinical Trials Day which falls on May 20th. On this day in 1747, Dr James Lind, a Scottish physician, conducted the first controlled clinical trial on a group of sailors suffering from scurvy. Through their participation in the study, the sailors contributed to the discovery that Vitamin C was an effective treatment for scurvy. As an Executive Committee Member of the Indian Society for Clinical Research (ISCR), it is my duty to share with you ISCR's guide for clinical trial participants titled "Patients First", which has been released on the eve of the International Clinical Trials Day. I request you to kindly re-share this document among your circles and thereby contribute in promoting the awareness of the need and the benefits of Clinical Research. Looking forward to meeting you in June 2014 with some more interesting news,

Oviya MedSafe – Expert Clinician Panel & UK Visit June 2014 61 of 328


Dear Colleagues, It gives me immense pleasure to meet you through this June 2014 edition of Oviya MedSafe's newsletter! As you know, Oviya MedSafe has been constantly growing its capabilities in Pharmacovigilance Consulting & Drug Safety Services, ever since its birth in 2012. At this juncture, I am glad to announce our next milestone which is the formation of our own Expert Clinician Panel. With Medicine being as vast and as deep as an ocean, we all know that it is not humanly possible for any single physician to keep themselves updated on every development across all specialties. If this task could be difficult for a practicing doctor, it is even more challenging for a pharmacovigilance physician who may not be an active practitioner. However, it is also to be recognized that Pharmacovigilance is by itself a medical specialty and it would be too much to expect a Drug Safety Physician to keep tabs with the advancements in day-to-say practice while continuously updating themselves with the changes in pharmacovigilance regulations across the globe. Oviya MedSafe proposes a novel solution to this challenge: our Expert Clinician Panel, which consists of well-qualified and widely experienced medical and surgical specialists in active practice. Our panelists are available to support our full-time pharmacovigilance physicians and drug safety associates, with any specific queries they may face while assessing adverse event reports. With the constitution of this panel, Oviya MedSafe is equipped to also provide the highest quality of specialist physician insights that may be required for any project relevant to Drug Safety and to the larger discipline of Patient Safety. Our city Coimbatore's reputation as a state-of-the-art healthcare destination and Oviya MedSafe's unparalleled comfort level with the experienced clinicians in the city have together resulted in this unique model for offering expert services in Pharmacovigilance, which is possibly the first of its kind in India. We are glad to mention that our first set of panelists include specialists in Endocrinology, Orthopedic Surgery, Traumatology, Gastroenterology, Obstetrics & Gynecology, Ophthalmology, Cardiology, Oncology, Nephrology, Urology and Radiology. Please feel free to contact me directly to know more about these specialized services. I also take this opportunity to share with you that I intend to visit the UK in July and would be glad to meet you to discuss any drug safety service requirements that you may have in general. Kindly let me know well in advance so that I will be able to structure my other meetings accordingly. Looking forward to reaching out to you in July 2014 with more exciting news, Oviya MedSafe – UK Subsidiary Incorporation, Pharmacovigilance Publication & UK Trip July 2014 62 of 328


Dear Colleagues, At a time when Oviya MedSafe attains a remarkable milestone, I am overwhelmed with joy to communicate it to you through the July 2014 edition of our newsletter. It is with great pleasure I announce that Oviya MedSafe has formalized its presence in the United Kingdom by incorporating its wholly owned UK subsidiary Oviya MedSafe UK Ltd on 02-July2014. We firmly believe that our newly formed UK company will help us better position ourselves in the European Union and, over the years, evolve as a hub from where we would expand our EU operations in the future. Though Oviya MedSafe has been offering EU QPPV and Local Responsible Person (Local QPPV / LRP) services for quite some time, we have always aspired to be a more active participant in the Pharmacovigilance arena in the EU, which has become a reality now. With EU playing a major role in the global pharmacovigilance scenario, it is imperative for us to be established in the region in order to achieve our vision of becoming a leader in the discipline. The passion for pharmacovigilance does not stop with me but is inculcated as a virtue among all the team members at Oviya MedSafe. As a proof of the claim, an article written by my colleagues Subash, Akash and Sumit, and titled Role Of Pharmacist Beyond Dispensing: A Pharmacovigilance Perspective has been published in Expressions 2014 – the annual magazine of Krupanidhi College of Pharmacy, Bengaluru, India and has been well-received by its readers. Please feel free to download the article by clicking on the title above and share your comments in reply. Before concluding, I am glad to let you know that I will be available in the UK between July 21st and August 7th, during which period I will be happy to meet you to discuss opportunities for us to work together. If you are interested, please contact me to identify mutually convenient time slots and locations for our meeting. I sincerely thank you for your support and encouragement which have motivated us to garner expertise, experience and excellence in our relentless journey of providing Pharmacovigilance Consulting and Drug Safety Services. Looking forward to meeting you in August 2014 with updates from my UK trip,

Oviya MedSafe – Europe Trip, Pharmaphorum Article & PV247 Webinar August 2014 Dear Colleagues,

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I am exhilarated to meet you all through this August 2014 edition of Oviya MedSafe‟s newsletter and share with you the news of the milestones we have attained of late, as well as indicate some of our plans for the future. To start with, my recent visit to Europe has made me realise that, as a brand, Oviya MedSafe already has a global reach, which has now been augmented and formalised, with the incorporation of our wholly owned UK subsidiary Oviya MedSafe UK Ltd in July 2014. In subsequence, we intend to grow and position our UK entity not only as the hub for our European expansion plans but also as the orthocentre of all our future international businesses, with our Indian parent company Oviya MedSafe Pvt Ltd retaining charge of our Indian operations. Thanks to leading UK-based global pharmaceutical industry magazine Pharmaphorum, which on 12-Aug-2014 published my article Incretin-based anti-diabetic therapies: a pharmacovigilance perspective, I have been able to bridge my medical specialty of Diabetology and my chosen profession of Pharmacovigilance, on an international platform for the first time. It is my pleasure to acknowledge the contributions of my Oviya MedSafe colleagues Gayathri, Kabila and Ganesan to this article. We, as Team Oviya MedSafe, request you to read the article by clicking on its title mentioned above and look forward to your feedback in reply. In April 2014, we announced Oviya MedSafe‟s partnership with UK-based software company Assured Information Systems to use and promote the use of their hosted pharmacovigilance software database PV247 in India and the overall Asia Pacific region. This alliance has been forged to pass on to the end client its benefit of cost-effectiveness without compromise on the need for a comprehensive solution. Meeting drug safety regulatory obligations often means that a pharmaceutical company must heavily invest upfront in setting up a pharmacovigilance department and system in their organisations. Our partnership enables such companies, especially generic drugmakers of any size and small & medium-sized innovators, to achieve a solution with a minimal budget and very less time. Ever since the collaboration with Assured was published, we have been receiving several inquiries about the capability and functionality of the PV247 hosted pharmacovigilance software database. To share this know-how with one and all, Oviya MedSafe, along with Assured, will facilitate a free one hour webinar session titled Assuring Cost Effective Global Pharmacovigilance Compliance. This webinar would include a free demonstration and has been tailored for pharmaceutical companies globally. Please confirm your interest in registering for this free webinar by contacting us with your name, designation, e-mail address and the name of your organisation. You will receive the confirmation of your registration and call-in details for the webinar subsequently. If you are unable to attend this webinar or would like more information on PV247, please visit www.pv247.com.

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Before I conclude, I also want to let you know that if anyone of you is interested to know more about Oviya MedSafe‟s capabilities and track record in pharmacovigilance, you are welcome to contact us to fix an exclusive webinar, during which I will personally walk you through the various services we offer in drug safety. Looking forward to meeting you all in September 2014 with more exciting news,

Oviya MedSafe – Pharmacovigilance Insights, PV247 Webinar Success & Conference Talks September 2014 Dear Colleagues, I am immensely happy to connect with you through this September 2014 edition of Oviya MedSafe‟s newsletter, which will not only update you about our organization but also provide you with useful insights on the recent advancements made in the domain of pharmacovigilance across the world, especially in India. As you know, Oviya MedSafe (in association with UK-based Assured Information Systems) organized a free webinar titled „Assuring Cost-Effective Global Pharmacovigilance Compliance‟ for pharmaceutical companies on 10-Sep-2014, which session included a complimentary demonstration of Assured Information Systems‟ human pharmacovigilance hosted software database PV247. The patronage for the webinar & demo session far exceeded our expectations and helped us realize that what we already offer at the moment is exactly the pharmacovigilance package that pharmaceutical companies would dream of, for the future: a comprehensive, reliable, economical, E2B & 21 CFR Part 11 compliant, user-friendly and global solution. It is my duty to thank leading pharmaceutical industry magazines Express Pharma and Pharmabiz for featuring the news about the event and our partnership for PV247 respectively. With our inboxes being filled with appreciations and requests for more information, we have begun to think that we should run such sessions periodically on a regular basis, for the benefit of those who missed our first event. I take this opportunity to thank all the attendees of the webinar & demo and look forward to your comments on it. In general, pharmacovigilance is now more in the news than it was ever before, not only in Europe in the background of the MHRA‟s WEB-RADR project to screen social media for drug safety information or the implementation of the EMA guideline on pharmacovigilance inspections, but also in countries like India. 65 of 328


The Pharmacovigilance Programme of India recently opened its doors to consumer reporting of drug adverse events, evolved for itself a guidance document in line with the WHO-NRA recommendation, and signed up with the National AIDS Control Organization to monitor the safety of the anti-retroviral drugs used, which are major breakthroughs for any country‟s national pharmacovigilance programme. At the same time, the mainstream media too seem to have come up with their best efforts to report incidents connected with suspected adverse drug reactions, follow-up stories on why other patients did not develop those adverse drug reactions, genuine educational attempts made by agencies such as the Maharashtra State Pharmacy Council to check drug-drug interactions by aiding pharmacists with software, „banned drugs‟ being available in India (visibly inspired by a much better researched and more complete article by Ms Gauri Kamath titled „Why India still sells medicines banned elsewhere in the world‟) and so on. All the above developments indicate that pharmacovigilance regulations specific for India (especially for marketed products) need to be drafted and enforced at the earliest in order for pharmaceutical companies operating in India to ensure compliance with the regulatory requirements in India which would also help them remain compliant with the regulations in the other markets in which they are present. This is probably the time for all the stakeholders of Indian pharmacovigilance to come together under a common forum and resolve these larger issues amicably. Before I conclude, I am glad to share with you the news about two conferences in which I will be speaking. The conferences organized by the OMICS group are co-located and will be conducted between 27-Oct-2014 and 29-Oct-2014 at Hyderabad International Convention Centre, Hyderabad, India. I have been requested to deliver one of the keynote addresses at the 3rd International Conference and Exhibition on Pharmacovigilance & Cinical Trials 2014 on the topic Hosted Pharmacovigilance Software Databases - The Emerging Solution. I will also talk on the topic Pharmacovigilance of Biosimilars - Challenges & Possible Solutions at the 3rd International Conference and Exhibition on Biowaivers, Biologics and Biosimilars 2014. I look forward to reaching out to you with more details soon. Looking forward to meeting you all in October 2014 with news of further interest,

Oviya MedSafe – DIA Conference, PIPA Publication & Hyderabad Talks October 2014 66 of 328


Dear Colleagues, I am delighted to reach out to you through this October 2014 edition of Oviya MedSafe’s newsletter, which I write from Mumbai where I am now to take part in the DIA 2014 9th Annual India Conference: The Future of Indian Health Care: Patients, Access and Innovation, between 16th and 18th October 2014. It is my great pleasure to catch up with pharmacovigilance colleagues and a learning experience to listen to the different perspectives of the attendees on various topics. The month of September 2014 saw Oviya MedSafe attaining yet another milestone: An article titled ‘The Role of Clinical Pharmacists in Pharmacovigilance: Some Thoughts From India’ authored by my colleagues Subash and Ganesan along with me, was published in the September 2014 edition (Issue 45) of PIPELINE – the Journal of the Pharmaceutical Information & Pharmacovigilance Association (PIPA), UK. Ever since the article got published, we have been receiving quite a lot of appreciation from the pharmacovigilance industry, fraternity of the pharmacology academia and the hospital-based healthcare professionals alike. PIPA members can read this article by clicking on http://www.pipaonline.org/Pipeline-Journal, after logging in to their online account. As indicated in our last month’s newsletter, I am glad to reiterate that I will be speaking in two colocated international conferences organized by the OMICS group at Hyderabad International Convention Centre, Hyderabad, India between 27-Oct-2014 and 29-Oct-2014. Of these, the 3rd International Conference and Exhibition on Pharmacovigilance & Cinical Trials 2014 will have me as one of the Keynote Speakers, with the title of my address being ‘Hosted Pharmacovigilance Software Databases – The Emerging Solution’. This will tentatively be the opening session of the conference starting at 09:00 hours IST on 27-Oct-2014. In the 3rd International Conference and Exhibition on Biowaivers, Biologics and Biosimilars 2014, I will talk on ‘Pharmacovigilance of Biosimilars – Challenges & Possible Solutions’. This session is tentatively scheduled at 14:40 hours IST on 29-Oct-2014. I hope I will be able to meet many friends from the industry and academia during these conferences. I am also keen to hear from you your thoughts on what you think should be covered in my talks on the above-mentioned topics, so that I can touch upon them in my presentations. Looking forward to connecting with you in November 2014 with more exciting news,

Oviya MedSafe – RoW Pharmacovigilance, PV247 Webinar & Conference Participations November 2014 67 of 328


Dear Colleagues, I am thrilled to connect with you through this November 2014 edition of Oviya MedSafe's newsletter, subsequent to my participation as a Keynote Speaker and a Chairperson in the '3rd International Conference and Exhibition on Pharmacovigilance & Cinical Trials 2014' and the '3rd International Conference and Exhibition on Biowaivers, Biologics and Biosimilars 2014' respectively, organized by the OMICS Group at Hyderabad, India. It was my honour to have shared the stage with renowned pharmacovigilance stalwarts Prof Dr K C Singhal, Mr John Barber and Dr Prakash V Diwan, among others, during the inaugural function of the Pharmacovigilance conference. My keynote address in the Pharmacovigilance conference 'Hosted Pharmacovigilance Software Databases - The Emerging Solution' and my talk in the Biosimilars conference 'Pharmacovigilance of Biosimilars: Challenges & Possible Solutions' were well-received. I am glad to roll out to you a few photographs of the event, with the permission of the organizers. Please click here to view the pictures and register your comments. I am proud to announce that Oviya MedSafe has launched comprehensive cost-effective pharmacovigilance service packages for the 'Rest of the World' (RoW) region. The term RoW region, traditionally meant to refer to the countries in the Asia Pacific, Latin American, Eastern Europe, African and Middle East regions, is a very important market for exporters of pharmaceutical products and medical devices globally, in terms of business expansion and revenue. The need for pharmacovigilance compliance in the RoW region assumes more significance as the demand for harmonisation and implementation of regulations is growing across all markets. Under these packages, in addition to offering outsourced drug safety support to pharmaceutical companies and marketing authorization holders, Oviya MedSafe will render pharmacovigilance consulting support to the regulatory agencies and the pharmaceutical industry in the RoW region. I would like to thank all the pharmaceutical industry magazines and portals which have patronized this news with great interest. Please click on the names of the respective magazines / portals to read the detailed news reports they published in this regard: Express Pharma, Pharma Asia, Pharmabiz and Life Science World. Oviya MedSafe's partnership with UK-based software company Assured Information Systems, to use and promote the use of their hosted pharmacovigilance software database PV247 in India and the overall Asia Pacific region, has come a long way since its beginning in April 2014. The first webinar that Oviya MedSafe and Assured Information Systems jointly organized on 10-Sep-2014 was well-attended and included a free demonstration of the PV247 system which sensitized the industry about the multiple benefits of adopting a robust hosted pharmacovigilance system while allaying the unreasonable fears linked to its perceived risks. 68 of 328


We understand that we would have to organize these webinars and demonstration sessions more frequently in order to clear our waiting list of requests for such sessions which have originated from our colleagues in the industry across the globe. In acceptance of these requests, Oviya MedSafe, along with Assured Information Systems, will facilitate a free one hour webinar session titled 'Assuring Cost Effective Global Pharmacovigilance Compliance' on Wednesday, 03-Dec-2014 from 3 PM to 4 PM Indian Standard Time (9:30 AM to 10:30 AM Greenwich Mean Time). This webinar would include a free demonstration of the PV247 system and has been tailored exclusively for pharmaceutical companies and marketing authorization holders located in India, Europe, CIS, MENA & APAC. Please confirm your interest in registering for this free webinar by sending an e-mail to register@oviyamedsafe.com with your name, designation, e-mail address and the name of your organisation. You will receive the confirmation of your registration and call-in details for the webinar subsequently. As you might already know, Oviya MedSafe is the Bronze Partner for the 7th Pharmacovigilance 2014 conference organized by Virtue Insight on Friday, November 21, 2014 at Kohinoor Continental Hotel, Mumbai, India. This is our third consecutive bronze partnership with Virtue Insight after our participation in their previous events in Mumbai in 2013 and London in early 2014. I take this opportunity to invite you to visit us at our stall in the conference. Before signing off, I am pleased to mention that the Indian Society for Clinical Research has planned to organize a Pharmacovigilance Symposium titled „Comprehensive Pharmacovigilance for India – The Road Ahead‟ in Peninsula Grand Hotel at Mumbai on 20-Dec-2014. I request you to keep a watch on ISCR website periodically for the detailed agenda and seek your active participation in large numbers to make this event a grand success.

Looking forward to writing to you in December 2014 with news of further interest,

Oviya MedSafe exhibits at DIA Conference in Washington, DC and announces USA expedition December 2014 Dear Colleagues, As we approach the Christmas holidays and prepare ourselves to welcome a fresh New Year, I take up the pleasurable task of connecting with you through this December 2014 edition of Oviya 69 of 328


MedSafe’s newsletter. For Oviya MedSafe, 2014 was a year of significant progress and we are objectively confident that 2015 will be our year of significant expansion. Before writing more, let me pause to wish you and your families ‘Merry Christmas’ and ‘Happy New Year’! First of all, I am exuberant to announce that Oviya MedSafe will be an exhibitor at the Drug Information Association’s Pharmacovigilance and Risk Management Strategies 2015 conference organized in Washington, DC, USA between January 26 and 28. With the North American market already being in our growth plan for early 2015, we at Oviya MedSafe see this as the best platform to proclaim our arrival. If you are attending this conference, please do visit us at Tabletop Number 16. Oviya MedSafe’s USA expedition will also include business visits along the East Coast, specifically the states of New York, New Jersey & Pennsylvania. If you would like to pre-fix face-to-face meetings with our team, please feel free to contact us with your interests. In case you live in the above-mentioned states and wish to work for Oviya MedSafe, kindly let us know in advance so that we can try to set up interviews for you with our team during our visit. On the home front, it is encouraging that a paradigm shift is happening in the drug regulatory system in India, with the CDSCO (Central Drugs Standard Control Organization) and the IPC (Indian Pharmacopoeia Commission) contemplating regulatory action following analysis of data collected through the PvPI (Pharmacovigilance Programme of India), thereby jointly committing to address the lacunae in the system. The IPC’s commendable efforts in forming a signal review panel involving industry experts have paid off, with the panel’s report convincing the IPC to recommend issuance of advisory notes or label changes for certain medicines. This positive development stands testimony to the growing industry-government collaboration in Pharmacovigilance in the country. The icing on the cake is that the Uppsala Monitoring Centre (UMC) has declared India to be the first country to report more than 100000 Individual Case Safety Reports (ICSRs) in VigiFlow and has agreed to train the PvPI staff on Signal Detection, as part of the deepening ties between the two organizations. As these intriguing changes take place in India, the Pharmacovigilance Working Group of the Indian Society for Clinical Research (ISCR) has organized a symposium titled ‘Comprehensive Pharmacovigilance for India – The Road Ahead‘, at the right time. The symposium, which comprises eminent speakers from the industry, academia, PvPI, ICMR, Indian Medical Association and the clinical investigator community, will be held at Peninsula Grand Hotel, Andheri (East), Mumbai on Saturday 20-DEC-2014, between 8:30 AM and 5 PM. I feel privileged that I have been requested to be a speaker in this symposium, for the session titled ‘The Emergence and Promise of Pharmacovigilance as an Outsourced Industry in India – Perspectives from Service Providers’. As this event brings together all stakeholders of pharmacovigilance on a single platform to discuss issues pertinent to India and jointly devise the way forward for the betterment of Indian 70 of 328


Pharmacovigilance, I personally believe it will be an excellent opportunity for all of us to listen to various perspectives from different stakeholders and also share our opinions on the subject. As an Executive Committee Member of ISCR, I appeal to the pharmacovigilance fraternity in India to register for this symposium in large numbers and make it a grand success, which is sure to instigate higher levels of collaborations among all the stakeholders of Indian Pharmacovigilance. Last but not the least, I wanted to share with you something that Oviya MedSafe is proud about: Our global headquarters Coimbatore which houses our global delivery centre, has been awarded India’s Best Emerging City at the India Today Best City Awards 2014. Apart from being declared the overall winner, Coimbatore has also scored the top rank among the emerging cities in the segments of Healthcare, Public Services, Transport and Investment. Subsequently, the Times of India too highlighted Coimbatore’s large pool of available talent and cost-effectiveness as its key advantages. I take this opportunity to invite you to visit Coimbatore and experience our zest and zeal, sometime soon! I sign off with a big thanks to you for reading this long letter and with assurance of more interesting updates from Oviya MedSafe in January 2015! Looking forward to meeting you at Mumbai & at Washington, DC,

Oviya MedSafe – Revamped Website, USA East Coast Pharmacovigilance Expedition & Mumbai Memories January 2015 Dear Colleagues, As we begin our journey into 2015, I am delighted to wish you all a very Happy & Prosperous New Year, through this January 2015 edition of Oviya MedSafe’s newsletter! We at Oviya MedSafe envision 2015 as a defining year for us and have already started working hard to achieve our selfset goals for this year. First and foremost, I would like to announce with a great deal of fulfilment, the launch of Oviya MedSafe’s revamped website on 15-Jan-2015. Please visit www.oviyamedsafe.com to view the new site. Of all the facilities available on the website, I am quite excited about the opportunities we now have to provide detailed notes on our pharmacovigilance consulting expertise, our drug safety services, an exclusive page on the services we offer through our partners, our own photo gallery, a section to showcase client testimonials and a dedicated downloads page from which our eBrochure and all publications from and/or involving Oviya MedSafe can be downloaded. Being a dynamic site, you can expect more and more of updates and improvements on a regular basis. Rather than writing anything more now, I would prefer to hear from you on what you feel about the new site. 71 of 328


As you might know, Oviya MedSafe is all set to exhibit at the Drug Information Association’s Pharmacovigilance and Risk Management Strategies 2015 conference organized in Washington, DC, USA between January 26 and 28. If you intend to attend this conference, I will be immensely happy to meet you at our Tabletop Number 16. Further, Oviya MedSafe’s East Coast USA expedition which was announced in our December 2014 newsletter has already become successful with quite a number of business meetings booked. In case you want us to meet you anytime within the forthcoming three weeks, please contact us at the earliest, as we have very few slots left. In case you live along the East Coast and wish to work for Oviya MedSafe, kindly let us know as soon as possible so that we may try to set up interviews for you either with me or my colleagues, during our visit. Last but not the least, I would like to sign off with memories from the symposium Comprehensive Pharmacovigilance for India – The Road Ahead, which was organized by the Pharmacovigilance Working Group of the Indian Society for Clinical Research in Mumbai on 20-Dec-2014, in which I was a speaker and also part of the organizing team. The symposium was reported by Pharmabiz. Here are some photos from the event. Looking forward to sharing more and more of exciting information in February 2015,

Oviya MedSafe – PIPA Fellowship, The Wall Street Journal and ISCR Pharmacovigilance Council February 2015 Dear Colleagues, With a great deal of optimistic enthusiasm, I take the pleasure of connecting with you through this February 2015 edition of Oviya MedSafe‟s newsletter! Quite a lot of development has brewed at our end during the first few weeks of 2015, about which I am happy to share with you today. Subsequent to the successful launch of Oviya MedSafe's revamped website which went on to get positive reviews from industry colleagues, our maiden initiative in the United States - a wellreceived Tabletop Exhibit at the DIA's Pharmacovigilance and Risk Management Strategies 2015 conference held at Washington DC between January 26 and 28, has added the next feather to our cap. Not only the exhibition at the conference, but Oviya MedSafe's East Coast USA expedition too was quite productive, in spite of the logistic hurdles posed by Winter Storm Juno. Our business meetings with prospective clients have refined our understanding of the pharmacovigilance service needs of the North American market and as a result, we have further streamlined our offerings to

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fulfil the drug safety obligations of pharmaceutical companies and biotechnology firms, in the North American region. Meanwhile, a quick look at the recent happenings in the pharmacovigilance scenario in India indicates that the voyage is in the right direction, with the need to sensitize physicians on ADRs to strengthen pharmacovigilance in India being highlighted by the Drug Controller General of India and with the proposal to identify more AMCs for access to WHO database through Vigiflow software as part of PvPI being mooted. It is worthy to note that the US FDA is now increasing its staff strength in India and is also inviting host-country regulators for its inspections to create more awareness about its ways. Personally, the New Year has been kind to me, as I have been showered with a string of recognitions starting with the award of the Fellowship of the Pharmaceutical Information and Pharmacovigilance Association (FPIPA), in line with the eligibility criteria set by PIPA as a professional accreditation association. While I am thrilled to be the first person hailing from India to receive this fellowship, I believe I owe a lot to my seniors in the industry on whose pedestal of achievement my statue of appreciation stands. The news about this recognition and my interview were published in several news portals such as Express Pharma, The Pharma Times, Pharmabiz, Life Science World, etc, whom I would like to thank at this juncture. Secondly, a mention of Oviya MedSafe and my comment on the growth of the Pharmacovigilance Outsourcing industry in India were made in the Wall Street Journal on 01-Feb-2015 in the article titled New Outsourcing Frontier in India: Monitoring Drug Safety, much to the acclaim of our wellwishers and peers. Last but not the least; I have been elected the Chair of the newly formed Pharmacovigilance Council of the Indian Society for Clinical Research, which was announced at the 8th Annual Conference of the association held at Gurgaon, India on February 13 and 14, 2015. While I accept this new responsibility, it is my privilege to reiterate my continuous commitment to the advancement of pharmacovigilance, which I am always passionate about. Before signing off, I would like to thank you for taking the time to read this newsletter edition and request you to share it with anybody whom you think may be interested in pharmacovigilance. Looking forward to meeting you through our March 2015 newsletter edition,

Oviya MedSafe – Third Anniversary, US FDA Safety Updates & Indian Pharmacovigilance Developments March 2015 73 of 328


Dear Colleagues, It is with absolute jubilation that I share with you this March 2015 edition of Oviya MedSafe‟s newsletter, in the background of our third anniversary celebrations! Looking back at Oviya MedSafe‟s humble beginnings in March 2012, I realize that we have indeed come a long way with our continual innovation and persistent efforts. Seizing this appropriate opportunity, I would like to thank you for your support and encouragement all through. I am overjoyed to see that my passion for Pharmacovigilance which instigated me to found Oviya MedSafe has percolated throughout the organization over the past three years and has, in fact, been recognized by our clients too. I am confident that, with all the goodwill, Oviya MedSafe will fly higher to attain greater altitudes in its chosen trajectory, in the years to come. Moving on to the current pharmacovigilance scenario in the United States, the past few weeks have been intriguing. The US FDA approved the first biosimilar product earlier this month. A biosimilar is not 'bio identical' to the approved biologic it references and therefore, could be associated with different adverse effects in consumers. Due to this fact, there have been differing views on how a biosimilar should be named. Adopting the non-proprietary name associated with the reference product and suffixing a short code to it to identify the manufacturer seems to be the most acceptable option, especially because it allows for easier pharmacovigilance reporting. It is expected that the US FDA would release its long-sought 'biosimilars labeling guidance document' sometime in 2015 and clarify on not only the acceptable nomenclature for biosimilars but also on their specific safety monitoring processes, if any. On the generics front, a debate on who should take the responsibility for label updates of generic medications is on. While there are pros and cons in entrusting this mandate either to the US FDA or to the industry in exclusivity, the trade groups for the generic and the brand-name drug makers have teamed to offer their own proposal for label changes. Interestingly, a recent report in The New York Times has claimed that most of the adverse event reports submitted to the US FDA database are incomplete, especially the demographic data. While this might have a bearing on the conclusions derived from the analysis of the submitted suspected adverse drug reaction reports, the news also provides justified reasons for all adverse event reports not having the complete data all the time. Coming back to India, a good deal of announcements made in the recent past hold a lot of promise for Indian Pharmacovigilance. The Drugs Technical Advisory Board (DTAB), which advises the Indian central and state governments on technical matters pertaining to drug regulations, has recommended mandating pharmaceutical companies to report adverse effects of marketed drugs. Further, DTAB re-insisted on its 2011 recommendation for pharmacovigilance cells managed by a trained medical officer or pharmacist to be set up in all pharmaceutical companies. It also emphasized on sensitizing medical practitioners across the country by involving the Medical Council of India (MCI) and on training medical representatives for collecting adverse event reports 74 of 328


from doctors. DTAB has called for setting up a panel to draft pharmacovigilance guidelines for India to streamline the participation of all stakeholders. Incidentally, Pharmabiz published Oviya MedSafe's comments on the lacunae in the Indian Periodic Safety Update Report (PSUR) submission and review process just before these announcements were made. Earlier, Pharmabiz had also published another of my interview on the US FDA's keenness to involve Indian regulators for their inspections to create awareness about its inspection activities in India. The Indian Health Ministry has approved a few days ago the „Materio Vigilance Programme of India‟ (MvPI) which would monitor Medical Device associated Adverse Events (MDAE) and be coordinated by the Indian Pharmacopoeia Commission (IPC) in collaboration with the Central Drug Standard Control Organisation (CDSCO). MvPI cells are to be established initially in 10 medical colleges in order to monitor the benefit-risk profile of medical devices. With these baby steps taken today towards achieving excellence in pharmacovigilance as well as materiovigilance in India, we can be confident that the country is marching in the right direction. Before signing off, I would like to specially thank pharmaceutical industry media Pharma Asia and Life Science World for featuring my accolades on the respective portals recently. Looking forward to connecting with you through our April 2015 newsletter edition,

Oviya MedSafe – UK bioConclave 2015, Pharmacovigilance in India and the Indian PSUR April 2015 Dear Colleagues, As the product of our ardour, prowess and endeavour over the past three years results in fruition, I pen in rejuvenation the April 2015 edition of Oviya MedSafe’s newsletter! Firstly, I am delighted to announce that Oviya MedSafe will participate in bioConclave 2015 , a conference to be held at London on 20-Apr-2015, organized with an intention to create closer collaborations between Indian and European Life Sciences companies. This gathering will bring together business leaders, policymakers, innovators, academics, entrepreneurs, investors and distributors on the same platform to exchange ideas, build relationships and forge future partnerships. If you plan to attend this event, please let us know so that we can ensure to meet up in person and discuss business synergies. Nextly, I was honored by leading Indian pharmaceutical industry magazine Chronicle Pharmabiz, which invited me to author a featured article titled Current Status of Pharmacovigilance in 75 of 328


India under its editorial on the same topic, both published in April 2015. This article traces the history of Indian Pharmacovigilance and presents its contemporary scenario in the background of the phenomenal growth of the global Pharmacovigilance outsourcing industry in India over the past eight years. The article also touches upon the significance of Pharmacovigilance as an applied specialty in Medical Practice and among the Academia as well. Moreover, it enlists the achievements of the Pharmacovigilance Programme of India (PvPI) and analyses the gaps in the Indian Pharmacovigilance System with suggestions on how it could be improved. While on the topic, it is worthy to mention that the Drug Controller General of India (DCGI) has planned to integrate the Periodic Safety Update Reports (PSURs) with PvPI, a decision that has been made during a meeting between both the organizations, held on 30th March 2015. Interestingly, my interview titled Oviya MedSafe calls for streamlining Indian PSUR submission & review process published by Pharmabiz on 5th March 2015 highlighted various issues with the Indian PSUR and suggested some changes, with one of them being the integration of the processes of submission of PSURs to the Central Drugs Standard Control Organization (CDSCO) and reporting of Individual Case Safety Reports (ICSRs) to PvPI. On the medical device vigilance side of things, with the Indian government planning to monitor adverse incidents reported with usage of medical devices, I am proud to mention that Oviya MedSafe is already prepared to offer the relevant Materiovigilance support not only for compliance with the MaterioVigilance Programme of India but also to fulfil any safety obligation of a medical device-maker for any market in question. With the expectation that the Indian Health Ministry would release 16 Billion Indian Rupees under the 12th 5-year-plan to the CDSCO for strengthening regulatory apparatus, the stakeholders hope for welcome changes to manifest in the Pharmacovigilance system in India. Looking forward to meeting you with more news in May 2015,

Oviya MedSafe – WHO VigiAccess, EU Pharmacovigilance Pearls & Indian Breakthroughs May 2015 Dear Colleagues, As a fellow pharmacovigilance aficionado, I believe our discipline has not seen a more promising month than the one that passed by. I wish to elucidate to you the reasons behind this optimism, in this May 2015 edition of Oviya MedSafe’s newsletter! First and foremost, we witnessed the World Health Organization (WHO) launch the VigiAccess website on 17-April-2015, with the aims of improving patient safety, increasing transparency and encouraging the reporting of adverse effects from medicinal products. VigiAccess is a web 76 of 328


application which could be used by anybody to access information on reported cases of adverse events associated with over 150000 medicines and vaccines. VigiAccess gives users access to statistical data from the more than 10 million cases reported from over 120 countries contained in VigiBase, the WHO database of suspected adverse reaction reports maintained by the Uppsala Monitoring Centre (UMC) in Sweden. To read more about the background and advantages of this phenomenal development, please click here. Moving on to Europe, it is important for us to note that the European Medicines Agency (EMA) has clarified on the pharmacovigilance reporting requirements for donated products that treat neglected conditions. According to the EMA, Marketing Authorisation Holders (MAHs) are required to report all suspected Adverse Drug Reactions (ADRs) occurring in the European Union (EU) or in third countries which are brought to their attention, which rule holds good for donated products too, as this data is relevant to the overall safety profile of a product. MAHs are also required to submit serious suspected ADRs from outside the EU to the EU’s pharmacovigilance database, EudraVigilance. Non-serious ADRs too are expected to be reported, but this could be done as a tabulated summary and submitted regularly. It might be worth recalling that the EU pharmacovigilance legislation in 2012 mandated the reporting of all suspected ADRs resulting from medication errors, with pharmaceutical companies and national regulatory agencies in the EU Member States being obliged to enter these adverse events in EudraVigilance. This obligation becomes more significant now, as the EMA, on behalf of the EU Regulatory Network, has released two draft good practice guides that aim to improve the reporting, evaluation and prevention of medication errors by regulatory authorities and pharmaceutical industry throughout the EU. I take this opportunity to appeal to you to please send your comments, if any, to the EMA well ahead of their deadline of 14-June-2015. Meanwhile, certain breakthroughs have happened in Indian Pharmacovigilance, which I was fortunate enough to be an active part of. The Indian Medical Association (IMA), India’s largest professional association of medical practitioners, has extended its support to the Pharmacovigilance Programme of India (PvPI) by offering to partner with PvPI technically and operationally through the IMA College of General Practitioners (IMA CGP), an academic wing of the IMA that caters to the professional development needs of the general practitioners across the country. During a meeting held between the PvPI officials and the representatives of IMA CGP in the presence of the Drug Controller General of India (DCGI), it was proposed that IMA CGP Headquarters at Chennai, India will be recognised as ‘PvPI Collaborating Centre for Safe Use of Medicines’. Kindly refer to the news reported on Pharmabiz and on Express Pharma for more information. Further, the PvPI officials along with representatives of the DCGI also had a round table meeting with pharmacovigilance experts from various global pharmaceutical companies, which I had the privilege of coordinating. The meeting was quite productive and its proceedings are expected to be published in due course. Please visit our photo gallery to view the pictures clicked during these meetings. 77 of 328


Last but not the least, I am proud to mention that an International Conference on ‘Roles and Responsibilities of Pharmacist in Chronic Disease Management, Adverse Drug Reactions and Therapeutic Drug Monitoring‘ was organized at Coimbatore (the city that houses our global delivery centre) by PSG College of Pharmacy with co-sponsorship from the Department of Science and Technology, Government of India, in which I was invited to speak on pharmacovigilance as a career for pharmacists and interact with the delegates as part of a panel of renowned doctors, hospital administrators and national & international speakers. Some pictures of this conference too are available on our photo gallery page mentioned above. Signing off for now, to meet you with more exciting developments in June 2015,

Oviya MedSafe – Tailored Multi-Regional Pharmacovigilance Support & European Conferences June 2015 Dear Colleagues, With the flowers of Pharmacovigilance blooming throughout the world, I wish to share their fragrance with you by handing this June 2015 bouquet of Oviya MedSafe’s newsletter! This universal season of enhanced awareness of Drug Safety began with the launch of the VigiAccess website (which I had detailed in Oviya MedSafe’s May 2015 newsletter) and warrants celebration with a song for sure! And, can there be a song more appropriate than ‘Take & Tell’ conceptualized by the Uppsala Monitoring Centre (UMC), to celebrate the science of Pharmacovigilance? I personally feel that, as evangelists of Patient Safety, all of us need to promote this ‘Take & Tell’ initiative and use it to motivate healthcare professionals and consumers to report suspected Adverse Drug Reactions (ADRs) to the relevant authorities. Despite the facts that pharmacovigilance is a global concept and that harmonisation of drug safety regulations is much talked about across the globe, the need for customized regulations for specific regions does exist with its own reasons. Nevertheless, many countries or groups of countries have adopted their regional guidelines from the Good Pharmacovigilance Practices (GVP), a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU), with varying levels of adaptations. The Middle East Asian and the African countries are of particular mention in this regard, as they have not only legislated the guidelines but have also implemented them quite some time ago. These guidelines cover all the available GVP modules with some amendments for national purposes. These guidelines could significantly influence pharmacovigilance practice in the 78 of 328


concerned regions and are expected to augment the adverse event reporting rates while enabling detection of signals from these parts of the world. We at Oviya MedSafe have had the privilege of working with clients from these regions over the past three years and completely understand the challenges faced by marketing authorization holders in complying with the new pharmacovigilance obligations. Accordingly, Oviya MedSafe has risen to the occasion by rendering cost-effective pharmacovigilance services with 21 CFR Part 11 & E2B compliant drug safety software database support. I am proud to mention that Oviya MedSafe’s offerings for these regions include assessment of the marketing authorisation holders’ pharmacovigilance obligations and execution of all the applicable drug safety tasks such as adverse event reporting (including electronic submissions where required), literature monitoring, aggregate reporting, risk management planning, signal detection and all other pertinent services. Speaking of regional pharmacovigilance compliance from an Indian perspective, an Office Order dated 18-May-2015 (effective from 01-Jun-2015) issued by the Indian Pharmacopoeia Commission (IPC), the National Coordination Centre for the Pharmacovigilance Programme of India (PvPI) under the Ministry of Health & Family Welfare, Government of India states that pharmaceutical companies need to submit ADRs due to their respective pharmaceutical products in XML-E2B format to PvPI to hasten the process of uploading Individual Case Safety Reports (ICSRs) to VigiFlow, a web- based database of UMC. This measure is expected to enhance the process of assessment of ADRs reported in India and facilitate the detection of signals from Indian data. While pharmaceutical companies in India do collect suspected ADR reports from healthcare professionals through their marketing teams, only a few of them have pharmacovigilance departments and drug safety software databases to generate ADR reports in XML-E2B format needed to comply with the Office Order. It is here that Oviya MedSafe emerges as the most reliable and comprehensive yet simple and economic solution for pharmaceutical companies to adhere to the Office Order. With Oviya MedSafe already being a pioneer in promoting Indiaspecific pharmacovigilance services such as authoring Periodic Safety Update Reports (PSURs) for submission to the Central Drugs Standard Control Organization (CDSCO) on behalf of our clients, the addition of XML-E2B ADR reporting support complements our portfolio of services in this vertical. I take this opportunity to thank pharmaceutical industry magazines PharmaAsia (Singapore), PharmiWeb (UK) and Express Pharma (India), for featuring the news of the introduction of our support services for pharmaceutical companies to report ADRs in XML-E2B format to PvPI. I also thank Pharmabiz for interviewing me and mentioning my comments in their news report on the Office Order. Further, I am pleased to inform you about my involvement in two forthcoming pharmacovigilance conferences, both of which are scheduled to be held at London, namely, the 4th International Conference and Exhibition on Pharmacovigilance & Clinical Trials to be conducted by OMICS 79 of 328


International and the UK Pharmacovigilance Day 2015 conference to be organized by EasyB, as an Organising Committee Member and as a Chair, respectively. OMICS International’s event in August 2015 will see Oviya MedSafe represented by reputed Pharmacovigilance Consultant and Oviya MedSafe’s UK Business Advisor Mr Alistair J Coates who will speak on the topic ‘European Pharmacovigilance under EudraVigilance and the eXtended Eudravigilance Medicinal Products Dictionary (XEVMPD) environment within it‘. I take the privilege of inviting you to register for the conference which is certain to serve the audience with a scientific feast in global drug safety. Last but not the least, I am delighted to state that I will be in the UK in October 2015 to chair EasyB’s event and conduct the day’s proceedings along with my good friend Dr Sumit Munjal, Medical Director Lead, Global Pharmacovigilance at Takeda Pharmaceuticals, UK. I will also participate in the 10th Annual Conference of the Pharmaceutical Information & Pharmacovigilance Association (PIPA), UK and hope to get the opportunity to meet drug safety colleagues from all over the European Union during these conferences. Signing off for now, to meet you with more engaging news in July 2015,

Oviya MedSafe’s Pharmacovigilance Event Diary 2015 – London, Mumbai & Singapore July 2015 Dear Colleagues, I am excited to connect with you through this July 2015 edition of Oviya MedSafe’s newsletter, which has been designed to be your ready reckoner of information on the global pharmacovigilance events that Team Oviya MedSafe will be a part of, in the months to come! At the 4th International Conference and Exhibition on Pharmacovigilance & Clinical Trials to be conducted by OMICS International at London, UK on the 10th, 11th and 12th of August 2015, Oviya MedSafe’s UK Business Advisor Mr Alistair J Coates will deliver a keynote address on the topic ‘European Pharmacovigilance under EudraVigilance and the eXtended Eudravigilance Medicinal Products Dictionary (XEVMPD) environment within it’. I am confident that the mention of this topic is by itself enough to make you think of attending this conference. On 2nd September 2015, we would look forward to meeting you at the 9th Pharmacovigilance 2015 conference that will be organized by Virtue Insight at Mumbai, India. Further, on 9th September 2015, Oviya MedSafe in association with Assured Information Systems, UK (part of Ennov Group) would conduct a webinar titled “Why pharmaceutical companies are in a dire need of building an innovative and efficient pharmacovigilance system for Indian compliance”, from 3 80 of 328


PM to 4 PM India Time (9:30 AM to 10:30 AM GMT). Please contact us directly for the agenda and the registration procedure for this free webinar. On October 19th 2015, I will chair EasyB’s UK Pharmacovigilance Day 2015 conference at London, UK and conduct the day’s proceedings along with Dr Sumit Munjal, Medical Director Lead, Global Pharmacovigilance at Takeda Pharmaceuticals, UK. I would also participate in the 10th Annual Conference of the Pharmaceutical Information & Pharmacovigilance Association (PIPA), UK and hope to get the opportunity to meet drug safety colleagues from all over the European Union during these conferences. In November 2015, I will be in Singapore to speak on ‘Exploiting Social Media to Identify Potential Safety Signals and to Augment Adverse Event Data Collection’ and be part of a panel discussion titled ‘Overcoming Challenges in PV in Developing Asia’, in the 6th Annual Pharmacovigilance Asia 2015 conference which has been organized by IQPC on 18th and 19th November 2015. I am proud to state that IQPC has invited Oviya MedSafe as an event partner for this conference. The Singapore event is further significant for Oviya MedSafe due to the fact that my colleagues and I will be presenting a post-conference workshop on 20-Nov-2015 titled ‘Case Narrative Writing for Reporting Adverse Events’, leveraging Oviya MedSafe’s rich experience in writing and reviewing various types of narratives for Individual Case Safety Reports (ICSRs) and Clinical Study Reports (CSRs). Please go through the event agenda and click here to register for the conference. I take this opportunity to request you to try your best to attend the above-mentioned events and join us in our aspiration to teach and learn from such knowledge-sharing occasions. Apart from the above, you may be able to meet us at some other events too, about which I will share in our newsletter’s August 2015 edition. Signing off for now, to meet you with more descriptive news next month,

Oviya MedSafe – Pharmacovigilance in Patient Safety Narratives for Clinical Study Reports August 2015 Dear Colleagues, As I prepare to fly to Mumbai for Virtue Insight’s 9th Pharmacovigilance 2015 conference, I am proud to spotlight a niche service of expertise that Oviya MedSafe has developed over the past year, through this August 2015 edition of Oviya MedSafe’s newsletter! The excellence of Oviya MedSafe’s featured offering, namely writing and performing quality review of Patient Safety Narratives for Clinical Study Reports, is a result of our relentless commitment to Oviya MedSafe’s core value of continuous capability-building coupled with the 81 of 328


organization’s experience-based learning derived by working with multiple global clients since 2012. As many of you would know, Patient Safety Narratives are comprehensive and clinically relevant chronological summaries of adverse events experienced by clinical trial subjects during or immediately following the clinical study in question. With Patient Safety Narratives playing a vital role in Clinical Study Reporting, it is of utmost importance that the narratives are written in compliance with the applicable regulatory requirements, for all phases of clinical studies, regardless of whether the subjects involved are healthy volunteers or patients suffering from a disease / condition that is being studied According to Section 12.3.2 of the ICH E3 Guideline (Structure & Content of Clinical Study Reports), brief narratives describing each death, each other serious adverse event, and those of the other significant adverse events that are judged to be of special interest because of clinical importance, need to be written. Events that are clearly unrelated to the test drug / investigational product may be omitted or described very briefly. The section further explains what a Patient Safety Narrative is expected to describe and what additional information should be included in the description. Whilst we are on the topic of narratives, it is appropriate for me to emphasize that Oviya MedSafe would conduct a post-conference workshop titled ‘Case Narrative Writing for Reporting Adverse Events’, at the 6th Annual Pharmacovigilance Asia 2015 conference organized by IQPC in November at Singapore, in which the focus areas would be Patient Safety Narratives for Clinical Study Reports and Case Narratives for Individual Case Safety Reports. I take pleasure in inviting you to join us for this conference at Singapore, in which I shall also deliver a lecture on ‘Exploiting Social Media to Identify Potential Safety Signals and to Augment Adverse Event Data Collection’ and participate in a panel discussion titled ‘Overcoming Challenges in PV in Developing Asia’. Please click here to download the agenda of this conference. Prior to the Singapore visit, I would travel to the UK in October to chair EasyB’s UK Pharmacovigilance Day 2015 conference which is to be held at London. I am delighted to share with you that the conference agenda is shaping up very well and the registrations are quite encouraging so far. My Co-Chair Dr Sumit Munjal, Medical Director Lead, Global Pharmacovigilance at Takeda Pharmaceuticals, UK and I are glad to invite you to be part of this interesting gathering which intends to take a closer look at unique areas in pharmacovigilance that are not often discussed in other events. During the same trip, I plan to attend the 10th Annual Conference of the Pharmaceutical Information & Pharmacovigilance Association (PIPA), UK too, where I hope to meet many of you. Moving on to Indian pharmacovigilance, I wanted to inform you that our webinar titled ‘Why pharmaceutical companies are in a dire need of building an innovative and efficient pharmacovigilance system for Indian compliance‘ announced in Oviya MedSafe’s July 2015 newsletter has been postponed to a later date, due to lots of happening changes in the Indian 82 of 328


drug regulatory system, which made us decide that holding the webinar after the regulations get crystallized would make it more unambiguous and engaging to the stakeholders. On another note, with India being a preferred pharmacovigilance outsourcing destination today, it is obvious that the time has come for the world’s second most populous country to realize its ambition of playing a key competitive role in the global pharmacovigilance scenario. Recognizing this emerging evolution, the 2nd National Pharmacovigilance Symposium of the Indian Society for Clinical Research (ISCR), rightly titled “Leveraging India’s Potential for the Advancement of Global Drug Safety”, has been organized at Bengaluru, India on Friday 25-Sep-2015, to which I invite you, in my personal capacity as the Chair of ISCR’s Pharmacovigilance Council, to participate in the day’s proceedings and also, if possible, to patronize this milestone event by sponsoring it. Last but not the least; I wish to let you know that we at Oviya MedSafe are looking for mid and senior level medically qualified pharmacovigilance professionals experienced in outsourced drug safety operations to join our team at our global delivery centre in Coimbatore and be part of Oviya MedSafe’s growth. If these criteria are applicable to you and if you are interested, please e-mail your CV with a covering letter to careers@oviyamedsafe.com so that our HR team could connect with you. Thanking you for the patient read and looking forward to writing to you again in end September 2015,

Oviya MedSafe – Social Media, Pharmacovigilance & the UK Parliament September 2015

Dear Well-wishers, With Oviya MedSafe’s invariable zeal for our undaunted dedication to the discipline of Pharmacovigilance, I take this delightful opportunity to share with you Oviya MedSafe’s September 2015 newsletter! There can be little disagreement on the statement that Social Media rule our lives today. The comfort of being able to instantaneously access multiple social networking portals and applications from our mobile telephones and tablet devices has indeed brought about a technology revolution amidst us over the past few years. With so many of us having already become social butterflies, it is natural that we are now quite open to sharing personal experiences, including unpleasant ones, on social sites as we would do amongst our real personal networks. This paradigm shift in our social behaviour comes as a boon to pharmacovigilance 83 of 328


enthusiasts across the globe that are constantly in pursuit of identifying more efficient means of mining quality adverse drug experience data. Although I am aware that much has been written about the role of social media in pharmacovigilance by several drug safety experts from different parts of the world, I accepted the invitation from Pharma Times, the official monthly newsmagazine and an indexed publication of the Indian Pharmaceutical Association, to author an article titled “Social Media as a Catalyst in the Advancement of Pharmacovigilance“ for their ‘Pharmacovigilance Special Issue‘ that was published in August 2015. With inputs from my colleagues, I have tried to cover in this essay the key global regulations, notable initiatives, advantages, challenges and possible solutions that are pertinent to leveraging the power of social media for deriving pharmacovigilance insights. This article is also available for download from our ‘downloads’ page. Your feedback on the content and the presentation would be welcomed and appreciated. While on the topic of social media and pharmacovigilance, it is relevant for me to invite you to the 6th Annual Pharmacovigilance Asia 2015 conference at Singapore, at which I will be speaking on “Exploiting Social Media to Identify Potential Safety Signals and to Augment Adverse Event Data Collection”. In the same conference, I will also be sharing my thoughts alongside my reputed co-panelists in the panel discussion “Overcoming Challenges in PV in Developing Asia”, from an Indian perspective. Further, my colleagues and I will be conducting a post-conference workshop titled “Case Narrative Writing for Reporting Adverse Events” at the conference. Please click here to download the complete agenda of the conference. Oviya MedSafe’s sessions in the conference have been aptly summarized on this page of the event website, which you may like to bookmark as a ready-reckoner. At this juncture, I wish to link you to two complimentary whitepapers “Emerging Tools for Data Collection: Social Media and Mobile Applications for Detecting Adverse Drug Reactions“ and “Snapshot of Asia’s Pharmacovigilance Standards and Practices“ offered by the organizers of 6th Annual Pharmacovigilance Asia 2015. I hope all these motivate you to join us at Singapore for the event. Kindly click here to register for the conference. Prior to this event at Singapore, my EU-based colleagues and I have planned a professional tour throughout the UK, starting with the PIPA Annual Conference 2015. Being a Chair of the UK Pharmacovigilance Day 2015 conference that is shaping up very well, I eagerly look forward to conducting the day’s proceedings and meeting my UK-based friends. Of special significance to me is the panel discussion on my favourite topic “Pharmacovigilance Outsourcing Trends, Predictions and Advantages – A SWOT Analysis“ which I would be moderating, with the renowned panelists being drawn from across the wide spectrum of stakeholders of pharmacovigilance outsourcing. As the seats for this conference are getting fast filled up, it would be advisable for the interested prospective delegates to register at the earliest by opting for any of the accepted methods of registration as detailed on this link. I would like to conclude this long letter with the pleasant announcement that I have been invited to deliver a speech on “South India – An attractive and emerging global pharmaceutical hub”, at 84 of 328


the UK South India Business Meet 2015, organized at the UK Parliament, London by the British South India Council of Commerce (BSICC) – a UK-based independent body that focuses on promoting trade and investment relations between UK and India, specifically South India. While this is a reflection of Oviya MedSafe’s well-recognized commitment and proficiency in the domain of pharmaceutical services, especially pharmacovigilance, it is my duty to thank the BSICC for showering this privilege on me. Obviously, my gratitude is always due to my colleagues at Oviya MedSafe whose enthusiastic teamwork has resulted in such laurels for the organization over the years. Waiting to meet you through our October 2015 newsletter,

Oviya MedSafe – UK South India Business Meet at the UK Parliament & Pharmacovigilance Conferences October 2015

Dear Well-wishers, With a great deal of felicity and immense optimism, I write this October 2015 edition of Oviya MedSafe’s newsletter, from London! Having spent most of October meeting several drug safety professionals in the UK, I realize that Oviya MedSafe as an organization is well-recognized in this part of the world too for our consistent commitment and continuous contribution to the discipline of pharmacovigilance. Participating in the PIPA Annual Conference 2015 and interacting with Medical Information & Pharmacovigilance industry colleagues from the UK as well as from some other parts of Europe affably imparted me with quite a lot of new learning, which I will treasure. UK Pharmacovigilance Day 2015, the conference which I chaired at London, was successful as expected and received very positive feedback. I had the opportunity to also moderate a panel discussion Pharmacovigilance Outsourcing Trends, Predictions and Advantages – A SWOT Analysis with eminent panelists, which was well-appreciated by the audience for its content and presentation. Please click here to view some photographs clicked during the event. My invited talk on the topic “South India – an attractive and emerging global pharmaceutical hub” at the forthcoming UK South India Business Meet 2015, which has been organized by the British South India Council of Commerce at the UK Parliament, is something that I look forward to. I trust the points I have to share on this topic will be relevant and considered by the concerned stakeholders. 85 of 328


Given the developments that India has rolled out a USD 275.21 million (INR 1800 crores) plan for overhauling the country’s drug regulatory system and that the UK Medicines and Healthcare products Regulatory Agency (MHRA) and India’s Central Drugs Standard Control Organisation (CDSCO) have signed a pact to increase collaboration between the two countries in the area of medicines and medical devices with the aim of further improving public safety, I believe this is the right time for fostering further collaboration between India and the UK in the domain of pharmaceutical services too, of which outsourced pharmacovigilance services form the lion’s share. At this juncture, I wish to profusely thank leading pharmaceutical industry news portals Life Science World and Pharmabiz for featuring news on my events in the UK. I am specifically grateful to News Today, a long-established English daily newspaper published in India, for having published my detailed interview in this regard. I also thank The Hindu, a renowned English daily newspaper, for reporting this news. Please click on the hyperlinked names of the news portals/newspapers to read the relevant media reports on their websites. Last but not the least, I take the pleasure of inviting you to Singapore for the 6th Annual Pharmacovigilance Asia 2015 conference, for which Oviya MedSafe is an event partner. Please click here for details of the three sessions in which my colleagues and I will be presenting on interesting topics both from global and Asia Pacific region-specific perspectives. Before signing off, I am glad to present to you a whitepaper titled The Top 5 Technologies Set to Transform Pharmacovigilance compiled by IQPC, the organizers of the 6th Annual Pharmacovigilance Asia 2015 conference at Singapore. Looking forward to connect with you through our November 2015 newsletter,

Oviya MedSafe – Asian Pharmacovigilance, Indian Emergence & European Compliance November 2015 Dear Well-wishers, I am enlivened to reflect upon the invigorating developments at Oviya MedSafe over the past month, while I attempt to capture its gist for this November 2015 edition of our newsletter! The engaging month began in an encouraging manner with my invited talk on the topic ‘South India – An Attractive and Emerging Global Pharmaceutical Hub‘ at the UK South India Business Meet 2015, which was organized by the British South India Council of Commerce (BSICC) at the UK Parliament, London on 05-Nov-2015. It was inspirational for me to share the dais at the prestigious venue, with Mr Virendra Sharma (UK Member of Parliament and Patron of BSICC who chaired the day’s proceedings) and with Dr Boora Narsaiah Goud (Member of Parliament, India who is also a renowned Laparoscopic & Gastrointestinal Surgeon), among other dignitaries. The 86 of 328


event was felicitated by UK Members of Parliament Mr Ranil Jayawardena and Ms Angela Rayner, who also interacted with the delegates. My talk was well-received and led to discussion on South India’s untapped potential in the pharmaceutical space, both from the manufacturing and from the services perspectives. Pictures of me at the event are available at this URL. To view the entire album containing the photographs of all speakers, click here. The formal report of this event can be accessed via this link. I take this opportunity to thank BSICC for awarding me the privilege of speaking at this august gathering and also for permitting me to share these images with my network. While I am glad about having been part of the UK South India Business Meet 2015, I regret that I missed the pride of taking part in WHO PV India 2015 – the 38th Annual Meeting of Representatives of National Pharmacovigilance Centres participating in the WHO Programme for International Drug Monitoring, which was hosted by the Indian Pharmacopoeia Commission (IPC), the National Coordination Centre of the Pharmacovigilance Programme of India (PvPI) from 4th to 6th November 2015 and inaugurated by Mr J P Nadda, Union Minister for Health & Family Welfare, Government of India. More than 150 international delegates from over 57 countries attended the meeting in which it was announced that the IPC is in the process of becoming the first WHO Collaborating Centre for Safety of Medicines and Vaccines in the South-East Asia Region. The proceedings of the meeting, which reiterate India’s commitment to pharmacovigilance, are available on this page. The commissioning of an advanced research centre at IPC in Ghaziabad (Uttar Pradesh, India) and references made to PvPI during the event may be taken as a testimony to India’s decisive approach to adopt better pharmacovigilance practices. The second half of the month, post the Deepavali holidays, was equally intriguing from a different angle though, as the 6th Annual Pharmacovigilance Asia 2015 conference at Singapore involved me in many sessions. My speech on ‘Exploiting Social Media to Identify Potential Safety Signals and to Augment Adverse Event Data Collection‘ along with the insights of my co-speakers set the ball rolling for brainstorming on what we could expect from various regulatory agencies in terms of regulations for mining social media for adverse events in the near future and also on key technology initiatives adopted by different organizations to improve reporting of adverse events. I was proud to mention that PvPI has already launched a mobile application for reporting suspected adverse drug reactions during this panel discussion and that the PvPI has agreed to collaborate with the Indian Medical Association to sensitize Indian doctors on the significance of reporting adverse events to the PvPI while sharing my opinion in another session about the recent developments in Indian pharmacovigilance. The post-conference workshop titled ‘Case Narrative Writing for Reporting Adverse Events‘ which I conducted along with my colleagues was quite impactful, as we could perceive from the audience at the end of the session. At the end of the conference, it was evident that Asia Pacific as a region is quickly catching up with the regulated markets in terms of pharmacovigilance regulations, as most of the deliberation coming from the reputed speakers in this region was on advanced subjects like Risk Management and Signal Management.

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Coming back to India, I am happy to let you all know that I have been honoured by an invitation to speak on the topic ‘What you need to have in Pharmacovigilance in order to market your products in the EU‘ at a seminar titled ‘Drug Development in Europe – Market Entry into Europe through Clinical Research‘ organized by Berlin-based Lumis International GmbH along with the Indo German Chamber of Commerce, for biopharmaceutical companies intending to conduct clinical research in Germany. At this event organized at Taj Vivanta MG Road in Bengaluru on 03Dec-2015, I will share with the audience Oviya MedSafe’s experiences in dealing with European Pharmacovigilance Requirements. If you are a pharmaceutical or biopharmaceutical manufacturer and are interested in attending this seminar, please click here to register. Registration is mandatory but free of cost. I hope to meet some of you at Bengaluru on 03-Dec2015. Thanking you for the patient reading and signing off now until we connect in end December 2015,

Oviya MedSafe – Bengaluru Pharmacovigilance Workshop & TiE Coimbatore’s d-Healthcare Event December 2015 Dear Well-wishers, After the merry celebrations of Christmas and while we wait to step into a New Year with the greatest degree of optimism, I am overjoyed to convey the Season’s Greetings to you and your families, through this December 2015 edition of Oviya MedSafe’s newsletter! Looking back at 2015 – a year that has been kind to Oviya MedSafe by ensuring that our untiring efforts have been duly rewarded, Team Oviya MedSafe is proud of our solid achievements during the year which have catapulted us to a much faster pace of anticipated growth in 2016. Our unique and pioneering combination of a global ‘boutique consultancy‘ approach coupled with the strength of our India-based operations has extraordinarily helped many clients in different parts of the world and has gone on to position Oviya MedSafe as an undeniable international player in the field of pharmacovigilance. I take this opportunity to specifically acknowledge and thank our clients without whose support we would not have succeeded to this extent. As you may already know, ‘perpetual capability building‘ is a core value of Oviya MedSafe. We believe that empowering the younger generation of pharmacovigilance professionals by sharing with them our knowledge and expertise is a fundamental tenet of our dedication to the discipline. As part of this commitment, Oviya MedSafe feels privileged to collaborate with the renowned Dr Darshan Bhatt to present a ‘One Day Workshop on Narrative Writing in Pharmacovigilance‘ that has been organized on Sunday 10-Jan-2016 at Hyatt Bangalore hotel in Bengaluru, India. The workshop, which aims to train aspiring pharmacovigilance professionals in the art of Narrative Writing in the right way, will be facilitated by Dr Darshan Bhatt and Ms Niharika Mathur. I will 88 of 328


retain the honor of introducing the workshop and speaking on the first topic titled ‘Why, what, and when of narratives‘. I am delighted to announce that Oviya MedSafe will issue certificates to the participants of this workshop. For more information on the program and the registration procedure, please click here. Oviya MedSafe’s January 2016 diary enlists something significant yet different for us, namely the d-Healthcare event that will be organized by TiE Coimbatore – the Coimbatore chapter of TiE Global, a non-profit, global community of and for entrepreneurs from all over the world. TiE was founded in 1992 by a group of successful entrepreneurs and is currently the world’s largest entrepreneurial organization. As a Coimbatore-headquartered global organization, Oviya MedSafe is proud to be invited to this first of its kind event. Thanks to the TiE Coimbatore leadership, I have been asked to chair a panel discussion titled ‘Opportunities in Healthcare Entrepreneurship‘, which I see as one of the key distinctions ever conferred on me as an entrepreneur. If you are an entrepreneur with your focus being anywhere in the larger healthcare space, this event is sure to be of help to you and I am glad to join TiE Coimbatore in welcoming you to register for this gathering. Before signing off, I wish you and your families a very Happy & Prosperous New Year 2016 once again, on behalf of Team Oviya MedSafe! Looking forward to meeting you through our January 2016 newsletter,

Oviya MedSafe supports MAHs with pharmacovigilance obligations related to EMA MLM January 2016 Dear Well-wishers, At the outset, I am delighted to wish you all a very happy and prosperous new year, through this January 2016 edition of Oviya MedSafe’s newsletter! The beginning of a year is obviously the best time to cherish the previous year’s achievements. For us, 2015 has been a year of qualitative and quantitative expansion during which Oviya MedSafe as a brand became much more recognized in the pharmacovigilance space across continents and also signed up with a considerable number of new clients from different parts of the world to provide end-to-end drug safety services. We saw this harvest in 2015, as a result of our consistent commitment to pharmacovigilance and our persistent hard work over the past four years. I take pleasure in passing on the due credit to my dedicated team of meticulous pharmacovigilance professionals. Of course, I need to thank our clients and business partners too for their cooperation, without which we wouldn’t have come this far so soon.

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In 2015, several innovative measures were adopted by different stakeholders of global pharmacovigilance with the intention of streamlining pharmacovigilance practices without compromising on patient safety. One of such ventures was the European Medicines Agency’s Medical Literature Monitoring Service (EMA MLM), which became fully operational from 1st September 2015. The service is in alignment with the guidance in Good Pharmacovigilance Practices (GVP) Module VI. As a component of this activity, EMA screens an aggregate of 400 active substance groups, including 300 chemical active substance groups and 100 herbal active substance groups. The EMA MLM service is being given as a support to the industry which, for the active substance groups and literature under the purview of the EMA activities, will not be obliged to enter the data on suspected adverse reactions into EudraVigilance. Individual Case Safety Reports (ICSRs) identified by the EMA MLM service are accessible to the Marketing Authorisation Holders (MAH) so they can incorporate them in their drug safety databases and meet their reporting commitments outside the European Economic Area (EEA). The MLM service thus becomes quite significant for the MAHs in the European Union (EU), especially the generic drug marketers, in many ways ranging from reduction of EU literature search liability to avoidance of duplicate efforts & reports. While it is true that EMA-MLM service reduces the literature search workload of the MAH, it must be remembered that the search covers only 400 products marketed in the EU. This essentially means that literature searches still have to be performed by MAHs in the following situations: 1) The MAH’s list of marketed products in the EU includes those which are not covered by MLM Service; 2) The MAH co-markets the product in other regions (especially the United States), which do not come under the purview of the MLM service; and 3) For identifying cases reporting the usage of products in special situations (pregnancy, lactation, etc) without an adverse event. Therefore, it is also right in a way to state that the MLM service identifies some opportunity for MAHs to outsource parts of literature search activities. On another note, some generic companies state that their ICSR volumes have increased following the commencement of MLM service. It is relevant to mention here that Oviya MedSafe, with the combined strengths of our Indian operations and our EU presence in letter and spirit, has mature processes and the best practices in place to support any client with our pharmacovigilance services pertaining to EMA’s MLM, including processing of the ICSRs (with electronic reporting to other regions, as appropriate) generated by the MLM service. Should you have any requirements, please feel free to contact us. Interestingly, the MLM service has become a hot topic of discussion in countries were pharmacovigilance obligations are emerging, since it is evident that literature cases contribute to a great extent to the volume of spontaneous cases. Adopting a system similar to the MLM service could be an effective way of identifying ADRs in countries were the market is dominated by drug 90 of 328


manufacturers or distributors who may not have enough resources to perform literature search. Hence, a model like MLM service could be of great advantage to a country that wishes to be pharmacovigilant, provided that it specifically intends to monitor adverse events reported via literature from its own regions in comparison and in contrast with the relevant global numbers. Although I would be happy to go on about EMA MLM and share my thoughts on it, I realize I have already written quite a lot and maybe it would be better if I re-visit this topic after a few months. Looking forward to connecting with you again through our February 2016 newsletter,

Oviya MedSafe supports MAHs with pharmacovigilance obligations related to EMA MLM January 2016 Dear Well-wishers, At the outset, I am delighted to wish you all a very happy and prosperous new year, through this January 2016 edition of Oviya MedSafe’s newsletter! The beginning of a year is obviously the best time to cherish the previous year’s achievements. For us, 2015 has been a year of qualitative and quantitative expansion during which Oviya MedSafe as a brand became much more recognized in the pharmacovigilance space across continents and also signed up with a considerable number of new clients from different parts of the world to provide end-to-end drug safety services. We saw this harvest in 2015, as a result of our consistent commitment to pharmacovigilance and our persistent hard work over the past four years. I take pleasure in passing on the due credit to my dedicated team of meticulous pharmacovigilance professionals. Of course, I need to thank our clients and business partners too for their cooperation, without which we wouldn’t have come this far so soon. In 2015, several innovative measures were adopted by different stakeholders of global pharmacovigilance with the intention of streamlining pharmacovigilance practices without compromising on patient safety. One of such ventures was the European Medicines Agency’s Medical Literature Monitoring Service (EMA MLM), which became fully operational from 1st September 2015. The service is in alignment with the guidance in Good Pharmacovigilance Practices (GVP) Module VI. As a component of this activity, EMA screens an aggregate of 400 active substance groups, including 300 chemical active substance groups and 100 herbal active substance groups. The EMA MLM service is being given as a support to the industry which, for the active substance groups and literature under the purview of the EMA activities, will not be obliged to enter the data on suspected adverse reactions into EudraVigilance. Individual Case Safety Reports (ICSRs) 91 of 328


identified by the EMA MLM service are accessible to the Marketing Authorisation Holders (MAH) so they can incorporate them in their drug safety databases and meet their reporting commitments outside the European Economic Area (EEA). The MLM service thus becomes quite significant for the MAHs in the European Union (EU), especially the generic drug marketers, in many ways ranging from reduction of EU literature search liability to avoidance of duplicate efforts & reports. While it is true that EMA-MLM service reduces the literature search workload of the MAH, it must be remembered that the search covers only 400 products marketed in the EU. This essentially means that literature searches still have to be performed by MAHs in the following situations: 1) The MAH’s list of marketed products in the EU includes those which are not covered by MLM Service; 2) The MAH co-markets the product in other regions (especially the United States), which do not come under the purview of the MLM service; and 3) For identifying cases reporting the usage of products in special situations (pregnancy, lactation, etc) without an adverse event. Therefore, it is also right in a way to state that the MLM service identifies some opportunity for MAHs to outsource parts of literature search activities. On another note, some generic companies state that their ICSR volumes have increased following the commencement of MLM service. It is relevant to mention here that Oviya MedSafe, with the combined strengths of our Indian operations and our EU presence in letter and spirit, has mature processes and the best practices in place to support any client with our pharmacovigilance services pertaining to EMA’s MLM, including processing of the ICSRs (with electronic reporting to other regions, as appropriate) generated by the MLM service. Should you have any requirements, please feel free to contact us. Interestingly, the MLM service has become a hot topic of discussion in countries were pharmacovigilance obligations are emerging, since it is evident that literature cases contribute to a great extent to the volume of spontaneous cases. Adopting a system similar to the MLM service could be an effective way of identifying ADRs in countries were the market is dominated by drug manufacturers or distributors who may not have enough resources to perform literature search. Hence, a model like MLM service could be of great advantage to a country that wishes to be pharmacovigilant, provided that it specifically intends to monitor adverse events reported via literature from its own regions in comparison and in contrast with the relevant global numbers. Although I would be happy to go on about EMA MLM and share my thoughts on it, I realize I have already written quite a lot and maybe it would be better if I re-visit this topic after a few months. Looking forward to connecting with you again through our February 2016 newsletter, Oviya MedSafe – XML-E2B Reporting of ICSRs by Industry to Pharmacovigilance Programme of India 92 of 328


February 2016 Dear Well-wishers, On this unique Leap Day, I am delighted to write for you this February 2016 edition of Oviya MedSafe’s newsletter, to elucidate on some developments in the Indian pharmacovigilance scenario, in the context of electronic reporting of Individual Case Safety Reports (ICSRs) in XMLE2B format by the pharmaceutical industry to the Pharmacovigilance Programme of India (PvPI). This topic gained prominence with the issue of an Office Order dated 18-May-2015 (effective from 01-Jun-2015) by the Indian Pharmacopoeia Commission (IPC), the National Coordination Centre for PvPI. The Office Order which was formally published on the website of India’s drug regulatory agency – the Central Drugs Standard Control Organization (CDSCO) and also sent to many pharmaceutical companies in the country, stated that the pharmaceutical industry needed to submit ADRs associated with their respective pharmaceutical products in XML-E2B format to PvPI to hasten the process of uploading ICSRs to VigiFlow, a web-based database of the Uppsala Monitoring Centre. This measure was expected to enhance the process of assessment and signal detection. Ever since this Office Order was issued, it became a subject of intense deliberation among drug manufacturers and importers/distributors. Many pharmacovigilance professionals welcomed the move and heralded this announcement as an assertive and crucial step towards an integrated pharmacovigilance system for India. The Office Order did result in all types of pharmaceutical companies in India focusing more on pharmacovigilance and coordinating with their marketing teams to collect suspected ADR reports from medical practitioners. But, this improvement was not without its practical challenges, as the pharmaceutical industry in India had been reporting ADRs only in CIOMS format to the CDSCO in person until then and was not entirely ready for this digital upgrade. The Office Order did not imply much difficulty for large Indian pharmaceutical companies that were already selling their products in regulated markets, as they had invested long ago in pharmacovigilance professionals and drug safety software databases for their global compliance. However, it was indeed a challenge for smaller drug manufacturers and importers/distributors that did not have a pharmacovigilance system in place to comply with the new requirement. It was at that point which we at Oviya MedSafe committed to make a difference and rolled out allinclusive support services for pharmaceutical companies impacted by the Office Order. With Oviya MedSafe’s expertise in global pharmacovigilance consulting and our experience of delivering drug safety services to comply with the regulations of different countries, we identified novel ways to render functional pharmacovigilance support coupled with the deployment of our 21 CFR Part 11 & E2B compliant drug safety software database. This combination resulted in a reliable and comprehensive yet simple and cost-effective solution for any pharmaceutical company in India to adhere to the Office Order. Since Oviya MedSafe, by then, had already been 93 of 328


recognized as a pioneer in providing India-specific pharmacovigilance services including but not limited to authoring PSURs for submission to CDSCO, adding XML-E2B format ADR reporting activities completed and complemented our portfolio of offerings for Indian pharmacovigilance compliance. Although Oviya MedSafe has been working with many Indian pharmaceutical companies over the past 4 years, the necessity of an efficient ICSR management team and a regulatory-compliant drug safety database to comply with the Office Order has resulted in Oviya MedSafe seeing a significant rise in the number of clients approaching us for our services for Indian compliance after the issue of this Office Order. We at Oviya MedSafe are quite proud of being able to carry out end-to-end Indian pharmacovigilance compliance activities for our clients irrespective of whether they are Indian or foreign companies. We firmly believe that the future for the safety of Indian patients is brighter than ever before, thanks to this appreciable initiative of the PvPI, and find ourselves honoured to be part of it. Having spoken so much about Indian Pharmacovigilance, it is quite appropriate at this time for me to announce a dedicated colloquium for brainstorming on the pharmacovigilance issues faced by Indian-headquartered pharmaceutical companies for compliance with the drug safety regulations of Indian as well as the well-regulated markets: Indian Pharmacovigilance Day 2016, a one-day conference to be organized by Italy-based EasyB srl, at Mumbai, India on Friday, 22-July-2016. EasyB is renowned throughout Europe for the Pharmacovigilance Day series of events which they had been conducting in several European countries over the past two years. I take this opportunity to thank EasyB for designating me as the Chair of the first Indian Pharmacovigilance Day and assure you that more information about this event will be revealed in due course. Before I sign off, I wish to announce, with all gratefulness to EasyB, that I have been invited by them to Chair their UK Pharmacovigilance Day 2016 conference to be held at London on Tuesday 18-Oct-2016 following the success of the first UK Pharmacovigilance Day in 2015 which too I had chaired. Looking forward to meeting you through our March 2016 edition with some more snippets,

Oviya MedSafe – UK FPM Article, Indian Pharmacovigilance Legislation & DIA Speakership March 2016 Dear Well-wishers, As we get back to work after our Easter breaks, I feel rejuvenated to articulate my thoughts to compose this March 2016 edition of Oviya MedSafe’s newsletter focusing on a significant Indian development of international interest!

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It was a moment of pride when the Faculty of Pharmaceutical Medicine (FPM) of the Royal Colleges of Physicians of the United Kingdom invited me to share my perspectives on the evolution of pharmacovigilance in India. The obviously daunting exercise warranted a good deal of hard work, which I put in with the help of my colleague Dr Vignesh Rajendran. The result was a comprehensive article titled ‘Pharmacovigilance in India – The Past, Present and Future‘ elaborating on the advancements the country has seen in various aspects of the discipline and emphasizing the scope for leveraging the benefits of synergy among all the relevant stakeholders such as pharmaceutical companies, professional bodies, pharmacovigilance service-providers, healthcare professionals, consumers, regulators, the national pharmacovigilance programme, etc. The article has been published in FPM’s Spring 2016 Newsletter – a special issue on pharmacovigilance released on 30-Mar-2016 and is accessible through this link. I hope you will find this article informative and am keen to hear your feedback. Interestingly, the article happens to be the first independent report of a key revolution that has happened in the history of pharmacovigilance in India, namely the Government of India mandating pharmacovigilance as a legal obligation for the pharmaceutical industry. The Gazette of India vide notification number GSR 287(E) dated 08-Mar-2016 necessitates applicants (drug manufacturers/marketers) to have a pharmacovigilance system in place and also hints at the qualification & training requirements for the personnel managing the system. This document is available on the website of Central Drugs Standard Control Organization (CDSCO – India’s Drug Regulatory Agency) in their Notification/Circulars/Publications section. Please scroll down to the last two pages of the PDF document to read the English version of the gazette notification. The impact of this gazette notification could be better interpreted in conjunction with the Office Order dated 18-May-2015 requesting the pharmaceutical industry to submit ICSRs in XML-E2B format to the Pharmacovigilance Programme of India (PvPI), which was discussed in detail in Oviya MedSafe’s February 2016 newsletter. At this juncture, it is pertinent for me to state that Oviya MedSafe, which has already been contracted by several pharmaceutical companies for their Indian as well as global compliance, has well-established structure and systems to comply with the growing pharmacovigilance obligations in India, which may benefit you too. India’s rising prominence in the international pharmacovigilance arena and the growing significance of technology-driven initiatives in patient safety management call for intense interaction among drug safety professionals from across the globe, which has been duly facilitated by the Drug Information Association (DIA) by organizing a conference titled ‘Innovations in Pharmacovigilance – the era of e-PV‘ at Mumbai, India on 13th & 14th May 2016. I owe my thanks to DIA for inviting me to join the Program Committee of the conference and play an active role in chiselling the event agenda along with some of my colleagues of repute in the industry. I have also been requested to moderate a session titled ‘Destination India – PV Outsourcing‘, which I am quite enthusiastically working on. Speaking of conferences, it is my duty to also emphasize the Indian Pharmacovigilance Day 2016 and UK Pharmacovigilance Day 2016 conferences, which are to be chaired by me. The Indian Pharmacovigilance Day conference is to be organized for the first time on Friday 22-July-2016 at 95 of 328


Mumbai, in follow up to the Pharmacovigilance Day series of events conducted in different parts of Europe. The conference is being conceptualized to be unique in its own way and the registrations are expected to be opened up in due course. The UK Pharmacovigilance Day 2016 conference is scheduled to be held on 18-Oct-2016 at London for the second time, following the success of UK Pharmacovigilance Day 2015 which too was chaired by me. It will be my pleasure to meet you at these conferences on which I intend to share more information in the forthcoming newsletters. Looking forward to meeting you through our April 2016 newsletter with a different set of thoughts,

Oviya MedSafe excels in Pharmacovigilance of Patient Support Programmes & Market Research Programmes April 2016 Dear Well-wishers, I eagerly write for you this April 2016 edition of Oviya MedSafe’s newsletter which aspires to provide an overview of the relevance of Pharmacovigilance in Patient Support Programmes and Market Research Programmes, with emphasis on the capabilities and experience of Oviya MedSafe in this niche super-specialty segment within the larger discipline of Drug Safety. The Guidance Notes for Patient Safety and Pharmacovigilance in Patient Support Programmes released by the Association of the British Pharmaceutical Industry (ABPI) on 09May-2011 (which is now being revised in light of the new pharmacovigilance legislation) states that a Patient Support Programme (PSP) is a service for direct patient or patient-carer interaction/engagement designed to help management of medication and/or disease outcomes or to provide healthcare professionals with support for their patients. Section VI.C.2.2.11 of the Good Pharmacovigilance Practices (GVP) Module VI (Revision 1, 08-Sep-2014) defines a PSP as an organised system where a Marketing Authorisation Holder (MAH) receives and collects information relating to the use of its medicinal products. According to section VI.C.2.2.11 of the GVP, a Market Research Programme (MRP) is defined as a systematic collection, recording and analysis by a MAH of data and findings about its medicinal products, relevant for marketing and business development. While both PSPs and MRPs are not formal studies driven by structured protocols and may not always be product-specific, the main difference between a MRP and a PSP is that a MRP does not usually take interest on the individual identities of the respondents which is not the case with a PSP. Further, although follow-up may be possible in a MRP, consent to follow-up is not explicitly sought for or provided as a routine. It could be much more challenging in a MRP rather than a PSP to medically confirm a reported 96 of 328


adverse event. A MRP can be classified as Qualitative or Quantitative and also as Primary or Secondary. PSPs are rolled out by MAHs with the prime motive of helping patients and/or Healthcare Professionals (HCPs) better manage disease and optimize treatment. Identifying adverse events is not an objective of PSPs and in fact, PSPs are usually not designed to be organised data collection schemes. However, it is crucial that Patient Safety is a priority in PSPs and the MAH should be able to meet ethical, legal and regulatory obligations including pharmacovigilance requirements. According to a presentation on the European Medicines Agency’s (EMA) website, the objectives of most PSPs fall under one of the below-mentioned three categories: To support patients and help them take their medications as prescribed (compliance/adherence); To help patients understand their condition and provide advice on managing disease, such as lifestyle (exercise or diet) & disease education; and To provide a service or financial assistance or reimbursement support for patients (which are also known as patient assistance programs). Adverse event reports identified from PSPs and MRPs should generally be considered as Solicited Reports (with some exceptions as explained in GVP Module VI.B.1.2). To manage information on suspected Adverse Drug Reactions (ADRs) identified from PSPs and MRPs, MAHs should have the same mechanisms in place as for all other solicited reports (as detailed in GVP Module VI.C.2.2.2). Valid Individual Case Safety Reports (ICSRs) should be reported as solicited reports in accordance with the electronic reporting requirements provided in GVP Module VI.C.6.2.3.7. Due to this reason, it is important for the MAH to seek the reporter’s causality assessment. If the reporter’s causality is missing, the MAH is obliged to provide their own causality assessment. The United States Food & Drug Administration (US FDA) too states in its Compliance Program Guidance Manual (Chapter 53 – Section D.1.b and Section G) that adverse event reports originating from PSPs should be handled as safety information obtained from a postmarketing study. The Pharmaceutical Information & Pharmacovigilance Association (PIPA), in a presentation on its website, clarifies that reporting of suspected ADRs in the form of ICSRs is not required if such information is identified during secondary review of data previously collected from consumers or HCPs for other purposes (secondary data). However, such information should be summarised as part of any interim safety analysis and in the final study report unless the protocol provides for different reporting. PIPA emphasizes that MAHs should have a structured contract with PSP vendors who must be trained in identifying adverse events and reporting them. If a Safety Data Exchange Agreement (SDEA) is in place, all the parties to the agreement must be made aware of their adverse event reporting obligations in the context of the concerned PSP. The common inspection findings pertaining to pharmacovigilance of PSPs include failing to report suspected 97 of 328


ADRs, lack of awareness of the pharmacovigilance team and/or the Qualified Person for Pharmacovigilance (QPPV) of PSPs, lack of or inadequate agreements with PSP vendors, failure to train vendors, lack of reconciliation activities and lack of audits or other monitoring methods. Hence, it is vital on the part of the MAH to ensure that such obvious misses are avoided when PSPs are conceived and/or executed. We at Oviya MedSafe are well-positioned in terms of our expertise and track record in managing safety data derived from PSPs and MRPs. Right from helping a MAH in putting together a pharmacovigilance plan for a prospective PSP/MRP to analyzing and/or performing quality checks of data collated from a PSP or MRP with the target of screening the data for adverse events, Oviya MedSafe can take care of all the pharmacovigilance obligations a MAH is expected to fulfil, on behalf of the MAH. Needless to mention, we will be able to leverage our ICSR-processing services coupled with our 21 CFR Part 11 & E2B compliant drug safety software database support, as required, to electronically report suspected ADRs to the competent authorities. It will be our pleasure to support you with any such business needs you may have at the moment or foresee in future. I wish to share some recent updates on the vibrantly progressing pharmacovigilance scenario in India, further to what I had elucidated in Oviya MedSafe’s March 2016 newsletter. I was privileged to be invited to speak at the 5th Anniversary Celebrations of the Indian Pharmacopoeia Commission’s commitment as the National Coordination Centre for the Pharmacovigilance Programme of India (PvPI) on 14-Apr-2016 at New Delhi on the topic ‘Industry Engagement in PvPI’, during which I put forward my suggestions on how the pharmaceutical industry could work with the PvPI for further advancements to come through in Indian Pharmacovigilance. The significant outcomes of the meeting were a proposal of the Government of India to make PvPI an autonomous Centre of Excellence and the formal launch of the Medical Device Adverse Event Reporting (MDAE) Form for the Materiovigilance Programme of India (MvPI). I also had the opportunity to participate in the 2nd Interactive Session on Challenges and Issues in ADRs reporting by Pharmaceuticals Industries to PvPI organized by PvPI on 29-April-2016 at IPC, Ghaziabad. The well-promoted meeting which brought together members from the industry, PvPI and the Central Drugs Standard Control Organization (CDSCO) resulted in a call for an Indiaspecific ‘Good Pharmacovigilance Practices’ guidance document for the industry. Given these developments, it is obvious that the task of integrating and streamlining the opinions and expectations of all stakeholders of Indian pharmacovigilance assumes significant relevance. I am glad to announce that the forthcoming Indian Pharmacovigilance Day 2016 conference to be organized at Mumbai on 29-July-2016 by Italy-based EasyB srl, who are well-known for their Pharmacovigilance Day series of events in Europe, is tailored towards addressing this pressing need of the domain in India. I am proud that I would be chairing this conference which will have expert speakers from the industry, health authorities, research bodies, academia and healthcare delivery centres. The conference is now open for registration and I take this opportunity to solicit your active participation to make it a grand success. 98 of 328


While on the topic of conferences, I would like to gently remind you to register for the fastapproaching DIA conference ‘Innovations in Pharmacovigilance – the era of e-PV‘ which is to be held at Mumbai on 13th & 14th May 2016, if you have not already. As a member of the Program Committee, I feel that the final agenda of the conference has come out quite well and I am particularly thrilled to be moderating a panel discussion titled ‘Destination India – PV Outsourcing’ on 14-May-2016 between 14:45 and 15:30 hours, with my esteemed colleagues from other pharmacovigilance service-providers as panellists. I look forward to meeting many of you at these forthcoming events. Signing off now to meet you later through our May 2016 newsletter,

Oviya MedSafe – DIA Experience, Article with PvPI & Indian Pharmacovigilance Day 2016 May 2016 Dear Well-wishers, I take immense pleasure in reaching out to you through this May 2016 edition of Oviya MedSafe’s newsletter which synopsizes our contemporary active involvement in a range of initiatives, of course within our beloved pharmacovigilance domain! The first half of May 2016 was indeed invigorating with a great sense of responsibility on my shoulders as a Program Committee Member of the DIA conference ‘Innovations in Pharmacovigilance – the era of e-PV‘, especially as the Moderator of the panel discussion titled ‘Destination India – Pharmacovigilance Outsourcing‘ with eminent colleagues from the industry as panelists. I also had the opportunity to provide my insights on the overall agenda of the conference, which were well-received by my fellow members in the Program Committee, the Conference Chair, the Conference Vice Chair and staff of DIA India. The conference was a grand success and I personally received appreciations from many of the professionals in the audience. Please click here to watch my brief video interview recorded during the conference. This DIA conference was an eye-opener for me to comprehend the far & wide reach of brand Oviya MedSafe and realize the trust placed on us by our colleagues in the pharmaceutical and the CRO industries not only in India but outside the country too. Specifically, the acclaim that many of the delegates had for our monthly newsletters, especially the April 2016 edition titled ‘Oviya MedSafe excels in Pharmacovigilance of Patient Support Programmes & Market Research Programmes‘ was of tremendous gratification to our passionate commitment to pharmacovigilance beyond business. Although the habit of publishing papers is not new to me or my colleagues at Oviya MedSafe, it was one of my greatest honours to have co-authored an article titled ‘Pharmacovigilantes in the Pharmacovigilance Programme of India (PvPI): Ideal Qualities and Skills‘ with Dr G N Singh (Drug 99 of 328


Controller General of India), Dr V Kalaiselvan (Principal Scientific Officer, Indian Pharmacopoeia Commission) and Dr Thota Prasad (Scientific Assistant, Indian Pharmacopoeia Commission). This article was published in the April 2016 edition of the Journal of Young Pharmacists and the fulltext-PDF is available for download from the title link above. I wish to thank PvPI for having given me this prestigious opportunity and look forward to hearing your feedback on the article. While speaking of PvPI, it is relevant to mention that the forthcoming Indian Pharmacovigilance Day 2016 Conference to be held at Peninsula Grand Hotel, Mumbai on Friday 29-July-2016 is all set to analyze and decipher the various perspectives of Drug Safety from an Indian point of view. As the Chair of the conference, I am delighted to announce that the conference agenda has been updated in the concerned section of the event website and shall continue to be updated during the following week. At this juncture, it is my duty to heartily thank all the renowned invited speakers who have honoured my invitation and confirmed their participation in the conference. I am quite confident that, with all the experts on the dais and the agenda covering a range of topics pertinent to the domain of Pharmacovigilance in India, the event will be the first of its kind and cherished forever by the delegates and speakers alike as a conference that was worth attending and well conducted. Last but not the least; I would fail in my duty if I do not thank Italy-based EasyB srl, the organizers of the ‘Pharmacovigilance Day’ series of conferences, for having announced a 25% discount as Early Bird Fees for all categories of registrations for the Indian Pharmacovigilance Day 2016, until 30-Jun-2016. Please visit the conference website or contact the organizers at +917598815311 or india@easy-b.it for registrations or more information. Looking forward to meeting you with our June 2016 news,

Oviya MedSafe – Brexit, EU Clientele & Indian Pharmacovigilance June 2016 Dear Well-Wishers, Writing the monthly newsletter of Oviya MedSafe is always a rejuvenating experience for me! As I compose the June 2016 edition of Oviya MedSafe’s newsletter, I heartily thank the thousands of our active readers from different parts of the world who have recognized the relevance of the contents of our newsletters to their day-to-day activities as pharmacovigilance professionals and have vividly expressed their appreciations to me on various occasions. The hottest news of June 2016 in the global politico-economical milieu was BREXIT. While it is still not clear on what kinds of effects Brexit would have on the pharmaceutical industry at large, its impacts on pharmacovigilance obligations, procedural changes, new compliance requirements and so on have been widely speculated. I felt the LinkedIn posts by our industry colleagues Dr Deepa 100 of 328


Arora and Dr Manoj Swaminathan worth mentioning. Some of the key speculations of concern include whether two QPPVs (one each for the EU and the UK) might be required, if EMA’s MLM service will continue to be applicable for the UK, whether a new XEVMPD will need to be compiled by MHRA, if the PSMF needs to be amended and, last but not the least on the status of the EMA Headquarters in London. The UK Pharmacovigilance Day 2016 conference which I am to Chair at London on 18th October 2016 aspires to brainstorm on this topic, among others, to bring about a direction for the way forward. As an organization incorporated in the UK also, Oviya MedSafe is actively monitoring the developments related to Brexit. With our closely knit team of pharmacovigilance professionals located both in the EU and in the UK, coupled with our global pharmacovigilance operations centralized in India, we at Oviya MedSafe anticipate no gap in our services to our present and future clients, and are well-prepared to take up any additional workload or new assignments arising out of this paradigm shift in the EU and the UK drug regulatory scenarios. If you have any business needs in this regard, please do contact us for a discussion. On the India front, the year so far has seen tremendous interest from the Indian drug regulators in bringing about pharmacovigilance guidelines for the industry with the involvement of other stakeholders. Meanwhile, the Pharmacovigilance Programme of India (PvPI) is widening its quantitative as well as qualitative reach. Given these developments, it is obvious that collaborative thinking is the need of the day and it is justified to cover this subject as a key conference topic. Accordingly, the Indian Pharmacovigilance Day 2016 conference organized at Peninsula Grand Hotel in Mumbai on 29-Jul-2016 has been conceived to foster professional interaction among all stakeholders of pharmacovigilance in India. As the Chair of the conference, I am thankful to all the reputed pharmacovigilance professionals who have agreed to be part of the conference as speakers/panellists, especially Dr Y K Gupta (National Scientific Advisor, PvPI) and Dr V Kalaiselvan (Officer in-charge of PvPI) who have kindly consented to honour this conference by their presence and involvement in the session titled PvPI Colloquium. The conference, which was featured in Pharmabiz, further covers a broad spectrum of topics ranging from Clinical Safety, Pharmacovigilance Outsourcing, Experience Sharing and Special Situations in Pharmacovigilance. At this juncture, I am happy to also announce that Oviya MedSafe has decided to join the panel of sponsors of this unique conference. Before signing off, I personally request you to consider attending the Indian Pharmacovigilance Day 2016 conference and also recommend it to your friends in the pharmacovigilance domain, with the promise of an academic feast. I hope to meet you at Mumbai. Looking forward to connecting with you through our July 2016 newsletter, Oviya MedSafe – Redefining Leadership in Pharmacovigilance 101 of 328


July 2016 Dear Well-Wishers, I am thrilled to compose this July 2016 edition of Oviya MedSafe’s newsletter which intends to spotlight our achievements during the month, with a note of emphasis on how we comprehend the purpose of our journey in pharmacovigilance across times. Being a doctor (physician) in India, every July has been important to me, as July 1st has always been celebrated as Doctors Day in the country. But, the Doctors Day of 2016 proved to be the first one that came really close to my heart, thanks to the Coimbatore Branch of the Indian Medical Association (IMA) which honoured me with the ‘Leadership Excellence Award‘, in appreciation of my leadership as a Business Leader spearheading Oviya MedSafe as a well-recognized global organization in the pharmacovigilance space, a Key Opinion Leader in the pharmaceutical industry’s regulatory discipline of pharmacovigilance and last but not the least; a Thought Leader propagating the scientific facet of pharmacovigilance as an integral part of Medicine in Practice. Although this award may be seen as a professional accolade of an individual, I wish to dutifully highlight and profusely thank my colleagues at Oviya MedSafe for sharing my passion for pharmacovigilance and for showing equal interest in supporting my non-business interests in pharmacovigilance too, as they do for our client-paid projects. With all humility, I wish to express my heartfelt gratitude to the office-bearers of IMA Coimbatore namely Dr N Mahendran (President), Dr M Mariappan (Secretary) and Dr V Rajesh Babu (Finance Secretary) for choosing to recognize me with this prestigious award. The award was presented to me by Prof. E. Balagurusamy (Former Vice Chancellor, Anna University), in the presence of Honourable Judge Thiru. A. Mohamed Jiyaputheen (Tiruppur District) and Prof. M. Padmanabhan (Course Director, State and Central Services Academy & Co-ordinator, Anna IAS Academy, Bharathiar University) on 03-July-2016 at the Doctors Day celebration of IMA Coimbatore. Moving on to the latter half of the month, I am delighted to mention that the Indian Pharmacovigilance Day 2016 conference chaired by me and sponsored by Oviya MedSafe, was held successfully at Peninsula Grand Hotel, Mumbai on 29-July-2016. Organized for the first time in India by Italy-based EasyB Srl renowned for their ‘Pharmacovigilance Day‘ series of conferences they conduct across Europe, the event was locally coordinated in India by VHEO Ventures, an event management firm. The conference began with the video welcome address of EasyB’s Managing Director Mr Enrico Pedroni and brought out various perspectives of Indian Pharmacovigilance from the constellation of extremely knowledgeable speakers and panellists, whom I wish to sincerely thank from the bottom of my heart, for making this conference a grand success with their active involvement. A detailed post-event note was published by Express Pharma, a media partner of the conference. It was a privilege that senior journalist and Editor of Express Pharma Ms Viveka Roychowdhury personally attended the conference, among many other media professionals. With houseful attendance, the event had delegates from industry, academia and the student community. The complete set of 128 photographs clicked at the conference has been made available for public viewing and/or downloading. 102 of 328


During the conference and subsequent to it, I have been able to feel and realize the immense respect that the name Oviya MedSafe has earned for itself in the minds of pharmacovigilance professionals. On introspection, I can only relate it to the relentless hard work, perpetual capability-building and cross-functional intelligence development that all of us at Oviya MedSafe have been doing over the past 52 months. We are proud as a team to state that our clients, especially those that are either currently kick-starting or propelling their pharmacovigilance systems, look up to us not just as a pharmacovigilance service-provider but as a skilled consultant who would do the best for their clients, with the implicit trust a patient would have on their doctor. With our combined solid experience of learning by working with global pharmaceutical companies (both innovators and generic drug-makers), our home-grown out-of-the-box thinking that adapts such learning for application to smaller clients and our impeccable integrity for which we are known in the industry, we at Oviya MedSafe are all set to support any kind of a client with any type of a pharmacovigilance activity and to fulfil any client’s obligations for compliance with the regulations of any market. We believe we have lots more to achieve in the vastitude and depth of pharmacovigilance in the forthcoming years. We also earnestly hope that you will be a partner in our pursuit of perfection in pharmacovigilance, in future. Thanking you for your patient reading and looking forward to meeting you through our August 2016 newsletter,

Oviya MedSafe in Outsourced Pharmacovigilance – Comprehensivising the Compartmentalised August 2016 Dear Well-Wishers, With immense fervour, I compile this August 2016 edition of Oviya MedSafe’s newsletter which aims to elucidate a key differentiating feature of ours and invite you to consider participating in two important pharmacovigilance events in which we are formally involved – one to be held in New Delhi and the other in London. Pharmacovigilance (PV) operations, especially in the outsourced scenario and more particularly when it involved offshoring, have almost always been performed in fragments irrespective of their scale. On some occasions, end-to-end processing activities were outsourced but still crossfunctional capability development within the team was not a mainstream strategy. This approach was justified until recently by the lack of experience of the newly groomed PV professionals in the evolving regions wherefrom the services were delivered and by the lead time needed by large global pharmaceutical companies to make and implement such drastic decisions, although costeffectiveness and scalability were compelling reasons for the paradigm shift to occur. 103 of 328


With the concept of PV outsourcing/offshoring having attained reasonable maturity as a business vertical in countries to which PV work has been offshored, we see that we have huge numbers of PV professionals with commendable specialist-level expertise in some specified sets of PV activities but not in all of them. It is common understanding that several sub-activities have to be sewn together to form the complete spectrum of PV as a global industry practice, with excellence in qualitative and quantitative efficiency in operations being the fine but firm interconnecting thread. While many traditional organizations providing outsourced services have the capabilities to carry out all PV activities at the organizational level, they have been finding it challenging to develop holistic PV talent at the level of each individual in their team. This can primarily be attributed to the fact that fulfilling the business goals of managing tight deadlines and heavy workloads to the satisfaction of the existing clients ranks much higher in the priority list. One could argue that concentrating on comprehensive capability development at the individual level may not be important beyond the purpose of rendering job satisfaction to PV staff. But, the need of such holistic PV thinkers is being felt, especially when the client is a small pharmaceutical company who wishes to outsource PV activities not to save cost or to enhance operational efficiency but to bring in the PV expertise they lack. Evidently, such clients do not need an expensive PV service provider that can take care of their PV liabilities only by deploying a big team because of the simple reason that their scale of operations cannot afford their charges. Hence, comprehensivising the erstwhile model of compartmentalised PV in the outsourced setting appears to be the future business need, with small and mid-sized pharmaceutical companies needing such support being many more in number than the top-rankers in the ‘Big Pharma’ which were the ones that required, created and are generally comfortable with the compartmentalisation in their outsourced PV operations, justifiably so due to their business volumes across the globe. Recent news from Europe such as the improvement in drug safety monitoring evidenced since the enactment of the new PV legislation and the release of the Designated Medical Events List by the EMA (European Medicines Agency) emphasize the fact that performing good PV indeed alters the benefit-risk ratio of the medicinal product in favour of the consumer. While this obvious truth has been proven on multiple occasions in the western world, the ‘Emerging Markets’ or ‘RoW Countries’ are not far behind in learning from the global past, and their competent authorities have begun to increasingly adopt PV as a regulatory norm for the pharmaceutical industry. Given this scenario, holistic PV professionals capable of creating PV systems and meticulously carrying out various PV activities in compliance with them are required in order to fulfil the drug safety obligations of the pharmaceutical industry, especially in these regions and more specifically for generic drugmakers that have limited budgets for PV. Acclaimed and individually well-experienced PV experts are available, although not in huge numbers, to create systems but a Comprehensive Boutique Consultancy is what is required to establish and run a PV system in an organization that hitherto did not have one, and not just a service provider accustomed to the conventional model of Compartmentalised PV or an individual expert who could perform only an advisory role. 104 of 328


At this juncture, I am proud to state that Oviya MedSafe is pioneering the evolution from today’s world of compartmentalisation to tomorrow’s need of comprehensiveness in PV, without compromising on any of the principal tenets of a PV business enterprise which includes regulatory compliance, cost-effectiveness, scalability and deployment of appropriate technology, among others. It is not surprising for me because Oviya MedSafe was conceived that way. Although we have never hesitated to function as a conventional PV service-provider to clients who have strong drug safety systems, we always felt that our all-encompassing support has been most needed by drug manufacturers and/or marketing authorization holders with absent, nascent or inadequate PV systems. Our aspiration of being identified by the industry as the “Single Window” to go to for all their PV requirements has been achieved, thanks to the smart work of Team Oviya MedSafe over the past four and a half years. We believe that this professional philosophy makes Oviya MedSafe unique and will continue to inspire all our strategies for the future. Moving on to the first of the two events I hinted about, I am delighted to announce that Oviya MedSafe will be a sponsor of the 3rd National PV Symposium of the Indian Society for Clinical Research (ISCR), which is to be held on Saturday, 24-Sep-2016 at Holiday Inn New Delhi International Airport, New Delhi. The theme of the symposium is “Evolving a Pharmacovigilant Environment in India – Collaborations, Opportunities & Challenges” and it has renowned speakers representing all stakeholders of PV in India. Incidentally, I have been asked to speak at the symposium on the topic “PV as a value addition to the pharmaceutical industry in contemporary Indian scenario“, which I eagerly look forward to. I wish to take this opportunity to invite you to register online to attend the symposium by visiting the URL www.iscrpvsymposium.com which also has the agenda and the facility to receive online payments for ensuring quick completion of registration. Last but not the least; I am pleased to mention that I will be travelling to London to Chair the UK Pharmacovigilance Day 2016 conference, which has shaped up quite well with a mix of conventional and innovative PV topics for deliberation. I will write more about this conference in our next newsletter but wish to request you to start registering to attend as the places are filling up fast. Needless to say, I will be available and keen to meet UK colleagues for business discussions during my forthcoming short stay in the UK in October 2016. Thanking you for the patient reading and awaiting to connect with you through our September 2016 newsletter,

Oviya MedSafe – India Pharmacovigilance Support for Local Affiliates of Global Pharma October 2016 Dear Well-Wishers,

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I am delighted to present to you this October 2016 edition of Oviya MedSafe’s newsletter, by which I intend to provide an overview of Oviya MedSafe’s customizable support services meant to address the local pharmacovigilance requirements of Indian affiliates of global pharmaceutical companies (manufacturers/importers). The term ‘Local Affiliate’ typically refers to a Strategic Business Unit (SBU) of a foreign parent organization that has the mandate of carrying on the business activities of the enterprise in a particular country or region, in line with the global policies and local laws. Local affiliates may either be locally incorporated subsidiaries of the foreign parent organizations or may also be third parties bound to the enterprise by contractual agreements. In the global pharmaceutical industry, many companies operate in the ‘Local Affiliate’ model. The general functions of local pharma affiliates may vary based on whether the parent company is an established innovator pharma, a multinational generic drugmaker, an emerging biotechnology firm, a vaccine producer, a medical device manufacturer or any other entity. Further, each enterprise may have its own structure and hierarchy for its local affiliates. The scope of pharmacovigilance activities at a local affiliate level is drastically different from that at a central processing unit which performs routine global pharmacovigilance activities. A local affiliate has the primary responsibility of complying with the pharmacovigilance regulations at the country/region level, while also ascertaining that the activities do not contradict the global pharmacovigilance policies of the organization. While achieving this is a huge challenge by itself, the affiliate has the additional responsibilities of promptly submitting ICSRs/PSURs/RMPs and other pharmacovigilance reports to the competent national/regional authorities, maintaining Safety Data Exchange Agreements (SDEAs) with other applicable stakeholders, providing pharmacovigilance training to business partners & staff, performing local literature monitoring and being in charge of pharmacovigilance audits & inspections of the affiliate. Apart from these activities, pharmacovigilance departments in the affiliates provide support to their Medical Affairs and Clinical Trials colleagues, whenever business needs arise. The affiliate also needs to function as a local point of contact for pharmacovigilance in the concerned country/region, especially for regulatory interactions. In some countries, a person has to be named as Qualified Person for Pharmacovigilance (QPPV) or Local Responsible Person (LRP) for such purposes. The volume and complexity of work at any given local affiliate is largely dependent on the maturity of the respective local regulatory agency. With the increasing trend of centralized outsourcing of global pharmacovigilance operations to end-to-end service providers, pharmaceutical companies do not find continuous business needs which warrant sizeable pharmacovigilance teams at the affiliate levels. However, this poses a challenge when the affiliate’s workload increases due to unforeseen reasons such as a sudden safety concern or a change in regulation. Since affiliates have their own inherent and regular duties to fulfil with their limited headcount, such spikes in workload can potentially threaten their compliance status. Anticipating such situations, many pharmaceutical companies hire specific third party service providers for local pharmacovigilance support, whenever in need. This partnership differs to a great extent from the centralized outsourcing relationship the company 106 of 328


has with a much larger service provider, as focus on and a realistic understanding of the local market scenario are more important determinants in such situations. In fact, a small to mid-sized boutique consultancy with a strong business presence in the concerned country/region may be able to better cater to such specific local requirements than a huge central processing unit. Oviya MedSafe, despite being a comprehensive global pharmacovigilance consulting and outsourced drug safety services partner for a number of clients worldwide since 2012, has always been at the forefront in supporting Indian pharmaceutical companies and Indian affiliates of global pharmaceutical companies for their local compliance too. Some of Oviya MedSafe’s successful deliveries in this segment include the following activities: – Corporate pharmacovigilance training; – Writing PSURs for submission to CDSCO; – Local literature monitoring; – ICSR processing & XML-E2B format reporting to PvPI; and – Analysis of safety data from patient support programmes. We at Oviya MedSafe, with our rich experience in Indian pharmacovigilance, are empowered to undertake all the pharmacovigilance responsibilities of Indian affiliates of global pharmaceutical companies either in total or in parts, including safety management of company-sponsored clinical trials and postmarketing surveillance studies in the country/region with deployment of a regulatory-compliant drug safety software database where required. We believe that we are highlighting this particular segment of our portfolio of offerings at the right time, as the Indian regulatory system gears up to perform audits on Marketing Authorization Holders (MAH) while urging them to establish well-integrated pharmacovigilance systems in their organizations. If you wish to know more about these featured services of Oviya MedSafe, please do not hesitate to contact us. I hope you found this communication to be of interest and thank you for your patient reading. Looking forward to connecting with you through our November 2016 newsletter edition,

Oviya MedSafe – Pragmatic Pharmacovigilance Support for US ANDA Holders November 2016 Dear Well-Wishers, I am elated to present to you this November 2016 edition of Oviya MedSafe’s newsletter which aims to provide a quick overview of the pharmacovigilance obligations of generic drug manufacturers/marketers who are holders of Abbreviated New Drug Applications (ANDAs) in the 107 of 328


United States (US) and how we at Oviya MedSafe help such clients of ours comply with the relevant drug safety regulations of US Food & Drug Administration (FDA). By definition, an ANDA is an application for approval of a generic drug in the US, for an existing licensed medication or approved drug, and contains data which when submitted to FDA, provides for the review and ultimate approval of the concerned generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. In order to gain FDA approval, a generic drug must: – contain the same active ingredients as the innovator drug (inactive ingredients may vary); – be identical in strength, dosage form, and route of administration; – have the same use indications; – be bioequivalent; – meet the same batch requirements for identity, strength, purity, and quality; and – be manufactured under the same strict standards of FDA’s Good Manufacturing Practice regulations required for innovator products. Although animal/human data for safety or effectiveness need not be submitted as part of an ANDA, pharmacovigilance obligations for generic drugs are no different from those for FDAapproved innovated products. Hence, having a robust pharmacovigilance system in place is an indispensable prerequisite for any current or aspiring ANDA holder, irrespective of the number of ANDAs or the composition of the products. The system, which can be either in-house or outsourced in full/part, should be backed by written procedures and have the means in place to collect safety information from all possible sources of spontaneous Adverse Drug Experience (ADE) reports such as Healthcare Professionals, Consumers, Literature, Regulatory Authorities and others, in compliance with 21CFR314.80 for small molecules and 21CFR600.80 for biologic products including vaccines. ANDA holders need to perform the following pharmacovigilance activities on a regular basis for all their approved ANDAs irrespective of the marketing status of the ANDAs, in order to be able to fulfil their US pharmacovigilance obligations detailed in 21CFR314.80 and 21CFR600.80: •Processing of all reported ADEs as Individual Case Safety Reports (ICSRs); •Electronic reporting of 15 Day reports (serious & unexpected cases); •Global literature monitoring for identifying valid ICSRs; and •Preparation and submission of PADERs (quarterly for 3 years and annually thereafter). Apart from the above, FDA may occasionally ask for Risk Evaluation and Mitigation Strategies (REMS) to be submitted in order to ensure that the benefits of a product outweigh its risks, if deemed required. FDA has the authority to inspect the site(s) at which the 108 of 328


pharmacovigilance operations of the ANDA holder are carried out, regardless of their geographical location. An important point that any ANDA holder has to bear in mind is that the FDA expects ADE reports associated with their products marketed not only in the US but from anywhere in the world to be submitted to FDA. Hence, lack of compliance in other markets has a direct implication on the US compliance status of the said ANDA holder. FDA may withdraw approval of the ANDA and prohibit continued marketing of the product in the US, if the ANDA holder fails to comply with their pharmacovigilance obligations. Given the scenario that possession of US ANDAs directly enhances the valuation of a pharmaceutical company, prudent pharmaceutical business houses would not risk their ANDAs by compromising on pharmacovigilance. We at Oviya MedSafe, with our strong team of experienced pharmacovigilance professionals and proven expertise in deploying 21 CFR Part 11 compliant cost-effective drug safety software databases for multiple clients, are well-prepared to provide comprehensive pharmacovigilance coverage for ANDA holders seeking a pharmacovigilance service-provider. With our formidable track record of setting up drug safety systems and performing the routine pharmacovigilance activities for many small and medium sized clients including some of those for US FDA compliance, we are proud that Oviya MedSafe is seen by emerging pharmaceutical companies across the globe as their strategic pharmacovigilance partner to support their business expansion in the US market without fearing the burden of compliance. While speaking of pharmacovigilance as a perceived ‘fearsome burden’ to the pharmaceutical industry, I, as a pharmacovigilance aficionado, always tend to disagree. This led me to position ‘Pharmacovigilance as a Value Addition to the Pharmaceutical Industry‘ during my talk of the same name at a conference earlier this year, which was subsequently featured in Oviya MedSafe’s September 2016 newsletter. Interestingly, this led Ms Viveka Roychowdhury, Editor of leading Indian pharmaceutical industry magazine Express Pharma, to invite me to develop my presentation into a full-fledged article which was eventually published on 20-Nov-2016 in the CPhI India special issue. Along with my QA colleague Mr Karunakaran Shanmugam who assisted me in articulating my thoughts on this topic, I have highlighted in this article the significance of pharmacovigilance for the pharmaceutical industry, beyond its ethical/moral commitment to Patient Safety. I hope you will find the article which is available online at http://www.expressbpd.com/pharma/management-pharma/pharmacovigilance-as-a-valueaddition-for-the-pharma-industry/378975/ to be of interest and look forward to your comments on its contents. Waiting to connect with you soon through our December 2016 newsletter,

Oviya MedSafe fosters Industry-Academia Partnerships for Pharmacovigilance December 2016 109 of 328


Dear Well-wishers, As we near the end of an eventful 2016 and expectantly get ready to welcome a promising 2017, I delightfully gather my thoughts for this December 2016 edition of Oviya MedSafe’s newsletter, with hearty New Year wishes from Team Oviya MedSafe for a Happy & Prosperous 2017! Being an organization that passionately practices our chosen profession of Pharmacovigilance, Oviya MedSafe has always been proactive in sharing our knowledge with students and aspiring professionals. In fact, empowering more people, especially those in our immediate environment, to develop their expertise in Pharmacovigilance has been an intrinsic trait of Oviya MedSafe which I see as being directly related to our undaunted commitment to promoting the science of Drug Safety for the cause of Patient Safety. Oviya MedSafe’s interactions with academic institutions began as early as the founding of the organization in 2012. The journey, which started with my guest lectures at several colleges and universities offering courses in Medicine, Pharmacy and Life Sciences, moved on to the stage wherein we organized one-day workshops for students and young professionals. Such workshops held at Coimbatore in 2013 (as part of our Launch), at Singapore in 2015 (as a post-conference workshop at the 6th Annual Pharmacovigilance Asia 2015 conference) and at Bengaluru in 2016 (on Narrative Writing) were well-received. Although we have conducted numerous corporate training workshops for pharmaceutical companies on more complex topics in Pharmacovigilance, our workshops for academic institutions have always held a special place in our heart, as they meant that we were addressing a societal need seldom understood or acted upon by others. With immense pride, I wish to inform you that we are all set to upgrade our interaction with the academia to that of a formal partnership in early 2017, by signing up to collaborate with the Department of Biotechnology of the reputed Kumaraguru College of Technology (KCT), Coimbatore for a One Credit Course on Pharmacovigilance, as the Industry Partner. I consider this as a great honour for Oviya MedSafe and look forward along with my colleagues to taking the responsibility of teaching the fundamentals of pharmacovigilance to KCT’s Biotechnology students. Apart from KCT, Oviya MedSafe has already signed a Memorandum of Understanding with RVS College of Pharmaceutical Sciences, Coimbatore for a long-term IndustryAcademia Partnership. Many such agreements with other educational institutions too are under discussion and are expected to be announced in the forthcoming months. We firmly believe that our warm relationships with colleges/universities, especially those in and around Coimbatore where our Global Delivery Centre is located, will also render to us the collateral benefit of forming the foundation for the organic growth of Oviya MedSafe’s team size in the future. Being a growing and global organization, we are also keen to collaborating with academic institutions in other parts of 110 of 328


India and outside India as well, remaining open all the time to the idea of expanding our operations to other regions/countries depending on our business needs. Before concluding, I am glad to let you know that Oviya MedSafe will be organizing an independent Pharmacovigilance workshop for students and aspiring professionals, at Coimbatore on account of Oviya MedSafe’s 5th Anniversary in March 2017. The exact date, venue and agenda of the workshop will be announced shortly. I take this opportunity to once again wish you a phenomenal 2017 Looking forward to meeting you through our January 2017 newsletter, Oviya MedSafe – Building Pharmacovigilance Strategies & Invited Article in DIA Global Forum January 2017 Dear Well-wishers, As all of us navigate further into the New Year, I am overjoyed to recollect how the year 2016 enabled Oviya MedSafe to metamorphose to what we are today with our established credentials in building pharmacovigilance strategies for our clients, in this January 2017 edition of our newsletter! Until 2015, although Oviya MedSafe handled several projects for fulfilling the drug safety obligations of many multinational pharmaceutical and biotechnology companies (both innovators and generic drug manufacturers/marketers) mandated by the concerned regulatory agencies including the EMA and the FDA, we were either requested by our clients to perform specific tasks in line with their drug safety systems and business needs or asked to provide strategic inputs with deliverables limited only to serve as documentation of our consulting support. However, our new clients in the year 2016 transformed Oviya MedSafe into their Strategic Pharmacovigilance Partner, thanks to our unrelenting compliance with our own philosophy which facilitated our consistent growth from a start-up organization in 2012 to a trustworthy brand name to reckon with in the global pharmacovigilance domain in 2016. In 2016, Oviya MedSafe had several opportunities to set up and start running pharmacovigilance systems for a variety of clients who signed end-to-end long-term contracts with us. Such clients ranged from absolute beginners in pharmacovigilance to those having some pharmacovigilance structure, albeit inadequate, in place. Oviya MedSafe’s innate ready-to-deploy SOPs with a customized approach for each client, solid regulatory pharmacovigilance intelligence, vibrant team of well-experienced pharmacovigilance professionals, robust quality assurance department, mature project management expertise and on-demand access to a cost-effective 21 CFR Part 11 and E2B compliant global drug safety software database were recognized as boons by these new 111 of 328


clients who partnered with Oviya MedSafe, especially those who approached us at the eleventh hour with little time left for us before going live. The fact that our clients find us comfortable partners to work with and rather feel protected by being our clients continues to result in successful referral businesses for Oviya MedSafe, which symbiosis we anticipate to leverage for the benefit of all the concerned parties in 2017 too and beyond. Moving on to updates about our plan for celebrating Oviya MedSafe’s 5th Anniversary (first announced in our December 2016 newsletter), we have identified 17th & 18th March 2017 as the dates for the pharmacovigilance workshop we will be organizing at Coimbatore, India for students and aspiring professionals. By conducting this 2-day workshop, we intend to enhance the appetite of Medical/Pharmacy/Life Sciences students & young graduates to take up pharmacovigilance as a career and to engage healthcare professionals in a dialogue on how the adoption of pharmacovigilance in their practice could be improved for patient safety. The workshop will have invited talks, lectures, Q & A sessions, panel discussions, hands on exercises and pre-selected free paper/poster award presentations by delegates. Continuing Medical/Pharmacy Education (CME/CPE) credit points, as applicable, will be applied for. The formal brochure of the workshop along with the agenda and the modus operandi & delegate registration fee details will be released within a couple of weeks. For any queries regarding this workshop, please write to register@oviyamedsafe.com. On another note, I am delighted to inform you about the continuation of my relationship with the ‘Pharmacovigilance Day‘ series of events conceptualized by Life Science Academy, a business unit of Italy-based EasyB Srl. I will be the Chair of the UK Pharmacovigilance Day 2017 conference to be held at London, UK on Tuesday 6th June 2017 and the Indian Pharmacovigilance Day 2017 conference to be held at Hyderabad, India on Friday 28th July 2017. In addition, Oviya MedSafe will be a sponsor of the latter event. More details about these conferences will be available on the websites of the respective conferences as the agenda get structured and speakers are finalized. Please do bookmark these dates and kindly ensure your participation to make these events successful. Before signing off, I wish to share with you my invited article “Pharmacovigilance Programme of India: SWOT Analysis” which has been published in the Drug Information Association‘s (DIA) digital magazine ‘Global Forum‘, in its just-released February 2017 special edition on ‘Product Safety’ that features content created by global leaders in the Drug Safety arena. The article is available on the URL http://www.globalforum-online.org/Feb2017/index.html?page=22 for free reading, irrespective of the reader’s DIA membership status. I welcome your feedback on this article and will look forward to hearing from you. Please do not hesitate to share the link to this article with anybody who may find this subject interesting. Waiting to re-connect with you through our February 2017 newsletter, Oviya MedSafe – DRUG DILIGENCE 2017 and Honours from DIA & ISPOR 112 of 328


February 2017 Dear Well-wishers, With tremendous avidity, I present to you this February 2017 edition of Oviya MedSafe’s newsletter, which is the proud 59th issue of the monthly series I have been writing ever since I founded the brand Oviya MedSafe on 14th March 2012. Although I thoroughly enjoy the creative journey of synthesizing the newsletter every month with details of Oviya MedSafe’s key organizational milestones, featured drug safety services, selected case studies from our pharmacovigilance consulting portfolio, scientific publications, general information of interest to global as well as regional pharmacovigilance enthusiasts, and above all the narratives of our expeditions beyond business to propagate the science of Drug Safety for the cause of Patient Safety, I earnestly believe that it is the meticulous set of the now 18000+ strong size of our readership that has continuously motivated me to do this throughout these 5 years with the same level of enthusiasm I had when I released the first issue. Quite naturally, this brings us to the focal sub-topic of this newsletter – the forthcoming 5th Anniversary of Oviya MedSafe’s founding. We at Oviya MedSafe have planned to celebrate our 5th Anniversary by doing what we love the most, namely satiating our deep-rooted desire of enlightening our immediate environment with learnings from our travel in pharmacovigilance so far. For this purpose, Oviya MedSafe has partnered with event management firm VHEO Ventures, to organize DRUG DILIGENCE 2017, a Two Day National Level Conference & Workshop on Pharmacovigilance, at IMA Hall, Coimbatore on 17th & 18th March 2017. The event is open to all responsible stakeholders of Patient Safety, for them to hear, discuss and clarify various aspects of Pharmacovigilance. The programme has renowned national and local faculty from the academia, pharmaceutical industry, government officials and service providers in pharmacovigilance & related segments. I am enthused to emphasize the fact that The Tamil Nadu Dr MGR Medical University has awarded 20 CME Credit Points under Category III, for DRUG DILIGENCE 2017. The highlight of the programme is a paper presentation session on pharmacovigilance which is exclusively meant for student delegates. Ten papers will be shortlisted for presentation from the abstracts received in prior and the first three places will be adjudged and awarded by the Guest Speakers. The brochure along with the delegate registration form for DRUG DILIGENCE 2017 may be downloaded in PDF format from Oviya MedSafe’s downloads page. Alternatively, the JPEG format images of the document may be accessed through my LinkedIn article or Oviya MedSafe’s Facebook post. I request you to kindly consider registering to attend this event and also forward the brochure to any of your friends who may be interested. 113 of 328


The very next week following DRUG DILIGENCE 2017, I will be speaking on the topic “Indian Pharmacovigilance – Where do we stand today?” at “PV Fast Forward” – Technology, Pace, Priority, the annual pharmacovigilance conference of the Drug Information Association (DIA) in India, which is to be held at Mumbai. In this slot, I wish to provide a critical independent review of the governmental initiatives in pharmacovigilance in India. In addition, I have played the role of a Program Committee Member of this annual conference consecutively for the second year, thanks to DIA. I owe much more gratitude to DIA for entrusting me with the responsibility of ‘Regional Editor, India‘ of Global Forum (the official magazine of DIA) from its April 2017 issue. Although the fact that the position was last held by Late Prof. Ranjit Roy Chaudhury made me a little bit anxious, I have accepted DIA’s invitation as I am confident that your encouragement and support will help me succeed in this role, for India. Interestingly, I am to publish this February 2017 newsletter from New Delhi where I have been invited to speak on an intriguing topic ‘The Role of Pharmacovigilance in Pharmacoeconomics‘, at the 5th National Conference of Pharmacoeconomics & Outcomes Research organized under the aegis of ISPOR India at the Delhi Pharmaceutical Sciences & Research University on 3rd & 4th March! While speaking of all these events, it is my duty to update you that the agendas of the UK Pharmacovigilance Day 2017 (London) and the Indian Pharmacovigilance Day 2017 (Hyderabad) conferences which I will be chairing are shaping up quite well. I look forward to share these conference reports and other updates too through Oviya MedSafe’s March 2017 newsletter (60th issue). Thanking you for your patient reading, Oviya MedSafe – 5 Years in Pharmacovigilance – 60th Newsletter March 2017 Dear Well-wishers, I am heartened to script this March 2017 edition of Oviya MedSafe’s newsletter, which marks our illustrious 60th monthly issue that aspires to curate memorable moments from the enthusiastic celebrations of Oviya MedSafe’s 5th anniversary! Apart from reporting the Drug Diligence 2017 event that was held on this account, I will also outline in this bulletin some experiences I gathered while speaking at two other important conferences during the month, as already assured in our February 2017 newsletter.

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My eager anticipation for March 2017 began with the pleasant surprise of a personal invitation to me from veteran pharmacologist and President of ISPOR India Regional Chapter Prof Dr S K Gupta (Advisor, Pharmacovigilance Programme of India) to speak on the topic ‘The Role of Pharmacovigilance in Pharmacoeconomics’ at the 5th National Conference of Pharmacoeconomics & Outcomes Research organized under the aegis of ISPOR India at New Delhi! The conference was a privileged opportunity for me to closely interact with Dr S K Gupta and with Prof Dr Ramesh K Goyal, Vice Chancellor of Delhi Pharmaceutical Sciences & Research University (DPSRU) where the programme was conducted. I am glad to share with you some pictures from the event, through this link. While preparing for my talk, I had a chance to dive deeper into the fascinating science of Pharmacoeconomics, all the time trying to draw parallels with my subject of Pharmacovigilance. Although it is evident that Pharmacoeconomics considers the safety aspects of a drug to be a key determinant during its cost-effectiveness analysis, I could better appreciate the fact that the dynamic nature of the benefit-risk profile of any drug means that pharmacoeconomic measures too need to be constantly reviewed as and when new Pharmacovigilance information emerges. During my talk, I also highlighted reasons for why pharmacovigilance and pharmacoeconomics professionals need to work together in the long run, for the benefit of patients. It is my pleasure to share with you the slide deck of my presentation, which can be accessed through Oviya MedSafe’s downloads page. Coming to the core topic of the 5th anniversary of Oviya MedSafe’s founding, I hope you might recall that Oviya MedSafe partnered with event management firm VHEO Ventures, to organize Drug Diligence 2017, a National Conference & Workshop on Pharmacovigilance, at IMA Hall, Coimbatore. Drug Diligence 2017 was inaugurated by the Chief Guest Dr Y K Gupta, Professor & Head of the Department of Pharmacology, All India Institute of Medical Sciences, New Delhi who is also the National Scientific Coordinator of the Pharmacovigilance Programme of India. Dr N Shanthi, Professor & Head of the Department of Pharmacology, Coimbatore Medical College, Coimbatore was the Guest of Honour. Ms Indu Nambiar, Senior Manager – Local Pharmacovigilance, Boehringer Ingelheim India Pvt Ltd, Mumbai and Ms Vasumathi Sriganesh, Honorary CEO, QMed Knowledge Foundation, Mumbai offered felicitations. During the inauguration, I presented a report of Oviya MedSafe’s achievements in the past 5 years. Dr V Janarthanan, Chairman, Oviya MedSafe welcomed the gathering and Dr C J Arun Raja, Director, Oviya MedSafe delivered the vote of thanks. The dignitaries deliberated upon various pharmacovigilance topics and also honoured all speakers of Oviya MedSafe, voluntary supporters of the event and the winners as well as participants of the paper presentation session held as part of the two-day event. I take this opportunity to immensely thank Dr Y K Gupta for accepting my invitation and coming all the way from New Delhi to inaugurate Drug Diligence 2017 and wish all of us at Oviya MedSafe on our 5th anniversary. It was a defining moment in my life to host him at Coimbatore on this special occasion, especially in the presence of my teacher Dr N Shanthi, to whom I owe a lot of gratitude. I also wish to thank Ms Vasumathi Sriganesh and Ms Indu Nambiar for the time and effort they put 115 of 328


in for effectively sharing their knowledge with the delegates. Some pictures from the Inauguration, proceedings of Day 1, proceedings of Day 2 and the Valediction may be viewed / downloaded from the respective links. The detailed post-event Press Release prepared by VHEO Ventures is available on our website. At this juncture, I wish to acknowledge the media houses Express Pharma, Pharmabiz, Covai Post and PV Chronicle whose extensive coverage of Drug Diligence 2017 helped a great deal in raising awareness about the programme. Following the successful Drug Diligence 2017, I travelled to Mumbai to speak at PV Fast Forward – Technology, Pace, Priority – the annual pharmacovigilance conference of the Drug Information Association (DIA) in India. During my speech titled ‘Indian Pharmacovigilance – Where do we stand today?‘, I presented a status update on the initiatives taken for pharmacovigilance of the Indian population followed by a SWOT Analysis of the Pharmacovigilance Programme of India (PvPI), adapted and developed further from my recent article for Global Forum, the official magazine of the DIA. With the added honour of representing India on the editorial board of Global Forum from April 2017, it was an appropriate topic for me to speak on at the august gathering. The session was well-received by the audience and led to quite a lot of interaction. Pharmabiz quoted my presentation at this conference, while publishing a report on a related topic. It is my duty to thank DIA for inviting me to also serve on the Program Committee of this resourceful event. Before signing off, I wanted to update you that some details of the UK Pharmacovigilance Day 2017 (London) and the Indian Pharmacovigilance Day 2017 (Hyderabad) conferences which I will be chairing have been updated on their respective websites. Please keep watching these websites for more information in the next few weeks. Waiting to re-connect with you through our April 2017 edition,

Oviya MedSafe as an Innovation Strategist in Global Pharmacovigilance April 2017 Dear Well-wishers, I am surprised that April 2017 has passed so soon and the corresponding edition of Oviya MedSafe’s monthly newsletter is already due, even as I continue to respond to those of you who have been heartily congratulating us on Oviya MedSafe’s 5th Anniversary festivities, which I covered in detail in our March 2017 newsletter. Today, Oviya MedSafe stands tall as a specialized, methodical and trustworthy organization in the domain of Global Pharmacovigilance. At this juncture, I look back with pride at the road Oviya MedSafe has travelled thus far and relish the fact that we have reached where we are today not only because of our perseverant dedication to pharmacovigilance as a science but also because 116 of 328


we were constantly innovating ourselves as a boutique consultancy firm to address the knowledge and affordability deficit in the pharmaceutical industry, in terms of pharmacovigilance services. I wanted to take this opportunity to dwell upon a visionary moment which came true and thereby resulted in a major strength for Oviya MedSafe, only to be adopted subsequently by many other organizations in the pharmaceutical industry. Way back in 2012 when I founded Oviya MedSafe, I used to encounter quite a lot aspiring entrepreneurs who wanted to set up firms to offer pharmacovigilance services. Any discussion with such colleagues used to begin with the point that upfront investments for procuring drug safety software database licenses were vital prerequisites for such an organization to begin operating. As a conscientious pharmacovigilance professional, I had always felt that possessing strong functional expertise in pharmacovigilance was of much more importance for a consulting organization rather than just having the gold standard drug safety software database in place. Of course, electronic databasing and/or reporting had already become the norm by then, particularly in developed countries. While I was confident of building a robust drug safety team at Oviya MedSafe which could provide services at lesser costs, I sensed that investing in expensive software databases which were considered market leaders would eventually skyrocket the end cost to our clients, especially small and medium-sized pharmaceutical companies, thereby making our proposals less attractive to them in terms of pricing. But, I also understood that not having a pharmacovigilance database or using a non-validated one would simply make us a technologically outdated organization. My quest for the best of both worlds ended when I identified a pre-configured, pre-validated, E2Bcompliant and 21 CFR Part 11-compliant hosted human pharmacovigilance software database system known as PV247 – a product of UK-based Assured Information Systems Ltd, now part of the France-based Ennov group. Oviya MedSafe’s partnership with Assured was publicized in April 2014 following a meeting I had with Dr Alan K Rawling (the then Managing Director of Assured) during my visit to the UK earlier that year. I cherish the good memories of my conversations with Dr Rawling whose business philosophy was in perfect harmony with that of mine. As expected, our alliance grew to be a successful one, although Dr Rawling was unfortunately not alive to see it. Today, many organizations that provide pharmacovigilance services have entered into such strategic relationships with multiple drug safety database systems, especially in developing countries which are beginning to adopt E2B systems. However, Oviya MedSafe’s preferential pact with Assured was the window for the pharmaceutical industry in India and the Asia Pacific region to consider adopting lesser known yet robust drug safety databases beyond the renowned expensive ones. Our novel approaches thus enabled us to render end-to-end pharmacovigilance services not only for India and emerging markets but also for compliance with the pharmacovigilance mandates of well-established global regulatory agencies including the US FDA. Back to the present, I wish to spotlight the 2017 edition of the UK Pharmacovigilance Day conference, which I have been chairing since its inception in the year 2015. I eagerly look forward to travelling to London for this conference which has to its credit a galaxy of reputed speakers across all stakeholders of pharmacovigilance in the UK. The conference has been 117 of 328


designed to cover a wide variety of topics ranging from BrExit, technological breakthroughs, automation, viewpoints of patients, etc in the context of pharmacovigilance. I take great pleasure in inviting you to register for this knowledge-packed conference. Apart from the conference, I hope I will be able to also have one-on-one meetings with some of you in the UK for conversations of mutual interest during the first fortnight of June 2017. Please do let me know if you would like to schedule a meeting. On the Indian front, I am glad to announce that the venue for the Indian Pharmacovigilance Day 2017 which is to be chaired by me has been identified as Hotel Lemon Tree Premier, HITEC City, Hyderabad. The conference to be held on Friday 28-July-2017 happens to be the first large scale gathering focused on pharmacovigilance to be organized in the city of Hyderabad in the recent past. I am delighted to state that well-recognized pharmacovigilance physicians like Dr Vivek Ahuja, Dr Arani Chatterjee, Dr P Usharani and Dr Ramesh Jagannathan have confirmed their availability to join the event as Invited Speakers. Please keep watching the conference website for the full agenda, names of the remaining speakers and information on registration/sponsorship which shall be updated shortly. I am sure that this conference will be as successful as its 2016 edition which I chaired in Mumbai last year, with your support as always. Keen to reach you through our May 2017 edition from London,

Oviya MedSafe – Certified MedDRA Coders and Pharmacovigilance Torchbearers May 2017 Dear Well-wishers, I begin writing this May 2017 edition of Oviya MedSafe’s newsletter with tremendous joy on the achievement of an organizational milestone: Ten of our team members have made Oviya MedSafe proud by clearing the Certified MedDRA Coder (CMC) examination, with all of them taking the test simultaneously and for the first time! While I express my personal note of hearty congratulations to my ever-reliable colleagues, I wish to add a little more context on the significance of this certification. The CMC examination is a rigorous test of an examinee’s coding ability and knowledge on the Medical Dictionary for Regulatory Activities (MedDRA), conducted by the MedDRA Maintenance and Support Services Organization (MSSO) contractor. The examinees need to have a working knowledge of the principles of MedDRA term selection as outlined in the MedDRA Term Selection: Points to Consider (PTC) document, including preferred options, the details of which may be downloaded from the MedDRA Support Documentation page. The current examination uses MedDRA Version 20.0 and the Term Selection PTC, Release 4.13. The ICH MedDRA Management Board recognizes 118 of 328


the importance of continuous MedDRA training as a best practice and the value of a coding certification. However, it is not within its scope to offer such a certification and it is not a regulatory requirement. As an organization that treats passion for pharmacovigilance, continuous learning to empower clients, perpetual capability-building, and deep-rooted business integrity as its core values (Philosophy) in letter and spirit, Oviya MedSafe sees this certification of our employees as an authentic endorsement of our expertise in the domain. We believe it also validates the high performance of our training and quality management systems, into which we now look forward to bring in further advancement by getting the rest of our (present and future) staff to clear the CMC examination in the forthcoming months. While on this topic, I believe it would be relevant to share with you that Oviya MedSafe is keen to expand its Medical Review team at Coimbatore, India. The detailed job advertisement is available on my LinkedIn Article and I take this opportunity to invite eligible and interested candidates to apply by sending their CVs to the e-mail address provided. Oviya MedSafe has always strived to be in the first line of action in any pharmacovigilance activity that it could participate at any level, which has quite appropriately earned for us the descriptor ‘Torchbearers for Pharmacovigilance’ from doyens in the domain, which remark is something I consider quite close to my heart. I firmly believe that it has been due to not my efforts alone but a lot to the camaraderie of my enthusiastic team, to whom I once again wish to express my heartfelt thanks at this moment. Before concluding this letter, I am happy to inform you that the registrations for the Indian Pharmacovigilance Day 2017 conference which I am to Chair at Hyderabad on 28-July-2017 are now open. Please visit the registration page for more details and to avail the Early Bird benefits which would be available until 30-June-2017. The details of confirmed speakers are already available on the speakers page. The agenda with a few more speakers whose confirmation is awaited, shall be posted on the agenda page soon. I eagerly wait to share my UK Pharmacovigilance Day 2017 experiences with you through our June 2017 newsletter which you can expect in the first week of next month. Oviya MedSafe and Pharmacovigilance Days – London Experiences & Hyderabad Expectations June 2017 Dear Well-wishers, As I start penning this June 2017 edition of Oviya MedSafe’s newsletter, I cannot help getting overwhelmed by the heartfelt appreciations I received from many of you in the context of Team 119 of 328


Oviya MedSafe’s achievements in clearing the Certified MedDRA Coder (CMC) examination, about which I had written in detail in Oviya MedSafe’s May 2017 newsletter. I felt personally gratified by a particular comment from a long-term observer which went on to mean that Oviya MedSafe’s progressive growth over the past 5 years has a lot to do with the organization’s behaviour of constantly working hard to earn such genuine credentials on an ongoing basis without showing any sign of slowing down to join the rat race in the pharmacovigilance domain. The month of June 2017 was refreshing in the sense that I could take a quick break to travel to London amidst the hectic workload pertaining to new projects which were being initiated at our Global Delivery Centre in Coimbatore. I had the privilege of chairing the ‘UK Pharmacovigilance Day‘ conference (consecutively for the third time since its inception in 2015) at London on 06-Jun2017. For those who may not know, the ‘Pharmacovigilance Day’ conferences are annual one-day events organized by EasyB srl, an Italy-based conference-producing company, which aspire to bring together Drug Safety experts from the pharmaceutical and healthcare industry: pharma & medical devices companies, biotechnology firms, government agencies, academic research and so on, from a specific country or region with the aim of discussing pharmacovigilance issues that are unique to the concerned country/region. The 2017 edition of the UK Pharmacovigilance Day conference invoked loads of inquisitiveness, thanks to the impending BrExit and the apprehensions about the possible impacts of BrExit on the UK pharmacovigilance system. Along with the experts from MHRA and industry deliberating on various facets of pharmacovigilance such as technology, regulations, audits/inspections, automation, patients’ views, the SME (Small & Medium-sized Enterprises) pharmaceutical industry’s perspectives and innovative business models, I too had an opportunity to elucidate on my favourite topic “Pharmacovigilance as a Value Addition to the Global Pharmaceutical Industry” (which was previously published as a full-fledged article in Express Pharma, a leading Indian pharmaceutical industry news portal). The day turned out to be phenomenal not only in terms of the conference attendance but much more in terms of the knowledge-sharing that happened. Back in India, I had to swiftly switch over to the ‘Indian Pharmacovigilance Day‘ mode, for finalising the Agenda and the Speakers for the second edition of this conference which is scheduled to be held at Hyderabad on 28th July 2017. The astounding success of the previous edition held at Mumbai in 2016 has raised the expectations for 2017, especially because this is the first major and exclusive pharmacovigilance event to have been organized in Hyderabad in the past few years. Given the fact that Hyderabad is a global hub for both pharmaceutical manufacturing and pharmacovigilance operations; and with news of the revised draft of the ‘Pharmacovigilance Guidelines for Marketing Authorization Holders of Pharmaceutical Products in India’ being close to finalization by the Indian regulatory authorities, this conference aspires to augment the understanding levels of pharmacovigilance in this part of the country. Accordingly, the topics have been handpicked to be of relevance to all such stakeholders, for whom awareness about pharmacovigilance is now a compelling need. In this context, I am glad to share that popular 120 of 328


pharmaceutical industry news portals Express Pharma, Life Science World and CIMS Medica have published news on the Indian Pharmacovigilance Day 2017. Regarding the delegate registration charges for the Indian Pharmacovigilance Day 2017 conference, I wanted to keep you posted that EasyB has planned to implement the last minute/spot fee from 22-July-2017 which shall be 20% higher than the present fees. Hence, it may be beneficial to make your registrations on or before 21-July-2017. Please visit the URL https://www.townscript.com/e/indian-pharmacovigilance-day-2017-400412/booking for online registrations and payments. Last but not the least, I wanted to share two India regional reports authored by renowned pharmaceutical physicians Dr Sanish Davis and Dr Suresh Menon, and published in DIA’s Global Forum magazine, which I had the honour of editing in my honorary role as the ‘Regional Editor, India‘ since April 2017. The report titled ‘RARE DISEASES: Challenges and Opportunities in India for Medical Product Development‘ by Dr Davis was published in the April 2017 edition and the report ‘Clinical Research in India: Swing of the Pendulum‘ by Dr Menon was published in the July 2017 edition. I hope you enjoy reading these articles and look forward to receiving your feedback. Waiting to re-connect with you through our July 2017 newsletter,

Oviya MedSafe – Negotiating the Paradigm Shift in Pharmacovigilance Outsourcing July 2017 Dear Well-wishers, It is with tremendous jouissance that I publish this July 2017 edition of Oviya MedSafe’s newsletter, following the grand success of the Indian Pharmacovigilance Day 2017 conference that I chaired at Hyderabad on 28-July-2017. Organized for the second time in India by Italybased EasyB Srl renowned for their ‘Pharmacovigilance Day‘ series of conferences they conduct in several parts of the world, the event was locally coordinated in India by VHEO Ventures, an event management firm. Oviya MedSafe was a proud sponsor of the event. The conference began with the video welcome address of EasyB’s Managing Director Mr Enrico Pedroni and went on to deliberate on several aspects of relevance to Pharmacovigilance and India, harnessing the knowledge and experience of the distinguished speakers and panellists, whom I wish to sincerely thank from the bottom of my heart, for making this conference impactful with their active involvement. A detailed post-event note was published by Express Pharma, a media partner of the conference. The event had a good number of delegates from industry, academia and the student community. The complete set of 100 photographs clicked at the conference is available for public viewing and/or downloading from this link. 121 of 328


I had an enjoyable opportunity of moderating a colloquium titled ‘Operational Excellence in Pharmacovigilance Outsourcing – Pros & Cons’ as part of this conference. While preparing for the session, I could not help wondering at the metamorphosis that the global pharmacovigilance outsourcing industry in India has undergone over the past decade. I also reflected upon the evolution of Oviya MedSafe as a provider of global Pharmacovigilance consulting & Drug Safety services, since Oviya MedSafe’s founding in 2012. I realized that a key reason for Oviya MedSafe’s achievements was that we were able to foresee and were ready to negotiate the paradigm shift that the industry was to see in due course. Centralizing global pharmacovigilance operations in India, either in an in-house model or by having a service-provider as a partner, has been proven to be rewarding for most pharmaceutical companies especially in terms of the quick scalability required to manage their increasing workloads and the attractive cost-effectiveness needed to retain their intended profit margins, among other assessment parameters. While most of the leading global innovators set up pharmacovigilance operations in India by forming strategic relationships with service-providers, Indian multinational generic pharmaceutical companies saw this as an opportunity to reclaim their global pharmacovigilance operations from their service-providers whose operations were based in the regulated markets in which the generic companies were marketing their products. The scenario further changed with other business models also coming into the picture. Some global innovators set up their captive pharmacovigilance units in India and kept these units as services subsidiaries totally disconnected from their product-selling legal entities in India. This approach, to a great extent, helped them counter the headcount limitations they had with the latter. Another development was that many of the Indian generic companies began to disbelieve in outsourcing, given the fact that outsourcing within India was not much less expensive for them in comparison with their global counterparts. Nevertheless, with more and more of the small & medium-sized Indian pharmaceutical firms expanding their businesses to regions which started mandating pharmacovigilance, the domestic businesses of Indian pharmacovigilance serviceproviders continued to grow too. Inquiries for more cost-effective pharmacovigilance software databases and related technology enhancements emerged. Marking an end of a full circle, we see today that not all pharmaceutical companies (particularly in the generic segment) have succeeded with the in-house model. In fact, all the stakeholders seem to have started understanding that the traditional horizontal departmental approach followed in large manufacturing companies is probably not in cultural synchronization with the verticalfocused competitive operational environment found in the service-providing companies in the pharmacovigilance domain. I see this as an extrapolation of the concept that the reasons for pharmacovigilance outsourcing have begun to move from ‘more financial’ to ‘more strategic’. Given this mindset change happening across the pharmacovigilance domain, especially in a large pharmaceutical market like India where domestic pharmacovigilance obligations for pharmaceutical companies are already in vogue and are shortly expected to be formalized in a more structured manner, we at Oviya MedSafe believe that pharmacovigilance outsourcing will 122 of 328


continue to remain relevant for a client-focused boutique consultancy like ours and look forward to expanding our scope of services to include futuristic pharmacovigilance offerings, which I hope to explain on another occasion. Looking forward to meeting you through our August 2017 newsletter, Oviya MedSafe – Enhancing Mentorship in Global Pharmacovigilance August 2017 Dear Well-wishers, As I begin to pen this August 2017 edition of Oviya MedSafe’s newsletter, I cannot but help admire the essence of the 399th couplet of ‘Thirukkural‘ (a Tamil classic written two millennia ago by Thiruvalluvar – a universal philosopher who defined the morals for many contemporary concepts of practical life, in just 1330 couplets), which I opt to elucidate as below in translation, claiming due contextual liberty: “On seeing a world that gets enlightened by (their enthusiastic practice of) the conscientious learning which made them learned, the learned ones fall deeper in love with their chosen subject.” Although I have known this couplet since my childhood, I absorbed its complete message only recently, when I travelled to Dubai along with three of my colleagues to conduct a customized two-day training programme / workshop on pharmacovigilance, for a pharmaceutical company based in Middle East Asia. Being one of the largest & fast-growing drug marketers in the region, they were keen to understand not only their local pharmacovigilance requirements but also those of the key global markets. It was a rejuvenating experience for us as we taught, trained, discussed, clarified, tested, evaluated and thereby empowered the trainees (who happened to be experienced professionals from medical/regulatory/sales functions) within two days. We realized what it was to be able to initiate the pharmacovigilance journey for emerging regions and felt proud at the positive feedback we received. Oviya MedSafe has conducted comprehensive corporate training sessions for multinational pharmaceutical companies in the past too. We also had opportunities to organize standalone narrative-writing workshops in Coimbatore & Bengaluru, a post-conference workshop on narrative-writing in Singapore, and a One-Credit Course for Biotechnology students as an ongoing Industry-Academia collaboration activity, all of which were detailed in our December 2016 newsletter. In fact, we went on to partner with an event management firm to deliver a 2-day workshop at Coimbatore to commemorate Oviya MedSafe’s 5th Anniversary in March 2017. In line with these milestones, our Dubai workshop joins as the latest edition, with some more countries being anticipated in the future. I am delighted to share with you some pictures from the two-day event at Dubai.

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On a related note, I wanted to share with you that I was invited as Guest of Honour to the 14th STARS (Sri Subbaraya Setty Teacher and Research Students Awards in Pharmaceutical Sciences) Award Ceremony organized at Bengaluru on 12-Aug-2017, by the American Association of Government College of Pharmacy (Bengaluru) Alumni based in New York [AAGCPA], USA. I had a chance to provide a quick overview on Pharmacovigilance, to the audience which consisted of teachers and students of Pharmacy. Padmashree Awardee Prof Dr V Prakash (President, International Society for Naturals, Nutraceuticals & Nutritionals) was the Chief Guest of the function which was conducted by Dr G Jagadeesh, Scientific Coordinator of AAGCPA, USA. Dr Sunil S Jalalpure (Professor, Department of Pharmacognosy, KLE University’s College of Pharmacy, Belagavi, Karnataka) was the recipient of the STARS Award 2017 for Teachers for ‘Excellence in Academic Research‘. Please click here to view some snaps clicked at the programme. I wish to conclude this month’s newsletter edition with a personal good news: I have been nominated as the Chairman of the Pharmacovigilance Standing Committee of the Indian Medical Association – Tamil Nadu State Branch, for the year 2018! I wish to express my thanks to the incoming President Dr J A Jayalal, for conferring this honorary position upon me. In this new role, I look forward to doing my best to begin making Pharmacovigilance an integral part of Medical Practice in the state, with all of your encouragement, co-operation and support. Looking forward to connecting with you through our September 2017 newsletter,

Oviya MedSafe & Indian Pharmacovigilance Guidance for Industry September 2017 Dear Well-wishers, I am delighted to connect with you through this September 2017 edition of Oviya MedSafe‘s newsletter, which intends to focus on a landmark achievement in the history of pharmacovigilance in India, namely the release of the Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products, by the Secretary, Ministry of Health and Family Welfare, Government of India, on 29-Sep-2017. In this context, I wish to recall Oviya MedSafe’s pioneering work not only in advocating regulatory pharmacovigilance obligations for the Indian pharmaceutical industry but standing by the industry in support too, by providing India-specific pharmacovigilance support services ever since 2013. The pharmacovigilance guidance document was developed by the National Coordination Centre of the Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission, in collaboration with the Central Drugs Standard Control Organization (CDSCO), in order to ensure smooth functioning of pharmacovigilance activities by the pharmaceutical industry, with an aim to establish and ensure an effective pharmacovigilance system at their site according to the recent amendment in the Drugs & Cosmetics Rules, 1945, Schedule Y vide Gazette Notification G.S.R. 124 of 328


287(E) published on 08-Mar-2016. A number of prominent professionals from the industry, including me, shared with PvPI their insights and feedback on this document prior to its finalization, on their invitation. For the purpose of this guidance document, the term MAH refers to the manufacturer or the importer of the drug who has a valid manufacturing or import license. The scope of the guidance document includes all drugs, biologics, radiopharmaceuticals and phytopharmaceutical products but excludes veterinary products and medical devices. The Pharmacovigilance Guidance Document comprises of the following modules: # MODULE 1 – Pharmacovigilance System Master File (PvMF) # MODULE 2 – Collection, Processing & Reporting of Individual Case Safety Reports # MODULE 3 – Preparation & Submission of Periodic Safety Update Reports # MODULE 4 – Quality Management System at the MAH Organization # MODULE 5 – Audits & Inspections of the Pharmacovigilance System at the MAH Organizaliion # MODULE 6 – Submission of Risk Management Plans With the guidance document all set to be effective from January 2018, it is imperative for all Indian MAHs to ensure that they are in compliance with the requirements laid out in all of the above six modules. Oviya MedSafe has always been vocal about having well-defined pharmacovigilance regulations for India and has documented the dire need in articles, opinion pieces, editorials, conference presentations, media interviews and the past editions of our newsletter (particularly June 2015, Feb 2016 and Oct 2016 editions). Further, we promptly responded to industry needs by introducing India-specific pharmacovigilance services even when such a detailed guidance document was not available. Hence, it is our honour to re-dedicate ourselves to the domain of pharmacovigilance, on this positive occasion. On a related note, I am happy to share with you that key experts are all set to discuss the pharmacovigilance guidance document, among other topics, in the forthcoming 4th National Pharmacovigilance Symposium of the Indian Society for Clinical Research, which is to be held at Hyderabad on Saturday 28-Oct-2017. The detailed agenda is to be uploaded shortly. I take this opportunity to invite you to register for this symposium and get benefited. For more information, please contact ISCR Secretariat. Before I end, I wanted to share with you a few snaps from the 2nd International Pre-Conference Workshop on Pharmacovigilance conducted by Anurag Group of Institutions, Hyderabad in which event I participated as the Chief Guest on 15-Sep-2017 and delivered the inaugural address. Oviya MedSafe and Indian Pharmacopoeia Commission were collaborators with Anurag Group for this event. 125 of 328


Wishing you a very Happy Deepavali and waiting to write our October 2017 newsletter,

Oviya MedSafe – Batting for Pharmacovigilance Independence October 2017 Dear Well-wishers, Just as cricketers bat for their teams and as their fans bat for their favourite players, I was tempted to bat for ‘Pharmacovigilance Independence’ when I sat to put together my thoughts for this October 2017 edition of Oviya MedSafe‘s newsletter! Of course, independence is something that everyone ‘wants‘. But, why does Pharmacovigilance ‘need’ to be independent? The obvious answer would be that Pharmacovigilance deals with lives and therefore should be devoid of interference from any other domain. A quick sub-query might be on what independence will mean in this context. Let us try to resolve the puzzle together, having in mind the general scenario in the pharmaceutical industry! To start with, having an exclusive Pharmacovigilance department in a pharmaceutical company may itself be considered by some as independence, as the head of the department may have dedicated staff and may get to directly report to the top management. However, this is far from reality because Pharmacovigilance is an interdisciplinary function and in fact, it is difficult for routine Pharmacovigilance activities to be performed without the involvement and rather the cooperation of other departments. Moreover, decision-making in Pharmacovigilance matters doesn’t always rest with the department alone due to the business-critical nature of some decisions in which other departments such as Manufacturing/Marketing/Regulatory Affairs may even have a stronger say. In fact, even this limited degree of independence can be said to exist only when the top management encourages the Pharmacovigilance department to make unbiased recommendations on the safety of their products without hesitation, before a corporate decision is made. Moving to the next level, independence may be seen as the capability and the authority available with the Pharmacovigilance department to be emphatic in documenting and appropriately acting upon a potential harm identified to be associated with their company product, overriding all other interests. In the real world, this is not impossible but many a time difficult. The strength of the Pharmacovigilance department’s argument for ‘Patient Safety‘ and the dynamics of power in the concerned organization are important determinants of the level of independence that could be achieved. Whether the company product is in the clinical trial stage or in the post marketing stage is another factor that may come to play. Similarly, the ‘innovative‘ or ‘generic’ categorization of the company itself may influence the level of independence to a great extent. 126 of 328


While it is true that the autonomous and controlling role played by regulatory agencies insulates the Patient Safety risk due to the total or partial lack of ‘Pharmacovigilance Independence‘ in the industry, it is important for the industry to grant the due independence to Pharmacovigilance. I tend to think that the pharmaceutical industry can best achieve the highest level of ‘Pharmacovigilance Independence‘, in all good sense, by externalising Pharmacovigilance from their core business focus. Having a knowledgeable, reliable and durable ‘Pharmacovigilance Partner‘ may be of immense support to a pharmaceutical company especially when its internal Pharmacovigilance department is held back by its unknown fears. I believe it may be appropriate at this juncture for me to recall Oviya MedSafe’s July 2017 newsletter edition, in which I had traced the life cycle of ‘Pharmacovigilance Outsourcing‘ and highlighted how Oviya MedSafe has been negotiating the paradigm shift in this field. I wish the act of batting for ‘Pharmacovigilance Independence‘ could be seen as extrapolation of the defining work Oviya MedSafe has done in Pharmacovigilance since 2012. Standing testimony to this assertion is our long list of clients who have implicit trust in our commitment to them, which in turn drives us to always go at least one step higher than just satisfying their business needs. With more independence, we have always been more responsible, and that makes everyone at Oviya MedSafe proud of ourselves as a team! Looking forward to share more thoughts with you in November 2017,

Oviya MedSafe for PvOIs of Indian MAHs – Pharmacovigilance Training & Certification Workshops November 2017 Dear Well-wishers, I am proud to present this November 2017 edition of Oviya MedSafe’s newsletter, which aims at introducing to you one of our key initiatives for the year 2018 – a series of one-day intensive training & certification workshops exclusively for Pharmacovigilance Officers In-charge (PvOIs) of Marketing Authorization Holders (MAHs) of pharmaceutical products in India! As explained in the September 2017 edition of our newsletter, the recently released Pharmacovigilance Guidance Document for MAHs of Pharmaceutical Products is set to be effective from January 2018. According to this document, the term MAH refers to a manufacturer or an importer of a pharmaceutical product who has a valid manufacturing or import license in India. One of the most salient features laid out by this document is the requirement for a named PvOI, which aspect is elucidated in Section 1.4.1 of Module 1, as below in verbatim: 127 of 328


“In compliance with Schedule-Y of Drugs and Cosmetics Act, 1940 and Rules, 1945, one qualified and trained personnel should be authorized by the company management as PvOI with responsibilities for dealing Pharmacovigilance (PV) activities at MAH’s organization. This PvOI should be a medical officer or a pharmacist trained in the collection and analysis of ADR (Adverse Drug Reaction) reports. PvOI shall be responsible for the following: – Development of training modules and organizing training for staff of PV department; – Identification of PV activities and framing of Standard Operating Procedures (SOPs), revision of SOPs; – Establishment & maintenance of the Quality Management System (QMS) of PV department; – The PvOI should reside in India and respond to queries of regulatory authorities whenever required. The information relating to the PvOI provided in the Pharmacovigilance System Master File (PvMF) shall include: • Contact details (Name, address, phone, e-mail); • Summary, curriculum vitae with the key information on the role of the PvOI; • A description of the responsibilities guaranteeing that the PvOI has sufficient authority over the PV system in order to promote, maintain and improve compliance; and • Details of duty-in-charge to work in the absence of PvOI.” With Oviya MedSafe having been active in the Indian pharmacovigilance compliance space since 2013, we are already aware that the pharmacovigilance expertise levels in Indian MAHs vary right from being regulatorily self-sufficient (typically in companies that market their products in regulated markets) to literally non-existent (often in companies that hold manufacturing licenses but seldom market their products even domestically). However, the above-detailed requirements for a PvOI, among all other pharmacovigilance obligations detailed in this document, will be applicable across all organizations that qualify to be MAHs as defined above. While Oviya MedSafe has an enviable track record of working with several clients to help them comply with their global pharmacovigilance obligations (including Indian) as an outsourced partner, we also realize that we should take ownership for building the capacities of our clients’ staff, especially the PvOI nominees so that they could perform their roles in line with the expectations of them. While thinking on these lines, I began wondering how Oviya MedSafe could extrapolate this capacity-building activity to the wider industry and ensure that as many Indian MAHs as possible could be benefited. It is then that the idea of conducting one-day intensive pharmacovigilance training & certification workshops exclusively for PvOIs emerged. I further believe that the certification associated with this activity will validate the training in the collection & analysis of ADR reports which is mandatory for PvOIs according to this document. Given this background, Oviya MedSafe is happy to announce that the first such one-day intensive training & certification workshop for PvOIs of MAHs will be conducted at Hotel Kohinoor Continental, Mumbai on Friday 12-Jan-2018. The workshop will be open only to official PvOI 128 of 328


nominees of Indian MAHs. The registration fee per participant has been fixed as INR 5000 + applicable taxes only, in order to encourage as many micro, small and medium-sized MAHs as possible to get their PvOIs trained and certified. For registration and/or more information, please contact Oviya MedSafe at +918220763222 and info@oviyamedsafe.com. We plan to conduct this workshop at other locations in India in quick succession to this one. Looking forward to meet you through our December 2017 newsletter soon, Oviya MedSafe welcomes 2018 – a Year of Hope for Pharmacovigilance December 2017 Dear Well-wishers, I begin this December 2017 edition of Oviya MedSafe‘s newsletter with my heartfelt wishes to you for a Happy and Prosperous New Year 2018! Every new year kindles new hopes for our future. In this context, 2018 is, quite literally, a New Year of New Hope for Pharmacovigilance in India, thanks to the recently announced pharmacovigilance requirements for the pharmaceutical industry, effective from January 2018. While this announcement may be viewed as a local regulatory development in India, it is important to note that it impacts all Marketing Authorization Holders (MAHs) of pharmaceutical products, which term implies every drug manufacturer/importer operating in the country. Further, with Indian pharmaceutical companies being global leaders in exporting pharmaceutical products to several countries and with India being a huge pharmaceutical market for most of the foreign pharmaceutical companies, the impact of these new requirements is expected to be far-reaching in the global compliance scenario too. Throughout the past 5 years, Oviya MedSafe has proactively been in the forefront of providing India-specific pharmacovigilance services, including focused pharmacovigilance support for Indian affiliates of foreign pharmaceutical companies. With all the accumulated expertise and our thorough understanding of the pharmacovigilance challenges faced by industry in India, we wanted to share our experience with MAHs while formally training and certifying their nominees for the role of ‘Pharmacovigilance Officer In-charge‘ (PvOI) which has been defined in the abovementioned Guidance Document as a medical officer or a pharmacist trained in the collection and analysis of ADR (Adverse Drug Reaction) reports. This larger thought resulted in the concept of ‘One-Day Intensive Training & Certification Workshops for PvOIs‘ which we had first spoken about in our November 2017 newsletter. 129 of 328


Our press release about our first workshop in this series (scheduled to be conducted at Hotel Kohinoor Continental, Mumbai on Friday, 12-Jan-2018) was featured extensively in Pharmabiz and in Express Pharma, for which we are very grateful to their editorial teams. We are delighted to state that the industry’s response to our approach has been very positive and we have just a few slots remaining before we reach our target of 50 delegates. If you are an official PvOI nominee (or their nominated back-up) of an Indian MAH and wish to register for this workshop through your organization, please contact Oviya MedSafe at info@oviyamedsafe.com / +918220763222. The registration fee per participant has been fixed as INR 5000 + applicable taxes only. The agenda and the registration form of the workshop can be downloaded from Oviya MedSafe’s downloads page. On a related note, I am delighted to share that my regional report titled ‘New Pharmacovigilance Obligations for MAHs in India‘ has been published in the just-released January 2018 edition of Global Forum, a publication of the Drug Information Association (DIA). As the India Regional Editor of this magazine, I have written this opinion piece as an independent review of the abovementioned Guidance Document. I am eager to hear your comments on this article. Please click on https://globalforum.diaglobal.org/issue/january-2018/new-pharmacovigilance-obligations-formahs-in-india/ to read the write-up and do share this link with anyone who may be interested. Before concluding, I wanted to highlight another event that I am personally associated with, namely the pre-conference workshop ‘Pharmacovigilance Audits and Inspections: Preparation to effective CAPA (Corrective And Preventive Action) development and implementation‘ that is to be conducted by the Pharmacovigilance Council of the Indian Society for Clinical Research (ISCR), on the eve of the 11th Annual Conference of ISCR, at Bengaluru. This first-of-its-kind workshop will be held on Thursday 18-Jan-2018 with Ms Sophie Keddie, Dr Chitra Bargaje, Dr Jamal Anwar Baig, Ms Nidhi Vaish and Ms Indu Nambiar, along with me, as the key faculties. For more information on the workshop as well as the conference, please visit http://www.iscr.org/iscr-conference2018/ and scroll down. It is possible to register for the pre-conference workshop alone too, in case you will not be able to attend the whole conference. Waiting to re-connect with you through our January 2018 newsletter,

Oviya MedSafe in Pharmacovigilance – Benefiting from an Unconventional Approach January 2018 Dear Well-wishers, With earnest thanks to 2017 that bestowed upon us some deserving accomplishments and with profound optimism that 2018 would bless us with greater laurels, I delightedly share with you this January 2018 edition of Oviya MedSafe’s newsletter! 130 of 328


Oviya MedSafe was founded in March 2012 with tremendous determination and zeal to be different from other global pharmacovigilance service-providers in the market; not because we too succumbed to the compulsive need to be seen differently. Rather, it was primarily because we understood that the available pharmacovigilance offerings were not in line with the business requirements of the majority of the target clientele. Therefore, we consciously chose this ‘Boutique Consultancy‘ model, in order to keep our services relevant to and affordable by small and mid-sized pharmaceutical companies situated in any part of the world. This model, which was then new among India-based organizations in the pharmacovigilance domain, was later explained in detail in Oviya MedSafe’s August 2016 newsletter ‘Oviya MedSafe in Outsourced Pharmacovigilance – Comprehensivising the Compartmentalised‘. Today, I am overjoyed to realize that most of Oviya MedSafe’s significant achievements as an organization can be mapped to the unconventional approach we adopted long ago. The holistic manner in which we perceived, percolated, practised and promoted pharmacovigilance over the years has given our team an integrated view of the discipline, which in turn, has positioned us as a perfect partner for clients that have a clear demand for such a capability. As a result, Oviya MedSafe has now evolved beyond the stage of merely helping pharmaceutical companies fulfil their global regulatory pharmacovigilance obligations to that of a novel firm that renders customized cutting edge functional consulting offerings in pharmacovigilance to a variety of clients from different domains. Of course, Oviya MedSafe owes a great deal of these strings of successes to our vibrant team members who have always been ready to follow us with trust whenever we drove through the roads seldom taken by others in the industry. Coming to updates on the ‘One-Day Intensive Training & Certification Workshop for Pharmacovigilance Officers In-charge (PvOIs)‘ conducted by Oviya MedSafe at Mumbai on 12-Jan2018, the event was well-attended by delegates representing several Indian Marketing Authorization Holders (MAHs). The proceedings of the day were appreciated by the PvOIs who found this workshop as an opportunity to discuss their queries and derive a common understanding on many issues they faced in the context of the New Pharmacovigilance Obligations for MAHs in India. As announced already, we wish to conduct this workshop in other Indian cities too. The date and venue of the next instance of this workshop will be publicized soon. Moving to pharmacovigilance from a medical practitioner’s viewpoint, I was triggered by a news report to write an article titled ‘Do adverse drug reactions always occur due to medical negligence?‘, which I thought would turn out to be an interesting read for you. I will be happy to hear your comments on this sensitive topic, which I wish to address in greater detail, as 2018 unfolds further, in my role as the Chairman of the Pharmacovigilance Standing Committee of the Indian Medical Association – Tamil Nadu State Branch. Last but not the least; I would like to take the pleasure of inviting you to register for DIA India’s 6th Pharmacovigilance Conference – Drug Safety Unplugged which is to be held on March 22 & 23, 2018 at Mumbai. As a Program Committee Member of this conference for the 3rd consecutive 131 of 328


time, I am privileged to have been asked to chair a key session and I hope to meet you at the conference. Looking forward to re-connect with you through our February 2018 newsletter,

Oviya MedSafe – Personifying Integrity in Pharmacovigilance February 2018 Dear Well-wishers, As we move further into 2018, I am immensely pleased to pen this February 2018 edition of Oviya MedSafe’s newsletter! This edition aims to dwell upon one of Oviya MedSafe’s core values, namely ‘deep-rooted business integrity‘. Integrity, at a personal level, could be defined as one’s strict adherence to a moral code, reflected in transparent honesty and complete harmony in what the person thinks, says, and does. At an organizational level too, the definition would remain pretty much the same, although achieving it might be much more difficult than it can be for an individual. While no organization would say that they do not value integrity and while many organizations explicitly claim to be high on integrity, the fact remains that only a few organizations have adequately and accurately imbibed the principles of integrity in order to practise it in thought, word and deed. Oviya MedSafe takes pride in being part of this league, thanks to integrity being an inseparable component of its roots. KTVR Vijaydeepa Group, the Coimbatore-based conglomerate that holds the majority shareholding in Oviya MedSafe, was built upon the personal values of integrity carried by its founder Mr K T Venkatarama Reddy, a self-made entrepreneur who transformed his name into a well-respected brand during his lifetime. Our minority shareholder Ma Foi is a globally renowned name for its integrity. In fact, the very meaning of the French word ‘Ma Foi‘ is ‘My Word‘. Standing on the shoulders of these giants, it is quite natural that Oviya MedSafe has a flair for integrity, which is evidenced by the repetitive engagements our clients have done with us in the past 6 years. As we all know, integrity is imperative in the pharmacovigilance domain. Throughout the life cycle of pharmacovigilance activities, especially in the industry, integrity has a key role to play. A single act of low integrity happening anywhere in the system may end up pulling down the system altogether. With quite a number of contract research organizations having earned dubious distinctions for being low on integrity, Oviya MedSafe aspires to stand tall as a lighthouse in practising global pharmacovigilance with uncompromising integrity levels, so much so that we have at times denied certain paid assignments despite our clients’ willingness to award them to us, for the simple reason that the said activity was not required for the particular client at that 132 of 328


point of time. Such a straight-forward approach has only brought us more and more business, as it has improved our trustworthiness as an organization. At Oviya MedSafe, integrity has always been important at all levels – beginning right from keeping the explicit and implicit promises we made to our clients as well as suppliers; to ensuring that all our team members absorb and emit our intensity of integrity. This organizational achievement has been possible only because we made a conscious decision as early as in 2012 (when we began our journey) to avoid all such unethical shortcuts even though they may have assured or even actually resulted in quick revenue. The bottom-line for us was, is and will be the fact that Oviya MedSafe is looking to be in pharmacovigilance, not just until it ceases to be a buzzword, but rather for life! To sum up, let me use the words of Donald A. Adams: “To give real service, you must add something which cannot be bought or measured with money, and that is sincerity and integrity.” I thank you for your patient reading and hope to meet many of you at DIA India’s 6th Pharmacovigilance Conference in which I am a Program Committee Member. Eager to speak to you again through our March 2018 newsletter,

Six Years of Oviya MedSafe & 72 Editions of Pharmacovigilance March 2018 Dear Well-wishers, At the time of the year when nostalgia gets the better of me, it is but natural that I tend to handpick and sew together some glittering pearls of wisdom which got scattered all along the path I travelled thus far. Yes – it is Oviya MedSafe’s anniversary again, now the sixth since the organization’s founding, with this March 2018 edition of Oviya MedSafe’s newsletter being the proud 72nd in the consecutive monthly series! Of course, six years mean a lot. Literally, in my mother tongue Tamil that is known for its homonyms among its many other virtues, the word for six is ‘Aaru‘. Interestingly, this Tamil word could also be used to imply a river, a path/way, one’s own home, or refer to the phenomena of healing, consoling, cooling down or strengthening someone/something. I am pleasantly surprised that Oviya MedSafe inherently relates to all these meanings of the word from a pharmacovigilance perspective, with the nouns defining who we are in pharmacovigilance and the verbs asserting the net effect of the pharmacovigilance fulfilment our customers experience by nature of choosing to work with us. Having begun our journey on a humble note on 14-Mar2012, I believe we have reached where we are now because Oviya MedSafe had always wanted to simplify the frighteningly complex pharmacovigilance, for our trusting clients.

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Indian pharmacovigilance has always been an intriguing topic for pharmaceutical professionals and public health researchers worldwide, thanks to the huge population of the country which by itself is expected to play the role of a deterrent. However, India has achieved quite a lot in pharmacovigilance, especially from the time the Pharmacovigilance Programme of India (PvPI) was initiated. I had the privilege of being interviewed by the renowned Dr Alberto Grignolo, Editor of Global Forum, a Drug Information Association (DIA) publication, on the topic ‘PvPI: Technology Meets Opportunity to Improve Safety‘ in which I shared my perspectives about the programme and the ‘Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products‘ which was made effective from January 2018. This audio interview was published as a podcast on DIA’s dedicated online platforms. Please do listen to the podcast by visiting the URL http://diapublications.podbean.com/e/pvpi-technology-meetsopportunity-to-improve-safety/ and feel free to share your views. I take this opportunity to thank Dr Grignolo and the DIA editorial team for having made this interview possible. On a related note, I was fortunate to be able to facilitate a ‘Question & Answer’ segment on the same topic with Dr V Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission (the officer-in-charge of coordinating the activities of PvPI) for the April 2018 issue of DIA’s Global Forum, in my honorary role as the ‘India Regional Editor‘ of the magazine. I express my sincere thanks to Dr Kalaiselvan for setting aside his time for this candid interaction. Please visit the URL https://globalforum.diaglobal.org/issue/april-2018/pharmacovigilance-programme-of-indiapvpi-qa-with-the-principal-scientific-officer-indian-pharmacopoeia-commission/ to read the Q&A. I solicit specific feedback on this feature as I trust it will help me plan future engagements. Before signing off, I wish to inform you that I will be conducting the Indian Pharmacovigilance Day 2018 conference as its Chair, for the third consecutive time, following the highly successful 2016 (Mumbai) and 2017 (Hyderabad) editions. This third edition of this conference will be held in Mumbai on 27th July 2018 (Friday). This event is a part of the ‘Pharmacovigilance Day‘ series of events that are organized in several parts of the world by Italy-based conference-producing company EasyB srl. Do stay tuned for more details. Waiting to re-connect with you through our April 2018 newsletter,

Oviya MedSafe – Facilitating US FDA Pharmacovigilance Compliance of ANDA Holders April 2018 Dear Well-wishers, While your words of acclaim continue to pour into my inbox to compliment Oviya MedSafe’s 6th anniversary which we celebrated last month, I am delighted to connect with you through this April 2018 edition of Oviya MedSafe’s newsletter! 134 of 328


Before getting into the subject, it may be relevant for me to highlight the fact that the European Union General Data Protection Regulation (EU GDPR) is to be enforced from 25-May-2018. The GDPR not only applies to organizations located within the EU but will also apply to organizations located outside of the EU if they offer goods or services to, or monitor the behaviour of, EU data subjects. It applies to all companies processing and holding the personal data of data subjects residing in the European Union, regardless of the company’s location. Being a compliance-conscious organization, we at Oviya MedSafe are very keen to ensure that our periodic communications are well within the law. Hence, Oviya MedSafe herewith makes an earnest request to all EU-based readers of our monthly newsletters to kindly respond to this e-mail in order to let us know that you are willing to receive such mailers from us beyond 25-May-2018 too, failing which we will not be able to share Oviya MedSafe’s monthly pharmacovigilance insights with you. Of course, we understand that this regulation impacts only our EU-based readers and those of our readers based in non-EU locations will continue to receive our communications until you choose to unsubscribe by following the instructions appended in our mailers. In case you have any concerns about this approach which we have adopted, please do not hesitate to let us know. Marketing their products in the United States (US) of America is one of the key aspirations any growing pharmaceutical company would have. This aspiration is primarily based on the fact that leading drug manufacturers based in countries like India make most of their profits from the US market. Hence, it is not surprising that the pharmaceutical industry is more inclined to spend for (or rather invest in) pharmacovigilance for US FDA compliance than for any other region. I had had the opportunity to cover such perspectives in greater detail in the invited article ‘Pharmacovigilance as a Value Addition for the Pharma Industry‘ which was published in November 2016 by Express Pharma, a leading Indian pharma industry magazine. Oviya MedSafe has been adept in providing end-to-end pharmacovigilance services for holders of US FDA approved Abbreviated New Drug Applications (ANDAs). The pharmacovigilance requirements mandated by US FDA for ANDA-holders and our innovative methodology in setting up and running a ready-to-use cost-effective pharmacovigilance system especially for micro, small & medium-sized companies were detailed in Oviya MedSafe’s November 2016 newsletter. While I was reflecting upon these points, I realized that it may be of great support to emerging pharmaceutical companies (current or future ANDA-holders) if we organized a workshop on US FDA pharmacovigilance compliance in the likes of the ‘One-Day Intensive Training & Certification Workshops for Pharmacovigilance Officers In-charge (PvOIs)‘ which we first conducted in Mumbai earlier this year to elucidate the new pharmacovigilance obligations for Marketing Authorization Holders (MAHs) in India. Given the fact that most of the current/future US ANDA-holders based in India would also fulfil the criteria for MAHs (which term implies ‘a manufacturer or an importer of a pharmaceutical product who has a valid manufacturing or import license in India‘, according to the Pharmacovigilance Guidance Document for MAHs of Pharmaceutical Products), we came to 135 of 328


believe that it may be prudent to combine the US FDA pharmacovigilance compliance component with the next edition of our training & certification workshops for PvOIs. Consequently, I am glad to announce that Oviya MedSafe will conduct ‘IndUS Drug Safety‘, a oneday workshop in which both the Indian as well as the US pharmacovigilance obligations for the pharma industry will be dealt with in detail. The event shall be held in Mumbai on Friday 29th June 2018. The registration fee per participant has been fixed as INR 6000 + applicable taxes only, in order to encourage as many micro, small and medium-sized companies as possible to get their personnel responsible for pharmacovigilance trained and certified by Oviya MedSafe. For registration and/or more information on this workshop exclusively meant for pharma industry delegates only, please contact Oviya MedSafe at info@oviyamedsafe.com or +91-82207-63222. On a different note, I am glad to share that the ‘Indian Pharmacovigilance Day 2018‘ conference which I am to Chair for the third consecutive time (as detailed in our March 2018 newsletter) has garnered a good amount of attention and already has expressions of interest for the registrations. This event shall be organized by Italy-based conference-producing company EasyB srl, at Mumbai on Friday 27th July 2018. Please keep watching the conference website for updates in the forthcoming weeks. Before signing off, I wanted to acknowledge and thank the Organization of Pharmaceutical Producers of India (OPPI) for having invited me to represent Oviya MedSafe as a company that provides pharmacovigilance services for Indian compliance, at their ‘OPPI Medical Forum 2018‘ that was held at Mumbai on 3rd May 2018. I had the opportunity to present on the topic and also the honour to share the stage with Dr V G Somani, Joint Drugs Controller (India), in the panel discussion that ensued. An added privilege I had during the same trip to Mumbai was to have been invited by Dr Urmila Thatte, Professor & Head of the Department of Clinical Pharmacology, King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College, Mumbai, to speak on ‘Life with Pharmacovigilance‘. The post-lecture interaction I had with the staff & students in the department was very interesting and resulted in quite a lot of mutual learning, which I attribute with thanks to Pharmacovigilance that chose me! Looking forward to meeting you in our May 2018 newsletter, Oviya MedSafe – ‘IndUS Drug Safety’ Initiative & Indian Pharmacovigilance Day 2018 Conference May 2018 Dear Well-wishers, I begin writing this May 2018 edition of Oviya MedSafe’s newsletter with the satisfaction that ‘IndUS Drug Safety’, our recently announced initiative aimed at demystifying the Indian and 136 of 328


the US FDA pharmacovigilance compliance requirements for the pharmaceutical industry, has picked up momentum resulting in delegate registrations flowing in for this day-long workshop which is to be held at Hotel Kohinoor Continental, Mumbai on Friday, 29th June 2018! While thanking leading pharmaceutical news portals Pharmabiz and Express Pharma for having published our press release on ‘IndUS Drug Safety’, I am happy to add that the detailed agenda of the workshop is now available. The agenda, along with the registration form, may be downloaded from Oviya MedSafe’s Downloads Page. For any more information, please do not hesitate to contact us at info@oviyamedsafe.com or +918220763222. At this juncture, I believe it may be relevant for me to briefly recall some of the unique approaches we adopted in 2012 which helped Oviya MedSafe metamorphose from its humble beginnings into an organization of pharmacovigilance excellence that it is today. Firstly, we decided to comprehensively train our carefully selected entry level staff in several aspects of pharmacovigilance for a period of three months (as against the industry average of about two weeks) before being entrusted with client work. This meant that we needed to invest a lot of effort in this direction but we were mentally prepared for it as we had made up our mind that the ’boutique consultancy’ model we adopted for our organization would succeed only if we developed our people without cutting corners. Secondly, we put in measures of checks and balances to ensure that the candidates were evaluated at every stage of their learning before moving to the next. This step helped us ensure that both the quality and the productivity of the team met our expectations. Thirdly, we consciously avoided the options of charging the trainees or extending staff augmentation services to other organizations, as an attempt to address our overheads. Rather, we made our team confident of themselves and assured them that they would continue to be part of Oviya MedSafe and keep growing in the organization provided they cleared their assessments without compromise. This gave rise to the work culture of our team members being strongly rooted to Oviya MedSafe, which meant that we would have very less need to hire candidates from other organizations. It eventually turned out to be true. I personally feel that our strong homegrown capacity-building capability is one of the key reasons for the dynamism Oviya MedSafe is recognized for. It is no wonder that Oviya MedSafe continued to gain mileage as an organization capable of providing several levels of structured customized training in pharmacovigilance, despite its exponential growth as a conventional provider of drug safety services as well. The quick thoughts I have jotted down above may mean more in the context of Oviya MedSafe’s August 2016, December 2016, May 2017, August 2017 and January 2018 newsletter editions which highlight Oviya MedSafe’s core values ‘continuous learning to empower clients’ and ‘perpetual capability-building‘. I encourage you to read these newsletter editions at your convenience which I am sure will make you want to register for ‘IndUS Drug Safety‘. I am excitedly looking forward to travel with my team to Mumbai to conduct this workshop.

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On another note, I am delighted to share some snaps from the ‘OPPI Medical Forum 2018’ event held in Mumbai on 3rd May 2018 in which I was an invited speaker and panelist. This event conducted by the Organisation of Pharmaceutical Producers of India gave me the honour of sharing the stage with Dr V G Somani, Joint Drugs Controller (India), in the panel discussion that ensued. Dr Deepa Arora (Lupin) and Dr Jamal Baig (MSD) were the other panelists in the session which was hosted by Ms Indu Nambiar (Boehringer Ingelheim) and Ms Sofi Joseph (Serdia). Please click here to view and/or download the photos. Before signing off, I wanted to reiterate that the 2018 edition of the Indian Pharmacovigilance Day conference which I am to Chair for the third time is being organized at Hotel Peninsula Grand, Mumbai on Friday, 27th July 2018. The agenda for this conference is under finalization and, as in the previous editions, this will have the Who’s Who of the pharmacovigilance domain across several organizations as speakers and panelists. Please keep watching the conference website for more information. I have also been asked by the organizers (Italy-based LS Academy, a business unit of EasyB srl) to inform my network that early bird discounts would be applicable for all registrations made before 30th June 2018. For further details, please contact EasyB at india@easy-b.it or +917598815311. Thanking you for your patient reading and waiting to meet you in June 2018,

Oviya MedSafe – Augmenting Synergies in Pharmacovigilance June 2018 Dear Well-wishers, I am overjoyed to connect with you through this June 2018 edition of Oviya MedSafe’s newsletter which bears the pride of being the 75th Issue in the monthly series I have been writing since the inception of the brand Oviya MedSafe in 2012. While this is an exciting moment for me as the Founder of the organization, I wish to humbly share the credit of the achievement of this milestone with all of you who have constantly encouraged me with your valuable feedback to my monthly mailers. The month of June 2018 was mind-boggling, thanks to our attempt at challenging ourselves with an exercise called ‘IndUS Drug Safety‘, a one-day workshop on Indian and US FDA pharmacovigilance compliance requirements for the pharmaceutical industry. The workshop, which had my team members along with me as the trainers, was well-attended. In fact, we were surprised to see not just the young professionals we intended but quite a number of industry leaders from several globally renowned organisations too, as part of the audience. We perceived this outcome as an implicit token of trust the industry gifted to Oviya MedSafe. To our delight, the perception was ratified by the unambiguous verbal testimonials delivered by the participants at the end of the day. 138 of 328


During the sessions, we realized that there are differences in the ways each company approaches pharmacovigilance compliance, even in the context of well-regulated markets like the United States (US). While the norms may be clear, there may be more than one right way of performing the activities linked to them. Most of such specific directions adopted by companies were resultants of company conventions written secondary to audit or inspection findings. Of course, a one-size-fits-all approach may not work because the product portfolios as well as the circumstances under which each company was audited or inspected were widely different from each other. Moreover, the organizational structure of each company especially that of their pharmacovigilance system, plays a major role in devising such company-specific conventions. However, there was consensus among all the participants that global regulatory agencies do understand such differences and are, by and large, convinced as long as regulatory obligations are fulfilled and a proper justification (with proof of the effort invested) exists for any approach adopted by an organization. The intense cross-learning that happened during the workshop immensely benefited the attendees per their own words, while validating the success of Oviya MedSafe’s self-challenge. To view the photographs clicked at ‘IndUS Drug Safety‘, click here. On a related note, I wanted to share with you that my interview titled ‘Pharmacovigilance guidance document should be made part of D&C Act to ensure 100% compliance of drug industry: Expert‘ was published on 21st June 2018 in Pharmabiz, a leading pharma industry magazine in India. This interview gave me an opportunity to firmly express my independent views on the dire need to render more power to the recently-introduced Indian pharmacovigilance obligations for the pharma industry. I eagerly look forward to your comments in response to this interview and brainstorm on what more could be done in this regard. As a matter of fact, the concepts I had highlighted in the interview influenced to a great extent the agenda of the ‘Indian Pharmacovigilance Day 2018‘ conference which I will be chairing. The conference which is to be held at Mumbai on 27-July-2018 has an India-specific session that deals with the guidance document, clinical trial safety updates and the future of the outsourced pharmacovigilance industry. A unique ‘Literature Symposium‘ has been planned to provide a complete overview of literature monitoring activities for pharmacovigilance. Another session deals with core pharmacovigilance practices, covering Signal Management, Risk Management and the role of Medical Writing. Over and above all of these, we have two distinct experience-sharing keynote addresses. I trust attending this conference would serve as a great opportunity to listen to and directly interact with distinguished speakers. Before concluding, I wish to pass on some administrative information I received from Italybased EasyB srl, the organisers of the ‘Indian Pharmacovigilance Day 2018‘ conference. Please note that the conference venue has been changed to Hotel Kohinoor Continental, Andheri (E), Mumbai. For online registration, the link https://www.townscript.com/e/indianpharmacovigilance-day-2018 may be used. Registration before 20th July 2018 will be cheaper. 139 of 328


Over and above this timeline-based benefit, discounts are available on group bookings as well. For offline registration or for any other queries, EasyB’s Indian partner agency VHEO Ventures may be contacted on +917598815311 and/or india@easy-b.it. Looking forward to write to you in July 2018, Oviya MedSafe – Exemplifying Versatility in Pharmacovigilance July 2018 Dear Well-wishers, I begin writing this July 2018 edition of Oviya MedSafe‘s newsletter with limitless exuberance, thanks to the grand success of the third consecutive annual Indian Pharmacovigilance Day conference that was organized under my chairpersonship at Mumbai on 27th July 2018. Organized by Italy-based conference producer LS Academy (a business unit of EasyB srl), the conference had renowned pharmacovigilance professionals sharing their experiential wisdom with the enthusiastic audience. Please refer to the news reports published by Express Pharma and Pharmabiz for more details of the day’s proceedings. To view/download the official photographs of the conference, kindly click here. While reflecting upon two major aspects the conference was applauded for, namely the wide variety of topics covered in a single day and the integrated approach adopted towards the discipline of pharmacovigilance, I realized that I had probably subconsciously built the agenda as a corollary to how Oviya MedSafe got structured over the past six years as a ‘go-to’ organization for pharmacovigilance. It is unsurprising given the fact that Oviya MedSafe’s clientele has invariably been diverse in parameters such as company size, kind of products, scientific temper, type of licenses, marketing authorization status, country of origin, regulatory norms to be complied with, and so on, which has, in turn, played a significant role in the metamorphosis of Oviya MedSafe to what it is today – an exemplification of a versatile organization that provides comprehensive pharmacovigilance services to the pharmaceutical industry. In support of this seemingly tall claim, this newsletter edition intends to showcase the heterogeneity of Oviya MedSafe’s clients and indicate how each category of clients had different needs as follows: • Multinational Pharmaceutical Innovators: Oviya MedSafe has a rich history of working with five of the top twenty multinational pharmaceutical innovators. Writing subject narratives for Clinical Study Reports, providing end-to-end support for local affiliates, processing Individual Case Safety Reports (ICSRs), delivering corporate training to pharmacovigilance as well as non-pharmacovigilance staff, and performing local literature monitoring are some of the activities we have carried out on behalf of clients who fall under this category. 140 of 328


• Global Generic Pharmaceutical Companies: Clients that fall under this category are not innovators but are those which sell their generic products in several countries. Oviya MedSafe has such clients from many parts of the world and has garnered extensive experience in setting up end-to-end pharmacovigilance activities including drug safety software database deployment for such clients, for both regulated and semi-regulated markets. Most of the Global Literature Monitoring, Aggregate Reporting and the Risk Management parts of Oviya MedSafe’s repertoire of services have been delivered to this category of clients. Further, Oviya MedSafe has prepared Pharmacovigilance System Master File (PSMF) and, in the past, Detailed Description of Pharmacovigilance System (DDPS) too, for clients in this category to submit in different countries with varying pharmacovigilance requirements. • Drug Manufacturers with Marketing Partners: In countries like India, the holder of a manufacturing license or an import license is responsible for pharmacovigilance compliance. Although the Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products labels the above-mentioned manufacturers/importers as MAHs, it is a misnomer in many cases, as there are several companies which only manufacture finished products under their own licenses. Their products are procured vide business agreements by other pharmaceutical companies which in turn engage in marketing the products. In such scenarios, the client’s understanding of pharmacovigilance would usually be suboptimal and the budgets meagre. Oviya MedSafe has been recognized by such clients as a knowledgeable, trustworthy and cost-effective pharmacovigilance partner. • Drug Distributors in Different Countries: Oviya MedSafe has a good deal of experience in addressing the pre-approval/post-approval pharmacovigilance consultancy needs of drug distributors (sometimes known as Local MAHs) in countries where the manufacturers or the main MAHs did not have direct presence. Interaction with Qualified Persons for Pharmacovigilance (or QPPV equivalents known by different names in emerging markets) who would take care of the local liaison was a critical part of the activity. Establishing pharmacovigilance quality assurance systems and performing gap analyses of such systems were significant specialized services rendered to clients who fell under this category. Providing pharmacovigilance training to such QPPV equivalents also formed a key part of the business engagements with such clients. Onsite training sessions in foreign locations have also been conducted by Oviya MedSafe in more than one occasion. • Producers of Biologics/Vaccines: Oviya MedSafe has been having its share of carrying out pharmacovigilance activities for niche products like biologics (including biosimilars) and vaccines, with regulatory reporting facilitated for many countries. • Technology Firms: With technology having proven itself as an enabler of continuous and incremental advancements in pharmacovigilance, Oviya MedSafe has began supporting this novel category of clients with functional consulting from a futuristic perspective. What has made Oviya MedSafe triumphant in all engagements we have had with any client of ours is our strict adherence to the applicable written procedures. In fact, I am proud to mention that we have used our own Standard Operating Procedures (SOPs), Work Instructions (WIs) and Guides for most of our clients. Thanks to our robust and proactive Quality Assurance department, Oviya 141 of 328


MedSafe has always been inspection-ready and has cleared external audits with ease. In short, the broad acceptance of Oviya MedSafe’s ready-to-use pharmacovigilance system by our clients is a result of our meticulous teamwork overarched by our unflinching commitment to attaining the peak of domain excellence. While we have indeed come a long way as a boutique pharmacovigilance consultancy enriching our long list of clients all along by epitomizing our multi-pronged approach, I believe it is time to consider shifting our goalpost. I trust that not only Oviya MedSafe but also our future clients will benefit a lot if we express our expertise at a much larger scale by growing our team. To pursue this self-set growth target, Oviya MedSafe has started contemplating on whether venture capital investments could be accepted, which is a topic I may write in detail sometime in the future. I thank you for your patient reading and wish to hear your feedback on this letter. Looking forward to re-connecting with you in August 2018,

Oviya MedSafe – Spearheading Advocacy for Translational Pharmacovigilance August 2018. Dear Well-wishers, I would like to start this August 2018 edition of Oviya MedSafe‘s newsletter with my usual ebullience, albeit on a little unconventional note, thanks to some interesting conversations I had with new members who joined Oviya MedSafe at entry level positions recently. While each individual gave a different answer to my favourite question on why they chose pharmacovigilance as their career, one of them emphatically stated that they did so because pharmacovigilance gave them an opportunity to be of humanitarian service to the society. While every person’s answer was relevant in some way or the other, this responsible perspective of visualizing pharmacovigilance as one’s commitment to the community at large instantly appealed to me and led me to recall how Oviya MedSafe has been spearheading advocacy for ‘Translational Pharmacovigilance’ without looking at the domain of pharmacovigilance only as a business vertical, ever since the founding of the organization in 2012. At this juncture, it may be useful for us to review the meaning of the term ‘translational‘ in the context of ‘Translational Medicine‘. The European Society for Translational Medicine (EUSTM) defines in this publication that Translational Medicine is an interdisciplinary branch of the biomedical field supported by three main pillars: benchside, bedside and community. It goes on further to state that the goal of Translational Medicine is to combine disciplines, resources, expertise, and techniques within these pillars to promote enhancements in prevention, diagnosis, and therapies. It is not difficult to extrapolate these principles to pharmacovigilance, as the primary purpose of pharmacovigilance is to protect the consumers of medicinal products. In fact, 142 of 328


Translational Pharmacovigilance may also be viewed as a part and parcel of Translational Medicine. While on this topic, it may be pertinent for me to highlight my invited lecture at TAPPCON 2018, the 4th Annual State (Tamil Nadu & Puducherry) Conference on Pulmonary Diseases organized recently at Coimbatore, India. While I have been speaking to clinicians on the topic of pharmacovigilance and persuading them to report suspected adverse drug reactions since 2010 (even when I had not founded Oviya MedSafe), TAPPCON 2018 is the first medical conference belonging to a speciality outside my own speciality of Diabetology to have me as an invited speaker. During my talk, I provided a quick overview of key pharmacovigilance activities that would be performed once a suspected adverse drug reaction gets reported. Earlier, my interview titled ‘Keep an eye on Indian drugs to prevent rare side-effects: Pharmacovigilance expert‘ was published in Chennai-based English daily newspaper ‘News Today‘ in which I touched upon the key aspects of pharmacovigilance as it is in India today and explained what the discipline deals with, for the benefit of understanding of people who are outside the pharmacovigilance domain. Please go through the interview and share your feedback, if any. As a milestone in my quest to unearth the benefits that Translational Pharmacovigilance could give to the society, I have been invited to moderate a colloquium session titled ‘Perspectives on Pharmacovigilance Awareness & Challenges in India‘ at the 5th Annual Pharmacovigilance Symposium of ISCR (Indian Society for Clinical Research) which is scheduled to be held at Mumbai on Friday, 28th September 2018. This session will exclusively focus on the views of the non-industry pharmacovigilance stakeholders in India, namely the medical practitioners, consumer groups, adverse drug reaction monitoring centres and pharmaceutical academia. As a doctor and as the incumbent Chairman of the Pharmacovigilance Standing Committee of the Indian Medical Association Tamil Nadu State Branch, it is my privilege to have Dr Ravi Wankhedkar, National President of the IMA (Indian Medical Association) as part of my session. The theme of this symposium is ‘Pharmacovigilance in India – Navigating the Transforming Landscape‘. To view/download the flyer with the agenda (as it is today) and to register for attending this symposium, please click on this link. Of course, there is a lot more to achieve in terms of making Translational Pharmacovigilance an absolute reality. But, the increasingly enthusiastic interest being shown by all the stakeholders promise that the journey ahead will be interesting and productive. Before signing off, I would like to share that I will be speaking at the ‘International Conference on Drug Development and Clinical Research: Current Scenario & Opportunities‘ which has been organized by Krupanithi College of Pharmacy at Bengaluru on 12th and 13th October 2018. I have also accepted to speak at the co-located ‘International Conference on Management 4.0‘ organized by Krupanithi School of Management on the same dates. I join the organizers of these conferences in inviting you to register yourselves as delegates. Looking forward to re-connecting with you in September 2018, 143 of 328


Oviya MedSafe – Pioneering Peerless Partnerships with MAHs for Focused Pharmacovigilance September 2018 Dear Well-wishers, As I begin this September 2018 edition of Oviya MedSafe’s newsletter, I am excited to share with you about two distinct professional privileges the month gifted me with, which I believe will have far-reaching impacts on my thought processes for a better pharmacovigilance scenario in India, from the perspectives of regulatory compliance for industry and that of advocacy for public health respectively. The first privilege was an opportunity to interact directly with the Indian Regulatory Authorities during a meeting called for by the Pharmacovigilance Division of the Central Drugs Standard Control Organization (CDSCO) on the subject of the ‘Pharmacovigilance System at Marketing Authorization Holders (MAHs) Site and Inspection‘. Leading an industry delegation, I presented the group’s views in this consultative meeting following which the Draft Pharmacovigilance System Inspection Guideline was unveiled. The document has been subsequently publicized and shall remain open for comments/suggestions from all stakeholders until 31st October 2018. The second privilege was being chosen to moderate a panel discussion featuring the renowned Prof Bejon Misra among other distinguished panellists. I conducted this vibrant session titled ‘Perspectives on Pharmacovigilance Awareness & Challenges in India’ at the successful 5th Annual Pharmacovigilance Symposium of ISCR (Indian Society for Clinical Research) at Mumbai. Having played a leading role in organizing all of the five annual pharmacovigilance symposia of ISCR since 2014, I felt this honour to be a vindication of my passion for pharmacovigilance. The photographs clicked at the symposium may be viewed/downloaded using this link. I had written at length about Oviya MedSafe’s specialized pharmacovigilance services for local affiliates of foreign multinational pharmaceutical companies, in our October 2016 newsletter. The edition highlighted how local affiliates function as strategic business units which carry out countryspecific activities of the company, while ensuring that they are aligned with their global policies. The specific pharmacovigilance requirements at a local affiliate level were listed and Oviya MedSafe’s expertise in providing customized Indian local pharmacovigilance compliance support was emphasized. I wish to re-visit this focused sector of Oviya MedSafe’s offerings in the context of the recent developments in the milieu in India, especially the Pharmacovigilance Guidance Document for MAHs of Pharmaceutical Products which has been made effective since January 2018. I had briefly reviewed this document as soon as it was released on 29-Sep-2017. Subsequently, I wrote a more detailed report for DIA’s Global Forum magazine (January 2018 edition) and was also interviewed by Pharmabiz magazine on 21-Jun-2018 on this subject. Oviya MedSafe conducted two instances of training programmes for Pharmacovigilance Officers in 144 of 328


Charge (PvOI) candidates of MAHs in January and June, both of which were well received. The implementation of the Guidance Document has resulted in an obvious increase of workload of Indian MAHs (which term includes any organization that holds a valid marketing or import license in India, whether it is an Indian/foreign headquartered company or has generic/innovative products), irrespective of the nature of the organizations. Oviya MedSafe has a proven track record of more than six years of delivering India-focused pharmacovigilance services with incomparably high quality levels in a very cost-effective manner, thanks to the robust written procedures we have in place for every activity we do. Although our core SOPs (Standard Operating Procedures) were designed having global pharmacovigilance practices in mind, we ensured that we then created specific work instructions and/or guides for supporting Indian MAHs with the local pharmacovigilance requirements laid out by the competent authorities. This has enabled us to support all Indian MAHs with the following activities, in addition to the services we were offering as of October 2016: # – Preparation of Pharmacovigilance System Master File (PvMF) for India; # – Training & Certification of PvOI candidates (general and company-specific); # – Establishment of a Pharmacovigilance Quality Management System (QMS); # – Consulting for Pharmacovigilance Inspection Readiness in the Indian context; and # – Authoring Risk Management Plans (RMPs) as and when requested by Indian authorities. We at Oviya MedSafe are proud of the long-term partnerships our clients, especially those for whom we provide India-specific pharmacovigilance services, have been having with us. We believe this is because of the unparalleled comfort levels they have with us, as they trust us completely. Oviya MedSafe too has gained greatly due to such alliances as they have resulted in further enhancement of our existing flair for teamwork, not only with our client representatives but also with their global pharmacovigilance service providers and other vendors, thereby guaranteeing a seamless coordination that can only be seen in a single team that works towards a common goal. On another note, I take the pleasure of inviting you to a conference titled ‘Clinical Research in Europe: What you need to know to successfully enter the EU Market?’ meant for pharmaceutical companies that intend to introduce their products in Europe. The conference, which is to be organized by Germany-based Lumis International and co-organized by Oviya MedSafe, shall be held in New Delhi on 15th November 2018 and will have me speaking on the topic ‘Product Safety Monitoring in Europe After Approval‘. Registration is free of cost, mandatory and is limited only to 50 participants. For more information, please download the conference brochure (with agenda) from Oviya MedSafe’s downloads page. Before signing off, I wish to share with you the regional report titled ‘India Perspective on Patient Engagement in Clinical Trials‘ written by Dr Chirag Trivedi (Director, Clinical Study Unit, Sanofi, India) for the September 2018 edition of DIA’s Global Forum magazine of which I am the honorary Regional Editor for India. I am sure you will enjoy reading this opinion piece as much as I did. 145 of 328


Eager to meet you through our October 2018 edition,

Oviya MedSafe – Cultivating Pharmacovigilance Standards Since 2012 October 2018 Dear Well-wishers, As I sit down to chronicle the October 2018 edition of Oviya MedSafe‘s newsletter, I am unable to help exclaiming about the variety of Pharmacovigilance angles the month subjected me to! On one side was KRUPACON 2018, a composite conference conducted by Krupanidhi Group of Institutions at Bengaluru, in which I had a chance to share my insights with Pharmacy and Management students separately. The inaugural function of KRUPACON 2018 bestowed upon me the honour of sharing the dais with Dr B Suresh, President of the Pharmacy Council of India (PCI), along with several other dignitaries from India and overseas. I spoke to Pharmacy students on the topic ‘Monitoring Product Safety Beyond Clinical Trials: Industry Practices‘. I trust my talk gave them a fair overview of what they could expect to do if they get to join the industry as Pharmacovigilance professionals in the future. In the co-located Management conference, I opined on the topic ‘Operational Disruptions in the Knowledge Industry‘. As an entrepreneur, I felt glad to have influenced the thought process of young Management professionals, especially with reference to the Knowledge Services segment under which Oviya MedSafe’s Pharmacovigilance offerings may be broadly categorized. Photographs of my participation in KRUPACON 2018 are available for viewing/download from this link. On the other side was my participation as a panelist at the ‘One Day Training Workshop on Good Clinical Practice (GCP) & Local Regulations for Clinical Trials‘ organized by Indian Society for Clinical Research (ISCR) & Coimbatore Respiratory Society (CRS) at Coimbatore, in which I was able to apprise a group of Clinical Investigators and other Clinical Research Professionals regarding the recent developments in the regulatory requirements pertaining to Pharmacovigilance in India. The workshop also gave me an opportunity to learn from the other Clinical Research experts who also spoke at the event. The fact that I was invited to speak at such an intense Knowledge Sharing event which was conducted at Coimbatore, the place where both Oviya MedSafe and I were born, rendered a special feeling to me. To view/download some pictures which were clicked at the workshop, please click here. While re-visiting these experiences, I feel that Pharmacovigilance, with its various forms, is relevant to several stakeholders in different ways. It also means to say that standardization of Pharmacovigilance (as an activity) needs to be done separately and uniquely for each stakeholder depending on the nature, depth, need, timelines and extent of their vested interest in the domain. For example, standardizing a Pharmacovigilance process that is carried out by the industry for regulatory compliance is dissimilar from doing so for a process pertaining to voluntary reporting of adverse events by a healthcare professional. To put it differently, the standards of assessment 146 of 328


should not be the same because we cannot assess apples against the standards set for oranges. I think it would be appropriate to elucidate this point further as the word ‘standards’ means different things for different people. Although it is generally used synonymously with ‘quality’, I personally feel ‘standards’ is the pedestal on which ‘quality’ is constructed. In other words, standards refer to the efforts and quality refers to the results. The higher standards we maintain, the higher quality we get. Not surprisingly, the Collins English Dictionary defines ‘standards’ not only as “criteria; a level of quality used to judge or compare something else” but also as “principles of propriety, honesty, and integrity” which vindicates my postulate. At this moment, I find it pertinent to mention that we at Oviya MedSafe, on our own, cultivated Pharmacovigilance standards for every activity that we have been involved in, right from our inception in 2012. As an organization providing global Pharmacovigilance consulting and Drug Safety services, Oviya MedSafe has always believed that the long-term success of any business entity depends on how it standardizes itself against the known standards in the industry. As the Founder, I have seen Oviya MedSafe growing not only by doing so but by also creating standards in certain aspects of our portfolio of services which were tailored for clients who had little prior understanding of Pharmacovigilance. The fact that we had internally resolved to treat every client of ours (irrespective of the maturity of their Pharmacovigilance understanding) equally, ensured that we set the highest quality target, namely 100%, more so for the clients who did not request for it. To achieve this quality, we standardized every process in the organization, both intrinsic and extrinsic, ranging right from the core departments of Pharmacovigilance and Quality Assurance to the entire set of support functions such as Business Development, Administration, Information Technology, Human Resources and so on. Thanks to our Quality Management System which has highly evolved over the past six and a half years, Oviya MedSafe possesses the ways and means to attain this stage. I would like to attract your attention to the February 2018 edition of Oviya MedSafe’s newsletter in which I had written in detail about how important Integrity is to Oviya MedSafe and of our July 2018 edition which explained how the robustness of our Quality Assurance function ensured Oviya MedSafe’s growth as a versatile organization supporting the Pharmacovigilance requirements of the global industry. I believe re-reading these newsletter editions from a causeeffect angle would further facilitate your comprehension and hopeful acceptance of this confident substantiation. I wish to thank you for your patient reading and welcome your feedback on this note. Waiting to re-connect with you through our November 2018 edition, Oviya MedSafe – Epitomizing Pharmacovigilance Entrepreneurship November 2018 Dear Well-wishers, 147 of 328


I pen this November 2018 edition of Oviya MedSafe‘s newsletter with an extra dose of fervour, thanks to a couple of new accolades the organization was honoured with at New Delhi during the month! On 15th November 2018, Germany-based Lumis International organized a conference titled ‘Clinical Research in Europe: What you need to know to successfully enter the EU Market?’ at India International Centre, New Delhi. The conference which was meant for pharmaceutical companies that intend to introduce their products in Europe had Germany-based eMQT, Netherlandsbased Salvius and Oviya MedSafe as co-organizers. The coming together of Oviya MedSafe with these three organizations was facilitated not only by our lines of businesses which complement each other but more so by the professional camaraderie I share with the my counterpart founders Heike Schoen (Lumis), Myrthe Trompert (Salvius) and Nancy Meyerson-Hess (eMQT). Heike, Myrthe and Nancy spoke on the Regulatory, Legal and Quality modules respectively. I took up the module on Drug Safety and Pharmacovigilance, in which I emphasized on the requirements for post-approval monitoring of product safety in Europe. The high point of the conference was the participation of Dr G N Singh, Secretary cum Scientific Director of the Indian Pharmacopoeia Commission (IPC) as the Chief Guest and Prof Bejon Misra, International Consumer Policy Expert as the Guest of Honour. During their keynote addresses, both the dignitaries shared their perspectives on the need for developing more expertise in Clinical Research and expressed their desire for fostering further collaborative ventures between the West and the East in this domain. Dr V Kalaiselvan and Dr Jai Prakash from IPC accompanied Dr G N Singh. Pictures clicked at the conference may be viewed and/or downloaded from this link. The bigger occasion of special recognition for Oviya MedSafe was on 16th November 2018 when I was invited to share my entrepreneurial experiences in Pharmacovigilance with aspiring entrepreneurs at the 1st Entrepreneur Development Programme on Pharmacopoeial and Pharmacovigilance Services organized by the Start-Up Cell of IPC at their office in Ghaziabad. The programme was inaugurated by Dr G N Singh and had dignitaries and other speakers from the CDSCO and the pharmaceutical industry apart from IPC. Being the only Pharmacovigilance entrepreneur invited by the Government of India to speak at the very first event of its kind, it was one of the greatest privileges not only for me but more so for Oviya MedSafe. I wish to dedicate this glory to my wonderful team members without whom Oviya MedSafe would not have reached this stage of being seen as a “Lighthouse of Pharmacovigilance” for the future generations of ‘Pharmacovigilantes‘. To view/download photos clicked at the event, please visit this URL. Before signing off, I would like to invite you all to register for the three-day 12th Annual Conference of the Indian Society for Clinical Research (ISCR) at New Delhi in which I will be the Workshop Lead of the pre-conference workshop ‘How the New Pharmacovigilance Obligations for MAHs in India may be fulfilled‘ that is scheduled to be held on 14th February 2019. Registration for the pre-conference workshop can be done separately or in combination with the registration for the whole conference. 148 of 328


Looking forward to connecting with you in December 2018,

Oviya MedSafe – Catalyzing Pharmacovigilance Compliance December 2018 Dear Well-wishers, As we begin our journey into 2019, I take great pleasure in wishing all of you and your families a very Happy & Prosperous New Year, through this December 2018 edition of Oviya MedSafe‘s newsletter! When I look back at 2018, I am glad that I had foreseen 2018 as a Year of Hope for Pharmacovigilance in India, as it indeed lived up to its expectations. Not only did the PV Guidance Document for MAHs (Marketing Authorization Holders) began to get adopted by the pharmaceutical industry in India, but it also led to the formulation of the Draft Pharmacovigilance System Inspection Guideline by the CDSCO on which feedback from several industry associations was also sought. Although the Indian Drug Manufacturers’ Association (IDMA) has represented its concerns on this inspection guideline, the fact that IDMA has only requested for phase-wise (staggered) implementation of pharmacovigilance inspections instead of a blanket waiver indicates that the industry also understands the need for a robust and integrated pharmacovigilance system in India. It is heartening to note that IDMA has raised a pertinent point of creating pharmacovigilance awareness amongst medical practitioners and encouraging them to report suspected Adverse Drug Reactions (ADRs). However, the apprehension that a vast majority of the industry is underprepared in terms of infrastructure, resources and knowledge required to comply with the new pharmacovigilance obligations, appears to be a little far-fetched, as it can be easily addressed by choosing an appropriate pharmacovigilance partner and leveraging their expertise. ime and again, Oviya MedSafe has proven to be a proficient, cost-effective and trustworthy pharmacovigilance partner to our diverse clientele located in several parts of the world in order to facilitate their pharmacovigilance compliance in a wide range of countries (regulated & semiregulated markets) in a comprehensive manner. In spite of being a versatile provider of centralized global pharmacovigilance services, Oviya MedSafe has always shown special interest in Indian pharmacovigilance compliance, which is vindicated by our close involvement in almost all of the pharmacovigilance developments in India since 2012. In fact, Oviya MedSafe has a history of swiftly deploying a complete pharmacovigilance system in terms of proprietary written procedures as well as a regulatory-compliant software database managed by an experienced team, exclusively for Indian compliance on par with global standards, from as early as 2015. Further, Oviya MedSafe has the pride of being the first organization in the country to conduct a 149 of 328


customized workshop and certify Pharmacovigilance Officers In-charge (PvOI) as soon as the PV Guidance Document for MAHs became effective in January 2018. It was followed by a variety of educational initiatives throughout 2018. Hence, I trust I am justified in claiming that Oviya MedSafe is best positioned to provide gold-standard India-specific pharmacovigilance services, with a global outlook, to the MAHs in India. “What exactly happens after a suspected ADR is reported to a pharmaceutical company?” is a question many students who aspire to be pharmacovigilance professionals had asked me in the past. I recently tried to answer the question by making a relevant presentation at a students’ conference. Thanks to an invitation from Ms Viveka Roychowdhury (Editor of Express Pharma); I could paraphrase the presentation as an article titled ‘Monitoring Product Safety Beyond Clinical Trials – Industry Practices‘ for the magazine. This article aims to provide an overview of the various pharmacovigilance processes in vogue in the industry without specific reference to the regulations of any particular/region. Please click here to read the article which I now realize would also answer a medical practitioner having the same question. As usual, I will be happy to receive your comments and/or suggestions, if any, in response to the article. While on this topic, I am delighted to share with you that I have been chosen once again by the Drug Information Association (DIA) as the ‘India Regional Editor‘ of their official publication ‘Global Forum‘, now for the period 2019-20. With thanks to the DIA for their reinforced trust in me, I take the privilege of presenting to you the most recent India regional report titled ‘Patient Engagement in India: Challenging Yet Worthwhile Road Ahead‘ by Dr Veena Jaguste who kindly accepted my invitation to write this opinion piece. Last but not the least, let me thank you for your patronage of the pre-conference workshop ‘How the New Pharmacovigilance Obligations for MAHs in India may be fulfilled‘ which is to be held on 14th February 2019, just ahead of the 12th Annual Conference of the Indian Society for Clinical Research (ISCR) on 15th & 16th February 2019 at The Eros Hotel, New Delhi. Being the Workshop Director for this pharmacovigilance workshop, I welcome you to New Delhi to listen to industry experts as well as regulatory officials on this critical subject. Although I would like you to attend both the pre-conference workshop and the main conference, please note that registering for the main conference is not a pre-requisite to register for the pre-conference workshop. Eager to meet you through our January 2019 newsletter, Oviya MedSafe – Uniting Physicians for Pharmacovigilance January 2019 Dear Well-wishers, With immense trust that the year 2019 is indeed treating you well, I am heartened to connect with you through this January 2019 edition of Oviya MedSafe‘s newsletter! 150 of 328


Although the word ‘treat‘ has quite a few meanings, its usage in the context of ‘medical treatment‘ assumes the greatest significance for patients and physicians alike. A physician may occasionally become a patient by chance but physicians are necessitated by design to play one of the following roles: (i) the Prescribing Physician (clinician) that prescribes medicinal products in order to provide medical care to the patient; or (ii) the Drug Safety Physician (pharmacovigilance professional) that assesses the benefitrisk balance of the prescribed medicinal products on an ongoing basis in the best interest of the patient. While prescribing physicians usually work in clinics or hospitals, drug safety physicians work not only in the pharmaceutical industry but also in governmental/international health agencies and academic institutions. Being key people on either side of the spectrum, physicians deal with quite a few issues pertaining to pharmacovigilance on a day-to-day basis. In this edition, I wish to share some of my thoughts on the divergent roles that are currently being played by physicians in pharmacovigilance and on why physicians have to come forward to unite for pharmacovigilance. For a prescribing physician, the priority would be treating the patient’s medical condition and therefore, a suspected Adverse Drug Reaction (ADR) is of importance only to the extent of its impact on the patient’s compliance with the prescribed treatment. However, for a drug safety physician, a suspected ADR is of primary importance as their mission is to ensure that the maximal therapeutic benefit of a prescribed treatment is passed on to the consumer, at the least risk. Having said so, we must remember that serious ADRs (especially fatal/life-threatening ones) critically affect prescribing physicians as they directly interact with patients and are expected to overcome the associated professional relationship issues and at times, medico-legal challenges also. On the other hand, drug safety physicians are seldom required to establish direct communication with consumers and they are in a position to critically analyze a wide range of ADR reports received from several prescribing physicians from different locations over an extended period of time. While a prescribing physician’s approach to the occurrence of a suspected ADR would be focused on providing appropriate medical treatment to the patient, a drug safety physician would try to understand why the suspected ADR occurred in the first place. In other words, a prescribing physician strives to “correct” while the drug safety physician aspires to “prevent“. The dissimilarities in the worlds of the prescribing physicians and the drug safety physicians often lead to the unfortunate scenario of one not fully understanding the professional goals, practical problems, regulatory/statutory obligations and so on of the other, thereby making ‘working in silos‘ the norm, in spite of the fact that both these physicians work for the benefit of the patient. The root cause for the development of this gap appears to be a lack of regular interactions between prescribing physicians and drug safety physicians rather than anything else. Although some amount of communication happens between these two physicians during the initial 151 of 328


reporting and the follow-up seeking stages of specific cases for purposes of regulatory compliance of the pharmaceutical industry, it does not reflect the plethora of pharmacovigilance benefits that the community could harvest if such interactions were more mainstream and possibly mandated by statutory bodies ably facilitated by physicians’ associations. In this context, I am delighted to share with you that I have been unanimously nominated as the Chairman of the Pharmacovigilance Standing Committee of the Indian Medical Association – Tamil Nadu State Branch (IMA TNSB) for the year 2019. While I did hold the position for 2018 in which year the committee was first established, my first term was well spent in creating awareness of pharmacovigilance among the state and national office-bearers of IMA, thanks to my legacy of having been a proponent of pharmacovigilance on several state and national platforms of IMA since 2010. I trust that my second term will help me go beyond the cream of the medical fraternity and induce the adoption of pharmacovigilance as an integral part of medical practice across all doctors in the state, with the co-operation of the highly experienced members of the committee. I hope IMA TNSB Pharmacovigilance Standing Committee would evolve into the firstof-its-kind platform for facilitating dialogue between prescribing physicians and drug safety physicians, which could, in turn, pave way for more productive pharmacovigilance mechanisms to be derived in the long run. As far as Oviya MedSafe is concerned, both ‘Physicians for Pharmacovigilance‘ and ‘Pharmacovigilance for Physicians‘ have been our goals since a long time. As a company, we at Oviya MedSafe are privileged to state that all our directors are seasoned medical professionals. Further, we have been vocal of our Expert Clinician Panel which was added as a specialty offering to Oviya MedSafe’s portfolio of services as early as in June 2014. Oviya MedSafe has played key roles in the conduct of quite a few customized pharmacovigilance awareness programmes for prescribing physicians, apart from supporting some advocacy initiatives organized under the aegis of IMA. Above all, the formal launch of Oviya MedSafe held at Coimbatore on 23-Feb-2013 had the then Honorary President and the Honorary Secretary of IMA TNSB as dignitaries among others, as a token of the medical fraternity’s compliments for the promising organization we were even at a time when we were just sprouting. In reciprocation, we at Oviya MedSafe take pride in re-dedicating ourselves to continue empowering physicians with our pharmacovigilance expertise, as our solemn commitment to the medical fraternity, beyond our business interests in pharmacovigilance. Having articulated these points in favour of my argument for uniting physicians for pharmacovigilance, I believe reading this note was worth your time and I am eager to hear your feedback on my views, if possible, in person. It will be my pleasure to catch up with you at Mumbai (India) on the 5th and 6th of April 2019 at the DIA India 7th Pharmacovigilance Conference which has given me the special honour of being the Session Chair for the first session of the first day (following the keynote address), thanks to my consecutive involvement as a Member of the Program Committee for this annual conference since 2016. I will again be in Mumbai on 26th July 2019 as the Chair of the Indian Pharmacovigilance Day 2019 conference (the 4th in the annual series under my Chairmanship), the agenda of which is still under development. 152 of 328


Please keep watching the conference website for information on the venue, topics and the speakers. Before concluding this bulletin, I am pleased to announce that I will be an Invited Speaker at the International Pharmacovigilance Day 2019 conference that is to be held in Barcelona (Spain) on the 12th and 13th of June 2019. I believe this will be an opportunity not only for me to meet my friends in Europe but also for our Oviya MedSafe team to formally connect with prospective business collaborators in the region. We will be delighted to accept meeting invitations from potential clients not only in Spain but in other European countries as well and include their locations too in our itinerary. Please do contact us if you are interested to hear about our global pharmacovigilance offerings which have been successfully availed by more than 50 delighted clients of ours since Oviya MedSafe’s inception in 2012. Looking forward to connecting with you shortly through our February 2019 newsletter, Oviya MedSafe – Patronizing the Pharmacovigilance Pachyderm February 2019 Dear Well-wishers, While I have heard all my life that absence makes the (fond) heart grow fonder, I experienced it in letter and spirit since the past few weeks when many of you eagerly enquired me about this February 2019 edition of Oviya MedSafe‘s newsletter which has been overdue for quite some time. In this materialistic world where distance and time, especially in combination, have been successful in disconnecting people, I am touched to see the unique bonding Oviya MedSafe has been able to establish with you over the years which justifies the salutation (‘well-wishers’) that I have used in every letter I have written to you so far. We all know that the term ‘pharmacovigilance’ means different things to different people. For non-industry stakeholders, it may, more often than not, denote the national pharmacovigilance programme of their country or region which is primarily meant for collecting adverse events reported by healthcare professionals and/or consumers. For members of the pharmaceutical industry, it may probably imply the pharmacovigilance requirements mandated of them by the regulatory/competent authorities in their country or region. For a vast majority of the pharmacovigilance workforce across the globe, it may almost exclusively mean the career opportunities it provides them either in pharmaceutical companies, pharmacovigilance service providing organizations, governmental agencies and international nodal bodies, among others. Last but not the least; the word means a thriving business vertical to pharmacovigilance entrepreneurs and corporate investors.

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I have always likened this lack of concatenation to the old Indian parable ‘Six Blind Men and the Elephant‘ used by the 19th century Hindu Saint Sri Ramakrishna Paramahamsa to describe the illeffects of dogmatism, which was made popular in the West by the 19th-century poet John Godfrey Saxe. With due respect and sensitivity to fellow pharmacovigilance professionals (as well as the visually impaired who have been referred to in this context only for the purpose of analogy), I envision that a lot more can be achieved in pharmacovigilance if the elephant is beheld in its full form by all this stakeholders concerned. Whenever I have been on a relevant platform, I have highlighted this point and such an opportunity came up recently, thanks to a special invitation I received from the Tamil Nadu Pharmaceutical Sciences Welfare Trust (TNPSWT). I was privileged to serve as an honorary trainer for the Pharmacovigilance Training Programme that was conducted in February 2019 at Chennai, by the ‘Pharma Knowledge and Training Institute’, a finishing school functioning under the aegis of the TNPSWT. The hall was full with enthusiastic PharmD (Doctor of Pharmacy) students who were eager and hopeful to pursue a career in pharmacovigilance and I felt a deep sense of fulfilment by sharing my perspectives on pharmacovigilance with them. I believe I was successful in showing the full form of the elephant to them within the couple of hours I had. On further extrapolation of this comparison, it may be appropriate to consider just the industry pharmacovigilance aspect as a smaller elephant by itself (especially in the outsourced pharmacovigilance services environment), as many pharmacovigilance professionals working in the industry have remained confined to their designated sub-verticals without exposure to the activities performed by their colleagues in other sub-verticals. At this juncture, I sense it is important for me to share with you a little more about how Oviya MedSafe has not only adopted but has rather patronized the holistic growth of this “Pharmacovigilance Pachyderm” over the past 7 years. In fact, I would say that the promotion of a ‘comprehensive portfolio of consulting and outsourced services in pharmacovigilance‘ was one of the key reasons behind Oviya MedSafe’s creation in 2012. Although it meant we were going against the conventions the industry considered to be sacrosanct, we dared to do it because we foresaw that it would be prohibitively difficult for small and medium-sized pharmaceutical companies to afford the services of the highly compartmentalized large-scale pharmacovigilance service providers who would be unable to bring down their astronomical charges thanks to the red-tapism involved. If you are keen to know more about Oviya MedSafe’s journey in this context, I invite you to go through the August 2016 (Oviya MedSafe in Outsourced Pharmacovigilance – Comprehensivising the Compartmentalised) and the January 2018 (Oviya MedSafe in Pharmacovigilance – Benefiting from an Unconventional Approach) editions of Oviya MedSafe’s newsletter. To sum up, Oviya MedSafe has emerged triumphant in leveraging the benefits of patronizing the pharmacovigilance pachyderm and is well-positioned to endorse that owning an elephant is always one’s strength. We have been able to prove this hypothesis ‘n‘ number of times by being able to facilitate quick deployment of a dependable end-to-end pharmacovigilance system for our clients at significantly short notices, for several markets including but not limited to North America, Europe, Middle East and India. With this proven track record, we are eager to extend our services to more and more clients throughout the world, with your positive references. 154 of 328


Before concluding, I would like to share with you an excellent article titled ‘How New Regulations Are Changing Product Approvals in India‘ authored by Dr Ramesh Jagannathan, which I had the pleasure of editing for publication as the India regional report for the March 2019 edition of DIA’s Global Forum magazine. On the events front, I am proud to state that I will be representing India at the International Pharmacovigilance Day 2019 (Pharmacovigilance within and without borders) conference which will be held at Barcelona (Spain) on the 12th & 13th of June 2019. I shall be speaking on the title ‘Pharmacovigilance in India – A Success Story‘ in the Global Pharmacovigilance Session and also participate in the ensuing panel discussion that will have my counterparts from Latin America, North West Africa and Pakistan too. In parallel, I am in the process of preparing the agenda for the much awaited 4th annual edition of the Indian Pharmacovigilance Day conference which is to be held under my Chairmanship at Mumbai (India) on 26th July 2019. Please keep visiting the conference website for further announcements in the forthcoming weeks. Assuring that our March 2019 newsletter will reach your inboxes at the earliest,

Oviya MedSafe – Defining Dignity in Pharmacovigilance March 2019 Dear Well-wishers, With utmost delight, I proudly share with you this March 2019 edition of Oviya MedSafe‟s newsletter (the 84th consecutive monthly issue) that commemorates the 7th anniversary of Oviya MedSafe’s founding! In our March months‟ editions of the past, I had focused either on narrating the anniversary celebrations or on introspecting about Oviya MedSafe‟s purpose of existence. In this year‟s anniversary issue, I wanted to reveal at a high level how Oviya MedSafe has metamorphosed to what she is today. My spontaneous attempt ended up in the following passage: “A tender bud that she was when she began her Life on 14-Mar-2012, she has gradually grown into a magnificent tree thanks to she having been watered with loads of optimism and learning; and by, many a time, swimming like a little fish amidst all odds, against the tide in an unchartered ocean. She came to prove that she is indeed a strong child that would not take no for an answer and went on to gain acceptance among her neighbourhood with nothing but her undying passion for her Life as her mission, which in turn has always been focusing on enlightening the houses of her wellwishers! Her flourishing beauty is not made up of her legacy but of the strength of her hard work and the power of her unassuming nature. She is a lighthouse for her fellow ships, the onlookers say, as I subtly smile with pride. 155 of 328


YES: Today, she is one of the world’s cherished brands in Pharmacovigilance, as experts applaud, much to the admiration of her kith and kin, who love her for what she is! Happy Birthday, Oviya MedSafe! Wishing you many more happy returns of the day!” While Prose demanded so many words to pass this message to the reader, Poetry was kinder to me by instantly invoking a quatrain that identified „resilience‟ as the most important strength that has been facilitating Oviya MedSafe‟s growth over the past 7 years, as follows: “The more the resilience, the longer the sustenance. The longer the sustenance, the higher the reliability. The higher the reliability, the better the patronage. The better the patronage, the surer the success.” At this glorious moment, I would be ungrateful if I do not recognize the contribution of my wonderful team members and the support of the trustful clientele of Oviya MedSafe distributed across the globe in establishing Oviya MedSafe as a trustworthy organization. The fact that this dignity was not offered on a platter but earned with sweat and tears is what makes Oviya MedSafe special. I firmly believe that the good thoughts of our well-wishers have played and continue to play a key role in keeping Oviya MedSafe in the fortunate position of being able to endure and grow through the challenges she has encountered with her undying passion for Pharmacovigilance. Apart from the anniversary, the month of March kept me busy with two important events, with the first being the 7th Pharmacovigilance Conference of DIA (Drug Information Association) India held at Mumbai in which I was a Program Committee Member and chaired a session that had presentations on global regulatory developments in Pharmacovigilance including ICH E2B (R3), FAERS, EudraVigilance and the impact of Brexit. The other event organised by the Indian Pharmaceutical Association (IPA) at Chennai was a Regulatory Session and had me speaking on „Pharmacovigilance in the Indian Pharma Industry„. Both these events provided distinctly different teaching-learning experiences. In terms of forthcoming events, I would like to inform you that the registrations for the Indian Pharmacovigilance Day 2019 conference that I am to Chair on Friday, 26th July 2019 at Hotel Kohinoor Continental, Mumbai are now open and that the organizers have announced Early Bird Discounts for a few weeks from now. Please click on https://www.townscript.com/e/indianpharmacovigilance-day-2019 to register online. As the agenda with the speakers is expected to be in place by next week, please keep visiting the conference website for updates. Before signing off, I take the liberty of requesting our Europe-based well-wishers to kindly let me know if you are interested in meeting up at Barcelona (Spain) when I come to speak on the topic „Pharmacovigilance in India – A Success Story„ at the International Pharmacovigilance Day 2019 conference scheduled for the 12th and 13th of June 2019. Looking forward to quickly re-connect with our April 2019 newsletter, 156 of 328


Oviya MedSafe – Regulatory Pursuit Beyond Pharmacovigilance April 2019 Dear Well-wishers, I am heartened much more than usual to reach out to you through this April 2019 edition of Oviya MedSafe’s newsletter, thanks to many of your kind words of compliments on the occasion of the 7th Anniversary of Oviya MedSafe’s founding that was featured in our March 2019 newsletter. Entering into our eighth year of existence is indeed an exciting moment for all of us at Oviya MedSafe. While we were busy the whole of March rightfully appreciating ourselves for our genuine achievements, I have started thinking since the beginning of April about the road ahead for Oviya MedSafe. Given the ever-changing global pharmacovigilance scenario, Oviya MedSafe has, without any doubt, been quite successful in conceptualizing, packaging and delivering customized consultancy and outsourced services in pharmacovigilance to all kinds of clientele. With this stronghold in place, I believe the time has come for Oviya MedSafe to spread our wings beyond pharmacovigilance, for propelling us into the next phase of growth. As the first step, Oviya MedSafe is considering setting up a Regulatory Consulting Services portfolio in a phased manner. Regulatory Affairs is often seen as the closest cousin of Pharmacovigilance in the industry and truly so. I would further say that these cousins depend on each other as much as they are answerable to each other. Incidentally, regulatory consulting came out as the first option when I brainstormed with my team members on what Oviya MedSafe’s first venture beyond pharmacovigilance should be. Accordingly, we have started the groundwork in this direction. The regulatory services vertical shall either be developed organically or by acquiring a regulatory consulting firm, based on whichever would work for us. Meanwhile, I solicit your kind consideration of Oviya MedSafe for your regulatory service needs in addition to your pharmacovigilance requirements. I am confident that Oviya MedSafe’s regulatory offerings will be well-received and encourage us to add many more of such allied areas of business. Speaking of regulatory, I am reminded of the agenda of the Indian Pharmacovigilance Day 2019 conference that is to be held under my chairmanship at Hotel Kohinoor Continental, Andheri East, Mumbai on Friday 26th July 2019, as it has coincidentally come out as an assortment of topics that deal with the relationship between Regulatory Affairs and Pharmacovigilance. Apart from this aspect, the conference has sessions dedicated to Indian compliance, technology in pharmacovigilance and other special scenarios. I am grateful to Dr Sanish Davis and Dr R K Sanghavi who readily accepted my invitations to speak at the conference on the topics I handpicked for them. Most of the other topics too have been mapped to suitable speakers who are in the process of procuring the requisite internal approvals from their respective organizations to confirm their participations. Please keep watching the conference website for updates. As you 157 of 328


may be aware, the registrations for the conference have already started and the places are filling fast. To register yourself for the Indian Pharmacovigilance Day 2019 conference, click on https://www.townscript.com/e/indian-pharmacovigilance-day-2019 and follow the instructions on the portal. I am happy to inform you that Life Science Academy (a business unit of Italy-based EasyB srl, represented in India by their partner agency VHEO Ventures), the organizer of the conference, has announced extension of the Early Bird Registration deadline to 30th June 2019. They have also enabled group discounts for all categories of delegates, special rates for nonindustry professionals, and discounted rates for students in order to facilitate representation of all stakeholders of pharmacovigilance in India at the conference. Before concluding, I wish to once again thank you for your goodwill for Oviya MedSafe ever since we started our journey in 2012. Waiting to meet you through our May 2019 newsletter,

Oviya MedSafe – Balancing Subject Matter Expertise & Technology in Pharmacovigilance

May 2019 Dear Well Wishers, I am pleased to reach out to you through this May 2019 edition of Oviya MedSafe‘s newsletter which intends to elucidate Oviya MedSafe’s pragmatic approach in balancing subject matter expertise & technology in pharmacovigilance, a strategy that has kept us lean and therefore successful ever since we adopted it in 2012. Oviya MedSafe is well-qualified to deliberate on this topic as we have not only advised, sourced, customized and deployed appropriate technology to support the pharmacovigilance functional systems we created for ourselves as well as for our clients; but as we have also been contracted for providing functional consultancy services to organizations that work exclusively on the technical side of pharmacovigilance. While the first part of the preceding sentence was explained in our April 2017 newsletter, I would like to share my thoughts on the second part in a little more detailed manner in this edition. While technology has greatly accelerated the ability of any subject to be advanced further, pharmacovigilance is no exception. Starting from a simple spreadsheet to a modern full-fledged pharmacovigilance software database, technology has taken pharmacovigilance experts through an exciting journey which progressively reduced the time consumed by non-core tasks thereby saving it for activities involving higher functional analysis. Today, the buzzwords Robotic Process 158 of 328


Automation (RPA), Artificial Intelligence (AI), Cognitive Computing, etc, stand for the emergence of technology-aided pharmacovigilance of the highest order that the previous generation of pharmacovigilance experts could only feel envious about. While technology does resolve several logistical issues pertaining to pharmacovigilance, it is important to recognize that even the most revolutionary technological tool will require functional inputs at several levels, along with provisions for appropriate checks and balances. In other words, facilitating the building of futuristic yet dependable technological products for pharmacovigilance and ensuring that they are fit for purpose could well be specialized pharmacovigilance consulting activities by themselves. Oviya MedSafe takes pride in having realized this fact several years ago and developed holistic pharmacovigilance subject matter expertise which now proves to be a skill set that many pharmacovigilance technology companies yearn for, regardless of whether they work for large pharmaceutical companies or for their small & medium-sized counterparts. On taking a deeper dive into the topic, it is clear that technology does not stop with pharmacovigilance software databases alone. Mobile applications for reporting adverse events, applications which harvest potential drug safety data from social media, proprietary workflow applications designed by some organizations to standardize certain parts of their pharmacovigilance processes, intuitive off-the-shelf software applications meant for helping medical information staff with the right questions to be asked when callers report adverse events, tailored tools for reconciling safety data, portals for securely transmitting safety data between organizations, pharmacovigilance document management systems, and electronic training modules with performance metrics are some instances in which technology is closely involved in pharmacovigilance beyond safety databases. Obviously, all of these and many more of such offerings need ongoing functional advice in order for them to cope up with the ever-changing regulatory scenario. This is particularly difficult for technology companies which may have little or limited exposure to the functional side of pharmacovigilance. Thanks to our rich pharmacovigilance domain experience of working with a variety of pharmaceutical clients across the globe for the past seven years and our astute understanding of the challenges faced by pharmacovigilance toolmakers, Oviya MedSafe is now being increasingly recognized as a strategic partner by pharmacovigilance-focused technology companies that wish to develop cutting edge pharmacovigilance products. Although many would argue that regulation is the primary driver for so many pharmacovigilance activities to be performed in the industry, conscientious pharmacovigilance professionals would understand that such regulation exists in the first place in order to secure the interests of the consumer who takes a drug trusting that it would benefit them. While any drug cannot be expected to render only benefits to all consumers all the time, the proper performance of applicable pharmacovigilance activities would ensure that a consumer’s risk is reduced to as less as possible while leveraging the maximum therapeutic benefit for the consumer. I have been invited to elaborate on this concept at the ‘Continuing Medical Education on Pharmacovigilance: Clinical Implications‘ organized by Vydehi Institute of Medical Sciences & Research Centre, Bengaluru in collaboration with the Pharmacovigilance Programme of India (PvPI), on 19th July 2019 at the college. I am eager to deliver my address on the topic “The Role of Pharmaceutical 159 of 328


Industry in bringing about Translational Pharmacovigilance” and look forward to interact with the students and young professionals in Bengaluru. Last but not the least; I wish to speak a little about the annual Indian Pharmacovigilance Day conference which I will chair for the 4th consecutive time this year. The 2019 edition of the conference which is to be held at Hotel Kohinoor Continental, Mumbai on Friday, 26th July 2019 boasts of a galaxy of seasoned speakers who will deliberate upon matters of contemporary significance in the context of the various forms in which pharmacovigilance exists in India. I hear from the organizers that the agenda has already attracted a good number of delegate registrations and that they expect to reach a record number of participants before the last minute fee becomes applicable on the registration charges after 21st July 2019. To register yourselves to be part of this phenomenal knowledge-sharing gathering, please click on https://www.townscript.com/e/indian-pharmacovigilance-day-2019. Waiting to meet you through our June 2019 newsletter,

Oviya MedSafe – Proudly Representing Indian Pharmacovigilance Internationally June 2019 Dear Well-wishers, With a great deal of exuberance, I write this June 2019 edition of Oviya MedSafe‘s newsletter by which I wish to characterize the unprecedented nature of the pride that I experienced while participating as an invited speaker representing India at the first-of-its-kind International Pharmacovigilance Day conference that was held at Barcelona, Spain on 12th and 13th June 2019. The International Pharmacovigilance Day 2019 conference was organized by Life Science Academy (a business unit of Italy-based EasyB srl) with the apt theme ‘Pharmacovigilance within and without borders‘. It had learned speakers from several parts of the world deliberating upon contemporary topics in pharmacovigilance. Unlike the other conferences of the ‘Pharmacovigilance Day‘ series which usually focus on pharmacovigilance issues of interest to the particular country and/or region in question, the International Pharmacovigilance Day provided ample scope for the delegates to hear about the pharmacovigilance developments in many parts of the world, and not just the EU and the UK, in considerable detail. While not only me as an individual but Oviya MedSafe as an organization too were already wellaccustomed to discussing pharmacovigilance at many international conferences and training workshops in foreign locations, this was a little different assignment for us as our sole objective was to enlighten a non-Indian audience about all forms of Pharmacovigilance that exists in India. Thanks to the collaborative interactions I have had with the competent authorities for pharmacovigilance in India in my various honorary roles and with Oviya MedSafe’s track record of 160 of 328


delivering a wide range of global (as well as Indian) regulatory pharmacovigilance business projects from India, I was able to put together a comprehensive picture of India in the context of pharmacovigilance so much so that everyone involved in the activity asked for my speech to be titled “Pharmacovigilance in India – A Success Story“, which was also approved by the Session Chair Ms Jabeen Ahmed who was of extraordinary support to me in fine-tuning the contents of my talk. The session also had Mr Farrukh Malik and Ms Renata Yoshida Shihomatsu who spoke about pharmacovigilance in Pakistan and Latin America respectively, apart from Ms Jabeen Ahmed who shared insights about the regulatory pharmacovigilance scenario in China. At this juncture, I pause to ponder if I could stake exclusive claim for the applauses I received immediately after my speech, for the simple reason that most of the extensive relevant content I presented was the outcome of the hard work of many policy-makers in India, mainly the Pharmacovigilance Programme of India led by Dr G N Singh and Dr V Kalaiselvan, whose efforts went a long way in making the Ghaziabad-based Indian Pharmacopoeia Commission (IPC), the National Coordination Centre (NCC) of PvPI, a WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services in 2017. Of course, putting things in perspective may have been my strength but I must take this opportunity to thank my Oviya MedSafe colleagues Vidhya and Gayathri for preparing a succinct slide deck which helped me complete the coverage of this vast topic within 20 minutes. Before concluding, I wish to share another piece of good news: Oviya MedSafe is proud to be the host for the first ever face-to-face MedDRA training programme that will be conducted by MSSO in Chennai (India). The two-day classroom training programme will be held on 19th and 20th Sep 2019 at Ma Foi House in Anna Nagar, Chennai. For more details, please visit https://www.meddra.org/training/schedule/face-face-training-coding-meddra27 and https://www.meddra.org/training/schedule/face-face-training-meddra-safety-dataanalysis-and-smqs-24. Each MedDRA license-holding organization may nominate a maximum of 5 trainees for this free training programme. Hurry – only 20 seats have been opened up for this schedule at Chennai! Looking forward to meeting you through our July 2019 newsletter soon,

Oviya MedSafe – The Origin of Pharmacovigilance Celebrations in India July 2019 Dear Well-wishers, While we are in September 2019 observing the first ever World Patient Safety Day, I wish to dwell upon how we celebrated the Indian Pharmacovigilance Day this year, through this July 2019 edition of Oviya MedSafe‘s newsletter. Although I need to release one more edition (August 2019) 161 of 328


in order to claim that I have cleared my backlog of the due monthly newsletters, I take refuge in the excuse that this delay has only made the July edition more relevant now than in the past! Unlike the World Patient Safety Day, the Pharmacovigilance Day was not proclaimed by the WHO but instead conceived in 2014 by Life Science Academy (a business unit of Italy-based EasyB srl) as a series of country/region-specific pharmacovigilance conferences organized throughout Europe. During my first association with Life Science Academy as Chair of their first UK Pharmacovigilance Day at London in 2015, I made a proposal to them for the conference to be customized for and introduced in India. It was at that point of time that I identified the last Friday of July as a suitable day for conducting the first such conference in India. Little did I know then that the random date I chose would get entrenched in history as a Festive Friday meant for celebrating pharmacovigilance in India every year. That the awareness of this observance has gone up to an unprecedented level throughout the country was evidenced from the fact that I ended up playing pivotal roles in three distinct meetings held in three different cities on the occasion and respectfully denying a few more events due to my crowded calendar in July 2019, albeit being successful in my race against time to author an invited article. More than the joy of being the pioneer, the fact that my action indeed resulted in an annual season in which all relevant stakeholders enthusiastically promote pharmacovigilance awareness in India is what heartens the pharmacovigilance aficionado in me. This year’s celebrations began for me with a guest lecture I delivered on the topic ‘An overview of Pharmacovigilance and its relevance to Life Science Professionals‘ on 03-July-2019, to Biotechnology students of KSG College of Arts and Science, Coimbatore. I must say that the students of this institution were unique in the sense that they were intensely inquisitive knowledge-seekers and I truly enjoyed answering their thoughtful questions. Please click here for some pictures of the vibrant Q & A session. The next activity was the publishing of my invited article titled ‘Gap analysis of some key stakeholders of Indian pharmacovigilance‘ in the 16-31 July 2019 edition of Express Pharma, a leading pharma industry news magazine from India. As I mentioned before, I worked on this article only when I found time amidst the commitments of the celebratory month but I was delighted to receive positive feedback from the concerned stakeholders themselves. Please visit this link to read the article. As always, comments are welcome. Thirdly, I honoured and was honoured by an invitation to speak on the topic ‘The Role of Pharmaceutical Industry in bringing about Translational Pharmacovigilance‘ at a Continuing Medical Education (CME) programme on pharmacovigilance and its clinical implications organized in Bengaluru by and at the city-based Vydehi Institute of Medical Sciences & Research Centre (VIMS & RC) in collaboration with the Pharmacovigilance Programme of India (PvPI) on 19-July2019. While I shared my perspectives on how the various regulatory-driven pharmacovigilance activities performed by the industry could result in tangible Patient Safety benefits, I also learnt a lot from the other speakers who were specialists in their own expertise areas. I have no hesitation in stating that I am yet to come across a clinician in any other institution who has a better 162 of 328


understanding of pharmacovigilance than the medical practitioners I met at VIMS & RC. To view/download some pictures clicked at the gathering and the detailed agenda of the day, please go to this page. Coming to the best at the last, namely, the fourth annual edition of the Indian Pharmacovigilance Day conference that I chaired at Mumbai on 26-July-2019! In the line of its predecessors, the Indian Pharmacovigilance Day 2019 conference too was quite successful. I thankfully acknowledge Mr Enrico Pedroni, Managing Director of EasyB srl, who took the time to welcome everyone to the event with this video address. In terms of choices for the contents and the speakers, I had consciously ensured a mix of “traditional & futuristic” and “seasoned & promising” respectively, which contributed to the high impact factor of the deliberations as I learnt from the delegates later. While I would love to narrate each session of the day in detail, I prefer to re-direct you to the vivid post-conference coverage given by Express Pharma, as I am sure they have not missed anything significant. Some pictures from the conference are available on my LinkedIn post. The full set of official photographs may be accessed from this Google Photos URL. Oviya MedSafe was one of the sponsors for the conference. At this juncture, I express my sincere thanks to all the speakers, delegates, sponsors, organizers and their representatives, among other contributors, for the unflinching support they extended to me in conducting yet another successful Indian Pharmacovigilance Day conference with the pharmacovigilance fraternity in India already keen to register for the 2020 edition. Eagerly waiting to meet you soon through our August 2019 newsletter,

Oviya MedSafe – Refining Managed Services in Pharmacovigilance August 2019 Dear Well-wishers, I am delighted to present this August 2019 edition of Oviya MedSafe‘s newsletter, with the satisfaction of having cleared my backlog of the due monthly missives. In this issue, I wish to highlight a conscious approach by which Oviya MedSafe, on behalf of our clients, has been ensuring the timely performance of their critical pharmacovigilance compliance activities (of comparatively lower volumes per client for numerous clients) in a cost-effective yet qualityuncompromised manner while maintaining sufficient professional supervision which is something each of our clients found to be a unique feature of Oviya MedSafe. Right from our inception in 2012, Oviya MedSafe has not only taken up routinely outsourced pharmacovigilance assignments but has also strived to fulfil the gap in the industry, namely the provision of customized comprehensive support for a specific range of pharmacovigilance requirements limited by regional regulatory norms, narrow product portfolios or companydefined business needs. This has been possible because Oviya MedSafe was conceived not just as 163 of 328


yet another pharmacovigilance service-provider but as a specialized organization that renders consulting as well as outsourced support in global and local pharmacovigilance, with a particular focus on small and medium-sized pharmaceutical companies. Oviya MedSafe was early to recognize that the majority of the pharmaceutical clients (especially in India and other emerging markets) did not need segmented large teams trained in only one area of pharmacovigilance but rather would benefit from small teams of “pharmacovigilantes” who had a holistic understanding of pharmacovigilance. Hence, our training modules were designed accordingly and we have been successful in building several of such “pharmacovigilantes” over the past 7 years. Naturally, this meant that our team members were always able to be one step ahead of our counterparts in other organizations, thanks to our concentration on “horizontal” rather than “vertical” excellence. With time, this has resulted in the development of Oviya MedSafe’s time-tested business model of administering Managed Services in pharmacovigilance. By this model, Oviya MedSafe engages with a typical client at the stage of planning the pharmacovigilance activities they are required to perform and works out a clear matrix in which the exact roles of Oviya MedSafe in the engagement are described. In scenarios where a consultative element is involved or an end-to-end outsourcing activity is involved, appropriate project management plans are made and finalized beforehand with the client. However, if the requirement is for an extended team of the client’s that would work with them in a like-minded manner with an excellent understanding of their product portfolio and applicable pharmacovigilance compliance obligations, Oviya MedSafe’s “pharmacovigilantes” would be readily assigned under this Managed Services formula with just enough paperwork to serve as driving documents for the project in question. Led and guided by a Drug Safety Manager, such a vibrant team of “pharmacovigilantes” would have experienced pharmacovigilance professionals deputed in Full Time Equivalent (FTE)-based contracts for that particular client/project. Such FTEs could be either exclusive to the client or shared with other clients based on the volume of work but, in any case, they would be fully governed by Oviya MedSafe’s written procedures and organizational policies. Moreover, Oviya MedSafe’s Medical Safety department will provide its insights wherever required and the whole set of activities will have adequate surveillance by Oviya MedSafe’s Quality Assurance department. While other organizations may also provide such support in a Staff Augmentation model where the onus of getting the work done from the team rests with the client, Oviya MedSafe goes one step further by taking ownership of the productivity and quality of the team’s deliverables by putting thorough internal checks and balances in place. For more information on our Managed Services in pharmacovigilance, please contact us. Before signing off, let me take the pleasure of sharing with you an interesting article that I had the privilege of editing for the August 2019 edition of DIA’s Global Forum, for which I serve as the India Regional Editor. The regional report for the month was written by Dr Srikanth Krishnamurthy; a leading Pulmonologist & Clinical Trial Investigator based in the city of Coimbatore in India and is titled “Transition from Physician to Clinical Trial Investigator in India: Today’s Research is Tomorrow’s Practice“. True to its title, this report traces the journey of a typical clinician in India through the discipline of Clinical Research. This widely acclaimed article 164 of 328


evolved into a niche professional milestone of mine about which I would like to speak in detail, along with a few more interesting updates, in the September 2019 edition of Oviya MedSafe’s newsletter that is to be released shortly. Thanking you for your continuous patronage and eager to re-connect soon,

Oviya MedSafe as India’s Pharmacovigilance Ambassador to America September 2019 Dear Well-wishers, After a while, I am back to connect with you thanks to this September 2019 edition of Oviya MedSafe‘s newsletter which aims to narrate unforgettable anecdotes from the month and also reveal the rationale behind the title of this bulletin. On 3rd September 2019, I participated as the Keynote Speaker in the one-day national level seminar “Current Scenario of Patient Safety Vigilance Activities in India” organized by KMCH College of Pharmacy based in Coimbatore, India. At the event, I addressed more than 300 young pharmacists on the topic “Pharmacovigilance in India – A 360 Degree View“. While I have been the prime dignitary in many a function over the past several years, the inaugural session of this seminar was the first occasion on which I got to share the dais with and also be privileged to be honoured by the Chairman of the KMCH Group of Institutions Dr Nalla G Palaniswami who has been my Role Model for a Medical Entrepreneur (of the highest order) since my medical college days. To view some pictures from the day, please click here. In the later half of the month, Oviya MedSafe earned one more “first” to its credit by hosting the maiden face-to-face MedDRA training programme conducted by the MSSO at Chennai (one of India’s metropolitan cities).The classroom sessions for the topics ‘Coding with MedDRA‘ and ‘Safety Data Analysis and SMQs‘ were held on 19th and 20th September 2019 respectively at Ma Foi House, Anna Nagar. All the 30 seats opened up for this schedule were booked by various MedDRA license-holding organizations (including Oviya MedSafe), thereby making this educational initiative greatly successful. Oviya MedSafe wishes to sincerely thank the trainer Dr Anamika Dutta, MSSO team, Ma Foi Strategic Consultants Pvt Ltd (a shareholder of Oviya MedSafe) who provided the venue & administrative support staff for the training programme and last but not the least, the vibrant batch of trainees without whom we could not have achieved this milestone. As a conscientious fosterer of pharmacovigilance subject matter expertise for the forthcoming generations, Oviya MedSafe takes great pride in having been the pioneer in bringing MSSO to Chennai for this capacity-building activity. Another special recognition bestowed on me during the month was an opportunity to take part in an audio interview titled “New Ethics and Consent Guidelines: Pillars for Safety in India” for 165 of 328


the Drug Information Association (DIA). The interaction, which had Dr Alberto Grignolo (Editor-inChief of Global Forum, a DIA publication) as the interviewer and Dr Srikanth Krishnamurthy (a leading Pulmonologist & Clinical Researcher based in Coimbatore, India) as my co-interviewee, was published as a 27-minute podcast on DIA’s official podcast channel. While Dr Srikanth discussed the pre-market clinical research safety perspective, I contributed the perspective of post-market drug safety in India. Please listen to the podcast and kindly share your feedback with me. At this juncture, I wish to thank Dr Grignolo and the entire DIA Publications team for inviting me to join. While on the topic of DIA, I believe it will be pertinent to make the announcement about which I hinted earlier: I have been invited to deliver a speech titled “Post-Approval Pharmacovigilance Obligations for the Industry in India: Current Scenario” at the Pharmacovigilance and Risk Management Strategies Conference that is to be organized by the DIA from 27th to 29th January 2020 at Washington, DC. Both as an individual and as the CEO of a pharmacovigilance-interested organization who attended the same conference in 2015 as a sponsor, I am heartened at Oviya MedSafe’s organizational growth as well as our sustained contribution to the betterment of the Indian pharmacovigilance milieu that have resulted in this moment of esteem within a five-year period. On a related note, I have been thinking of using this visit to the USA for further strengthening Oviya MedSafe’s strategic collaborations in North America and I am more than keen to welcome meeting requests on these lines. Though my itinerary will focus on the East Coast, I would be happy to travel to other parts of the US if required. Please feel free to reach out to me directly for discussions in this regard. Eager to meet you through our October 2019 newsletter soon,

Oviya MedSafe – Walking with DIA on the Pharmacovigilance road October 2019 Dear Well-wishers, While I take the pleasure of penning this October 2019 edition of Oviya MedSafe‘s newsletter, I thankfully acknowledge those of you who took the time to listen to my 27-minute audio interview to the Drug Information Association (DIA) that was highlighted last month. I sincerely appreciate the positive feedback you personally shared with me and am enthused to update you that the DIA further honoured me by featuring me on the cover page of the month’s issue of Global Forum (a DIA publication), with my podcast being embedded in it. I had always wanted to write an account on the crucial role of DIA in my professional journey and I believe this could be a right time to reminisce upon my evergreen memories of how DIA enabled 166 of 328


the realization of my larger dreams for pharmacovigilance. Interestingly, I had recorded my feelings for DIA as a requested testimonial as early as in 2016, as follows: “As a pharmacovigilance professional, DIA was the first forum that gave me the access to listen to speakers from a variety of organizations and comprehend the interdisciplinary nature of the subject. Much of my fascination with pharmacovigilance could be attributed to the insights I received by participating in DIA Pharmacovigilance Meetings, which indeed played a causal role in me becoming a pharmacovigilance entrepreneur. It has been my pleasure to have been associated with DIA events as a delegate, sponsor and most recently as a Program Committee Member and Moderator of a Panel Discussion session in the DIA India Pharmacovigilance Conference 2016. I am sure I am not exaggerating when I say that DIA has always been and will ever continue to be close to my heart, as an active facilitator of my career growth and my first window to get exposed to the realm of pharmacovigilance. Thank you from the bottom of my heart, DIA!“ However, I had not sensed then that it was just the beginning and DIA rather had much more in store for me. Not only did I continue contributing as a Speaker, Session Chair and Program Committee Member to the subsequent DIA India Pharmacovigilance Conferences every year, I was also invited to write an article for Global Forum which later earned me the honorary position of Regional Editor (India) of the DIA publication. Thanks to DIA, I have had enjoyable experiences of collaborating with several doyens in the Healthcare, Pharmaceutical and Life Sciences domains, by getting them onboard as guest authors on different occasions. The latest distinction that DIA conferred on me is undoubtedly the invitation to represent India in Washington DC at the 2020 edition of the world’s biggest pharmacovigilance conference, namely the Pharmacovigilance and Risk Management Strategies Conference held in the United States of America in January every year. I am eager to present my views on the topic “PostApproval Pharmacovigilance Obligations for the Industry in India: Current Scenario” which will be part of a session chaired by Dr E Stewart Geary (Senior VP, Chief Medical Officer & Director, Corporate Medical Affairs HQ at Eisai). With my co-speakers Rie Matsui and Stella Xu representing Japan and China respectively, this session will ensure that key pharmacovigilance updates from the Asia Region, especially those of regulatory relevance to the pharmaceutical industry, be shared on a global platform. I hope I would be able to meet many of you at the conference and engage in productive discussions on the subject. I trust this event could also serve as a forum for us to explore scopes for professional synergies. I am keen to entertain meeting requests in Washington DC during the conference period and in other parts of the USA during the following week. If you are interested in having a dialogue with Oviya MedSafe, I request you to reach out to us as early as possible so that we can freeze the slots on our calendars. Looking forward to connect through our November 2019 newsletter, 167 of 328


Oviya MedSafe – Making Pharmacovigilance Lean Since 2012 November 2019 Dear Well-wishers, As we near the end of yet another happening year, I warmly express my hearty wishes to you and yours, for the forthcoming New Year, through this November 2019 edition of Oviya MedSafe‘s newsletter! I have always believed, albeit in a metaphorical sense, that every end is in some way a precursor of another new beginning. Extrapolating it literally, I am abundantly hopeful that 2020 has loads of good tidings for all of us. As an organization, Oviya MedSafe ventured into the pharmacovigilance domain at a time when end-to-end pharmacovigilance services were unaffordably expensive for small and medium-sized operators in the pharmaceutical industry. Ever since its birth in 2012, Oviya MedSafe has been constantly striving to make pharmacovigilance a more economical exercise for such cost-conscious companies. It may be surprising that such a significant and rather vital issue like Patient Safety in the context of Drug Safety was getting so little importance in the pharmaceutical industry despite it carrying a regulatory mandate for them. But, Oviya MedSafe was able to understand their hesitation because most companies under this category were almost exclusively generic in nature and they saw no overt benefit in building up their pharmacovigilance departments in order to study the safety profiles of drugs that were not developed by them. It was clear that “a perceived lack of incentive” prevailed. Although one could rightly argue that pharmaceutical companies should be held accountable for adverse events occurring with the use of their medicinal products, this was the stark reality. It was in this context that I spoke in conferences and wrote in a past edition of our newsletter about the rationale I conceived about the potential business benefits a generic drugmaker could beget by performing pharmacovigilance properly, beyond achieving regulatory compliance. Express Pharma, a leading pharmaceutical industry magazine based in India, published this as an invited article titled ‘Pharmacovigilance as a value addition for the pharma industry‘ which I hear is one of the most widely read write-ups on this rare but essential topic. From a practical point of view, the cost of pharmacovigilance support lent to the industry comprises not only the professional charges for the activities performed on behalf of the client but also the license fees for all the technology products used (including but not limited to the pharmacovigilance software database). While Oviya MedSafe always treaded the path of being client-friendly in terms of pricing our services, we did have challenges in getting the legacy technology partners to lower their costs for generic companies in our early days. Fortunately, in due course, we identified technology partners who shared our wavelength and our partnerships with them permitted us to widen our client base thanks to the overall cost reduction that made Oviya MedSafe attractive. Moving further, we have continued signing up with more agile technology partners possessing cutting edge expertise so that we will be able to offer a variety 168 of 328


of integrated pharmacovigilance solutions for our clients to choose from, with no compromise in quality or compliance in any of them. This has been possible because we are functional consultants for technology companies focusing on the pharmacovigilance domain and therefore we fully understand the products available in the market as well as those in the pipeline. To summarize, we at Oviya MedSafe have left no stone unturned in our pursuit of excellence in pharmacovigilance. We believe that our broad-based knowledge in the domain has equipped us to shape our pharmacovigilance processes as lean as possible, which in turn have always been remarkably advantageous for our clients. Before signing off, I wish to share that I have been invited to speak at the DIA Pharmacovigilance & Risk Management Strategies Conference 2020 that is to be held at Washington DC from 27th to 29th January 2020 and I hope I will get an opportunity to catch up with some of you at the event. Keen to meet you soon through our December 2019 newsletter,

Oviya MedSafe – Passionately Perpetuating Pharmacovigilance Proficiency December 2019 Dear Well-wishers, I experience concurrent feelings of surprise and redemption as I pen this first note for you in 2020, since this bulletin is actually the December 2019 edition of Oviya MedSafe‘s newsletter that should have been released at least by my liberally self-set timeline of 31st January 2020. I am surprised when I recollect that 2020 has been so busy for me from Day One with the initiation of a bunch of Pharmacovigilance contracts recently awarded to Oviya MedSafe that I had to procrastinate this favourite ‘pleasant duty‘ of mine until the end of February. While this is indeed a good problem to have, what makes me feel redeemed is that I have now been able to resume writing to you after ensuring the successful set-up of all these projects to the delight of our new clients, even amidst my pre-planned USA tour, thanks to my seasoned yet vivacious managerial team. Over the past 8 years, I have stated many a time that Oviya MedSafe’s journey in Pharmacovigilance has always been driven by Passion. In fact, it was my Passion for Pharmacovigilance that resulted in me getting absorbed into it even when I had an already wellestablished clinical practice for a career, so much so that I once mentioned that “Pharmacovigilance chose me” rather than the other way round. At this juncture, it may be relevant for me to quote a definition of Passion that I coined for myself in 2013: “Passion is defined as the natural desire that reigns so strongly from one’s heart that it refuses to surrender to any external pressure even amidst adversity“. Speaking figuratively as well as literally, could any other field contain so much of “adversity” in itself as Pharmacovigilance does? And, having 169 of 328


practised Pharmacovigilance with such Passion since 2012, it is no surprise that Oviya MedSafe has grown to be known as a crusader for pharmacovigilance, empowered by adversities all along! Does Passion have all the answers? Of course, not. But, Passion searches for them without giving up. As we all have heard, “where there is a will, there is a way“. In Pharmacovigilance, our relentless quest for knowledge habituated us to continuous learning, which in turn evolved into a broad range of capabilities. As we kept offering these capabilities to our clients as services, we not only developed a track record but also consciously upskilled ourselves to match our competence with the business needs of our clients, thereby setting a strong foundation for building our people and processes further. Obviously, we could not have achieved all that we have today if we had compromised on ethics. Our firm insistence on integrity ensured that our environment imbibed it and then we became an organization that proudly follows its core values to a T. In a holistic sense, this is what I see as Proficiency and I am heartened to observe that Oviya MedSafe has developed the innate capacity to radiate it in Perpetuity. At this time when we are adding many new clients to our portfolio and are looking forward to increase our headcount, I feel it is essential for us to reflect upon our own history and motivate ourselves to face the next part of our fascinating journey which is definitely going to be much larger in terms of scale and much wider in the context of global reach. While we understand that what brought us here may not always get us there, we also trust that what brought us here should never be undermined in pursuit of something that could possibly get us there! Hoping that I have not treated you with an unintentional overdose of philosophy, let me take the pleasure of introducing an article on a non-Pharmacovigilance topic before I conclude this letter. As the India Regional Editor of Global Forum (a Drug Information Association publication), I am glad to present the regional report “Should Patient Involvement and Engagement Have Minimal and Maximal Limits? A Perspective From India” written by Dr J Mariano Anto Bruno Mascarenhas for the January 2020 edition. Please click on the URL https://globalforum.diaglobal.org/issue/january-2020/should-patient-involvement-andengagement-have-minimal-and-maximal-limits-a-perspective-from-india/ to access the opinion piece. Eagerly waiting to connect with you through our January 2020 newsletter,

Oviya MedSafe in Pharmacovigilance – Soaring above the COVID-19 cloud January-July 2020 Dear Well-wishers, Today, I am brimming with enthusiasm at the thought of being able to write to you after quite a long time. In fact this January-July 2020 edition of Oviya MedSafe‘s newsletter (the 94th in the 170 of 328


series) is the very first one to be published in a non-monthly frequency ever since Oviya MedSafe was founded in 2012. While continuous inflows of new projects since the beginning of this year and the efforts we had to invest in order to move to a complete Work From Home (WFH) model due to the COVID-19 pandemic kept me away from my cherished routine, I am delighted to place on record that Oviya MedSafe has risen up to the global challenge and has been extremely successful in ensuring 100% business continuity for all of our clients, thanks to our diligent and proactive team members whom I am always proud of. The year 2020 started with yet another recognition for Oviya MedSafe on a global stage, when I was invited to be part of a very well-received session on Asia Region Updates that was chaired by Dr E Stewart Geary, on Day 1 (27th January) of the Drug Information Association‘s (DIA) Pharmacovigilance & Risk Management Strategies Conference 2020 at Washington DC. I spoke on pharmacovigilance obligations for the industry in India, while Rie Matsui and Stella Xu spoke about the recent developments in Japan and China respectively. Apart from giving me this wonderful opportunity to present India’s phenomenal achievements at this prestigious gathering of pharmacovigilance professionals from several parts of the world, DIA extended the privilege further by publishing the summary of the entire session in the March 2020 edition of Global Forum. All through the busy months of January & February, I never thought the 8th Anniversary of Oviya MedSafe’s founding, which was due to be celebrated on a grand scale in March, would instead go virtual and turn out to be a simple observance close to our hearts. But, what could better signify the festivities of pharmacovigilance than adversity? And, isn’t having no time to celebrate an anniversary because of a slew of long-term end-to-end global Drug Safety and Medical Information contracts being awarded in quick succession, a reason for celebration by itself? So, that was how and why we silently rejoiced at Oviya MedSafe’s triumphs, while preparing ourselves for the New Normal of WFH. Thanks to our forethought that navigating this pandemic could be a long haul and further to the excellent co-operation provided by each member of the Oviya MedSafe family, we have swiftly and completely adapted to the sudden paradigm shift that COVID-19 enforced upon all of us. Thankfully, I was also able to do my bit in raising awareness about COVID-19. The interesting combination of my medical qualification and my entrepreneurial experience was instrumental in me being identified as an ideal candidate for moderating an awareness webinar on the COVID-19 situation, conducted jointly by the Kerala Chapter and the Coimbatore Chapter of The IndUS Entrepreneurs (TiE) on 16-Apr-2020. The online event which was primarily meant for owners of Micro, Small & Medium-sized Enterprises (MSMEs), had Dr Sudha Ramalingam as the Subject Matter Expert. The recorded version of the hour-long webinar is available on YouTube and I believe watching it will be worth your time, as it provides authentic yet practical tips on all that you need to know about COVID-19. Although the audience was comprised of MSME entrepreneurs, the proceedings of the session could be useful for anyone outside the healthcare fraternity. Please feel free to share this link with your near and dear. 171 of 328


As we traversed the month of May, I involved myself in two activities linked to the International Clinical Trials Day 2020. The first was an unplanned article that I wrote within an hour of an idea flashing in my mind while I was wondering how everyone seemed to demand a drug or a vaccine to be developed for COVID-19 immediately. The article published with the decoy title ‘Happy Birthday, Clinical Trials! Thank you, COVID-19!’ succeeded in evincing the inquisitiveness of the naive reader and received accolades from doyens in the Clinical Research domain for simplifying the subject using a scenario that anyone could relate to. The second was an invited speech to 500+ attendees on the topic ‘Role of Community Pharmacists and Hospital Pharmacists in Pharmacovigilance’ at a well-structured webinar organized by the South Chapter of the Indian Society for Clinical Research (ISCR) & the Karnataka Registered Pharmacists Association (KRPA) on 23-May-2020. In my lecture (which begins 14 minutes and 20 seconds after the video starts), I passed on the essence of pharmacovigilance as I comprehended it over the years instead of making a regular presentation using slides. It was heartening to hear from the organizers that they liked the approach and the students who participated had commented that they understood what pharmacovigilance is all about. In June, I was fortunate to produce the article ‘Data Handling and Reporting for Ongoing Clinical Trials During COVID-19‘ in my honorary role as the India Regional Editor of Global Forum, a DIA publication. I take this opportunity to thank Nithiya Ananthakrishnan and Priya Govindasamy of Algorics for authoring this insightful account of international significance that has emerged from India. In July, I chaired the first-of-its-kind ‘Pharmacovigilance Awareness Campaign‘ organized by the Pharmacovigilance Council of ISCR, meant exclusively for healthcare professionals (HCPs) involved in patient care (doctors, nurses, pharmacists, paramedics, etc), with Indu Nambiar being the speaker. I see this as a significant step in sensitizing Indian clinicians to pharmacovigilance and the best news about this initiative is that this live webinar will be conducted on a monthly basis by different chairpersons and speakers every month, with the August 2020 session already being open for registration (free but mandatory). Please feel free to share this link with interested HCPs in your circles. To summarize, the first half of 2020 has indeed been very different from the times we have experienced so far. For Oviya MedSafe, it has been a period of monumental growth amidst the fact that COVID-19 has impacted the global economy quite strongly. We express our gratitude to our clients for trusting us during these testing times and are delighted that we have not only lived up to the trust they had on us but have actually set a new benchmark for a reliable service provider in the pharmacovigilance discipline. Above all, we humbly feel a deep sense of fulfilment within, as we have had chances to spread the light of knowledge when there was darkness all around and our endeavors resulted in a palpable difference for the better. Looking forward to meeting you soon with our August 2020 newsletter,

Oviya MedSafe – Standing up for Proactive Pharmacovigilance 172 of 328


August 2020 Dear Well-wishers, On the World Patient Safety Day 2020, I am delighted to post this August 2020 edition (the 95th in the series since April 2012) of Oviya MedSafe‘s newsletter! It is indeed a pleasure that I am able to pass on to you my thoughts for the completed month on this special day. According to the World Health Organization, the objectives of World Patient Safety Day are to increase public awareness and engagement, enhance global understanding, and spur global solidarity and action to promote patient safety. While these objectives are shared goals for all the stakeholders involved, I wish to take this opportunity to highlight the responsibilities of the pharmaceutical industry in this context. Although the terms Patient Safety and Pharmacovigilance are not necessarily synonymous, having a proper pharmacovigilance system in place is the bare minimum that a pharmaceutical company should be doing if it is inclined to honour its commitment to Patient Safety. It is obvious that many companies set up pharmacovigilance departments but such efforts are more often the results of external pressure rather than of their own interest. External pressure not only denotes regulatory mandates but also the business obligations of a company towards its partners. Moreover, not all of such pharmacovigilance departments are as active as they are supposed to be. While ‘compliance-driven pharmacovigilance’ is and should always be the primary focus of the pharmaceutical industry, the true purpose of ‘pharmacovigilance for patient safety’ is not fulfilled unless proactive pharmacovigilance is practised. At the mention of the term ‘proactive pharmacovigilance’, I have often come across the scenario where it was misinterpreted as ‘soliciting safety data’. As pharmacovigilance professionals, all of us know that unsolicited safety data and solicited safety data considerably differ in the weightage attached to them. However, we cannot expect healthcare professionals and/or consumers to report safety data unless they are made aware of what, how, when, why and to whom they should report. While it is mainly the duty of governments to create such awareness, a conscientious pharmaceutical company is expected to extend voluntary support in this direction as the spirit behind the compliance obligation attached to it is that patient safety is of paramount importance. Such positive measures form the foundation for the culture of proactive pharmacovigilance to be built within a pharmaceutical company, with its safety data collection system being the elevation. This is a non-negotiable need even if a company has outsourced the rest of its pharmacovigilance activities. In fact, imparting a sense of proactive pharmacovigilance to a hitherto pharmacovigilance-naive pharmaceutical company is one of the most underrated fundamental duties a pragmatic pharmacovigilance service provider should undertake as soon as they have been contracted. In this context, I am glad to recollect that Oviya MedSafe has grown to be recognized as a champion for the cause of proactive pharmacovigilance time and again. What is more heartening 173 of 328


is that all our clients have often expressed that the customized pharmacovigilance systems we created for each of them have not only fulfilled their compliance needs but have actually enlightened them by demystifying the much feared discipline of pharmacovigilance. Of course, we have come a long way before experiencing this sense of achievement and not before doing our math of balancing the industry’s best practices with the acceptance levels of every client at a micro level. Naturally, this turned out to be a successful Unique Selling Proposition (USP) of ours over the past 8 years and I am sure it will remain so for the future too, as evidenced by our evergrowing list of new customers as well as repetitive business from our current ones. Moving on from the principal topic, I am pleased to share with all of you the article ‘Challenges and Dilemmas of Operationalizing COVID-19 Clinical Research in India‘. It was my pride to facilitate this original content from India on this coveted subject authored by Dr Pooja Sharma and Anirban Roy Chowdhury for the August 2020 edition of Global Forum, a DIA publication, in my honorary role as its Regional Editor for the country. Please click here to read the write-up. As always, feedback is welcomed not only by the editorial board but also by the learned authors. Last but not the least: Let me take the pleasure of inviting you to register for the (virtual) Autumn Conference of the Indian Society for Clinical Research (ISCR) on ‘Clinical Research Landscape – Post 2020‘ organized by the South Chapter of the society and scheduled for 9th and 10th October 2020. Along with Dr Ramesh Jagannathan, I am in-charge for the Pharmacovigilance & Real World Evidence track. The PDF flyer and the intriguing agenda featuring speakers from various countries are available on the respective embedded links. I hope we can get to e-meet during this event Eager to re-connect with you through our September 2020 newsletter,

Oviya MedSafe – Overpowering Brexit-Induced Pharmacovigilance Challenges September 2020 Dear Well-wishers, I am pleased to be able to connect with you today through this September 2020 edition (the 96th in the series since April 2012) of Oviya MedSafe‘s newsletter in the backdrop of the Great British Pharmacovigilance Question that has been answered during the month thanks to the issuance of guidances on the pharmacovigilance system and procedures which are all set to be the reality in the UK in the immediate Post-Brexit era! As we all are aware, the UK has left the EU, and the transition period after Brexit comes to an end this year. The Updated Guidance on Pharmacovigilance Procedures published on 1st September 174 of 328


2020 provides exhaustive details of the arrangements made for everyone to adapt to the “new normal” for pharmacovigilance procedures in the UK with effect from 1st January 2021. According to this document, the MHRA will retain responsibility for pharmacovigilance across the UK but there will be some different requirements for products placed on the market in the UK with respect to Great Britain and Northern Ireland. The term ‘Great Britain’ implies England, Wales and Scotland put together. Products placed on the market in Northern Ireland will need to be in line with EU legislation and follow EU requirements. More details are expected to follow in due course. The Guidance on QPPV including PSMFs from 1 January 2021 published on 4th September 2020 specifically aims to explain the revised pharmacovigilance system requirements. According to this document, the following legal obligations will apply to holders of UK marketing authorisations (MA). These include those that cover the whole of the UK, or are specific to Northern Ireland or to Great Britain (England, Wales and Scotland): 1. To operate a pharmacovigilance system for UK authorised products; 2. To have an appropriately Qualified Person responsible for Pharmacovigilance (QPPV) that resides and operates in the EU or the UK and is responsible for the establishment and maintenance of the pharmacovigilance system for UK authorised products; and 3. To maintain and make available upon request a Pharmacovigilance System Master File (PSMF) that describes the pharmacovigilance system for UK authorised products. The PSMF must be accessible electronically or physically from the UK at the same site at which reports of suspected adverse reaction may be accessed. Apart from these two major guidance documents, a few more operational level advisories have been released for the purpose of pharmacovigilance. They are also available on the MHRA website but the primary demands of regulatory compliance appear to have been covered by and large in these two major guidance documents. Oviya MedSafe, as an organisation, is well-equipped to meet the challenges posed by the newly announced MHRA pharmacovigilance compliance requirements. I believe this is the right time for me to share with you a brief narrative on the growth of Oviya MedSafe as a brand in the UK . After I founded Oviya MedSafe in March 2012 with the organisation’s headquarters at Coimbatore in India, I used to often feel that we needed a European presence in order to provide locationbased services like EU QPPV support, EU Local Responsible Person for PV support, EU Medical Information support, etc. This resulted in the incorporation of Oviya MedSafe UK Ltd (a 100% subsidiary of our parent Indian company Oviya MedSafe Pvt Ltd) in July 2014 at London in the UK. Obviously, UK was very much part of the EU then and we started providing onshore support through our UK subsidiary, as and when required. Over a period of time, Oviya MedSafe’s UK presence became quite pronounced and that was the time the Brexit referendum happened.

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I vividly recall discussing the then unforeseen impacts Brexit may have on Pharmacovigilance in the June 2016 edition of Oviya MedSafe’s newsletter. From there, we all have come a long way and it is delightful to see that much more clarity exists now. Our UK entity has grown over time to such an extent that it is able to provide complete pharmacovigilance services support when required, to not only our UK-based clients but also our EU-based ones. Of course, with hard Brexit done, I sense that we may be justified in considering a separate EU subsidiary for Oviya MedSafe sometime in the future. Keenly waiting to meet you all through the October 2020 newsletter,

Oviya MedSafe – Reminiscing Alongside The Pharmacovigilance River October 2020 Dear Well-wishers, As I sit to write this October 2020 edition of Oviya MedSafe‘s newsletter (the 97th in the series since April 2012), I tend to turn nostalgic about certain happenings in my personal journey in Pharmacovigilance, triggered by a social media reminder of a post I made in October 2008 when I was a young physician from the Clinical Medicine stream who had entered the Pharmacovigilance field just a little more than a year ago. I had then written “I am working in Pharmacovigilance” but when I re-shared the post now, I remarked “When I posted this 12 years ago, I thought I was only working in Pharmacovigilance. I didn’t know that it actually adopted me “, as this was the best way in which I could explain why almost all of my efforts in Pharmacovigilance have been so fruitful all along that a spectator may consider my milestones to have been a string of serendipities! October 2020 began on a happy note for Oviya MedSafe as I was featured in an online initiative of the International Society of Pharmacovigilance (ISoP) named ‘Using Medicines Safely during the COVID-19 pandemic’ meant for patients and caregivers. ISoP developed this campaign to underline the significance of procuring medicines from legitimate sources, acting on undesirable outcomes associated with use of medicines, ensuring adherence with prescribed therapies while maintaining communication with the prescribers, and speaking out against the dissemination of unscrupulous messages about unproven cures for COVID-19. I am glad that I had a chance to be grouped with ISoP members from New Zealand, France, USA, Uganda, Iraq, Germany and Colombia who participated in this activity. Please click here to view the official collage of ISoP’s infographic at our respective workplaces. Although COVID-19 is not a pleasant subject to go on and on about, I need to continue dwelling upon it for just a little more time in this issue, as the forthcoming content is indeed ‘good news‘ (both literally and figuratively) to Pharmacovigilance professionals working in the industry. The 176 of 328


Hindu Business Line, one of India’s most reputed business-focused daily newspapers, published a story titled ‘Demand for Pharmacovigilance services rise amidst COVID-19‘ mentioning me among my colleagues in other organizations. I am particularly proud to state that Oviya MedSafe was one of the only four companies that were approached by the newspaper for insights on the industry trends. I also earnestly thank The Hindu Business Line for allotting enough space to accommodate my views on several aspects of this topic quite elaborately. The news story can be accessed online by visiting this link. During the month, I had an opportunity to serve as the Chair of the Pharmacovigilance Track of the virtual Autumn Conference of the Indian Society for Clinical Research (ISCR) titled ‘Clinical Research Landscape – Post 2020‘. The session brought back memories of October 2008 again, as it was the time when I joined ISCR as a Life Member immediately after attending my first ever event on Pharmacovigilance (a two-day workshop conducted by ISCR at Mumbai). Incidentally, the social media post I mentioned in the opening paragraph of this letter was made in the same month after gaining the confidence that I got to meet at least 100 other Pharmacovigilance professionals working in different organizations. This might come as a surprise to the current generation of entry level Pharmacovigilance professionals, as this field employs more than 20000 people in India alone now! That I later became an Executive Committee Member of ISCR and the Chair of the then newly formed Pharmacovigilance Council (from 2015 until I handed it over to my successor Dr P S Karthik Babu in 2019) seems to be pre-destined when I see this from a third person’s (quite philosophical) view. But, as a rational person, I would rather call it a culmination of my persistent attempts to make Pharmacovigilance a more mainstream word among all stakeholders, a mission that was effectively supported by all Pharmacovigilance enthusiasts I have come across so far. I wish to conclude this communiqué with an invitation to all of you to register for the 7th Annual Pharmacovigilance Symposium of ISCR titled “Pharmacovigilance 2020: Adapting to New Age Patient Safety” which is to be conducted virtually on 3rd and 4th December 2020, in which I will be moderating a Panel Discussion titled “Connecting the Dots in the ADR Reporting Value Chain“. This minimally priced meeting is all set to bring to you reputed international and national speakers/panellists not only from the industry but also those at the helm of affairs at the US FDA and at the Indian Medical Association (IMA). For further details, please refer to the official flyer of the symposium which is available on this web page. Before signing off, let me take the pleasure of wishing all of you and your families a very Happy Deepavali! Waiting to meet you with more intriguing content in our November 2020 newsletter,

Oviya MedSafe – Scaling Peaks as a Pharmacovigilance Evangelist November 2020 177 of 328


Dear Well-wishers, I am heartened to present this November 2020 edition of Oviya MedSafe‘s newsletter (the 98th in the series since April 2012) which is destined to be drastically different from any of my previous missives because I will be more of a speaker rather than a writer in this issue. And, what more? My speech will be in a language other than English yet will of course be about our beloved Pharmacovigilance! But, why is this act even needed now and how does this help? Let us explore the background together before going to the content per se. Throughout its history, Pharmacovigilance has (more often than not) been a possession of the Elite, although not intentionally so. Being a science that directly concerns the health of any person who takes a medicinal product anywhere in the world, it is obvious that the essence of Pharmacovigilance deserves to be taken to the masses with absolute clarity. In fact, making everyone of us comprehend that “even a good drug could do harm” without creating irrational fear of consuming any medicine at all is the primary responsibility of every conscientious Pharmacovigilante. I believe this could have been the idea behind Uppsala Monitoring Centre (UMC) introducing the initiative of “MedSafety Week” a few years ago. During the annual MedSafety Week, UMC teams up with drug regulatory authorities around the world to launch a concerted social media campaign with the hashtag #MedSafetyWeek, which raises awareness of adverse effects of medicines. By this campaign, UMC also aspires to enlighten the community at large about the Pharmacovigilance systems in place worldwide, thereby promoting recognition and reporting of suspected Adverse Drug Reactions (ADRs). The 2020 campaign ran from 2nd to 8th November. It called on patients and healthcare professionals to report all side effects, especially those associated with new or experimental treatments. While UMC released attractive animations for the purpose, I began wondering how I could support the campaign with some original contribution to the cause. And, that is when I spontaneously decided to record a brief video on what Pharmacovigilance is, in Tamil (my mother tongue). I did not have to struggle much to gain my foothold, thanks to Thiruvalluvar (a legendary philosopher who was born just about 2050 years ago), for my mention of the 504th couplet of his classic text “Thirukkural” was more than enough to set the context of my talk. The said couplet (Kural) strikingly illustrated the concept of benefit-risk assessment at a personal level and appeared no less synonymous with the same term when used in the Pharmacovigilance parlance as well. Please click on this link to watch my video and feel free to share it with all your friends and relatives who understand Tamil, regardless of whether they may be healthcare professionals or patients. The option of making an English version of this video is also being considered upon requests from some of my contacts and I hope I will be able to record it sometime soon. I trust this attempt of mine will induce many of my fellow Pharmacovigilantes across the globe to spread the word of Pharmacovigilance in their respective mother tongues, so as to serve as an eye-opener to the fact that medicines do have adverse effects and that they should be 178 of 328


approached with scientific rationale rather than with an emotional mindset. Such ground level changes could significantly augment the Pharmacovigilance Literacy levels of the population. Together, let us all do more like this in order to make ‘Pharmacovigilance’ a mainstream word for the good of the society around us! On the business front, I am excited to share that Oviya MedSafe has been chosen as the exclusive global Pharmacovigilance partner for a clinical trial to be conducted by a EU-based biotech company for a novel therapeutic product for Coronavirus Disease (COVID-19)! While it is unusual for me to share specific updates on the business wins of Oviya MedSafe, this is indeed special because we are going to play an active role in solving a problem that emerged and grew in front of all our eyes to such a monumental proportion! I believe it is truly an opportunity for us to practice ‘Applied Pharmacovigilance‘ and I wish to express my sincere thanks to all of my colleagues at Oviya MedSafe for their respective roles in achieving this milestone. On another note, November 2020 honoured me with the enviable opportunity of facilitating the publication of an unparalleled opinion piece ‘Enabling Real World Evidence (RWE) Studies in India‘ by Dr Arun Bhatt for the month’s edition of DIA’s Global Forum in my role as its Regional Editor for India. I felt greatly privileged at the fortune of having the veteran ‘Editor of Editors‘ as a guest author in an issue that credited me as an editor. And, as I was preparing to end my 2nd term in the role with this grand finale, DIA has pleasantly surprised me by offering a third consecutive term of 2 years (Jan 2021 to Dec 2022) which I have respectfully accepted. I earnestly aspire to produce more such articles relevant to India in future, with all of your support. Before concluding, let me take the pleasure of wishing all of you and your families a Merry Christmas and a very Happy New Year 2021 in advance! Eager to connect with you soon through December 2020 newsletter,

Oviya MedSafe – Maximizing Client Comfort in Pharmacovigilance December 2020 Dear Well-wishers, As we bid adieu to 2020 and begin 2021 with great hope, I am overjoyed to express my heartfelt wishes to all of you and your families for a very Happy & Prosperous New Year 2021, through this December 2020 edition of Oviya MedSafe‘s newsletter (the 99th in the series since April 2012)! This issue aims to particularly focus on Oviya MedSafe’s flexibilities in addressing our clients’ requirements when they approach us exclusively seeking Pharmacovigilance personnel for working on their projects and further aspires to elucidate why choosing Oviya MedSafe’s Project 179 of 328


Outsourcing model rather than insisting on the traditional Contract Staffing model shall work better for any such client of ours. Every department in any organization needs to carry out different types of routine business operations relevant to its industry. While some organizations choose to perform all such tasks themselves by hiring the right people, some others outsource specific activities in full or part to an external agency to the most practicable extent. In the latter case, the external agency is said to be a provider of Project Outsourcing services. However, when an external agency is asked to merely supply competent people who can work as temporary contractors for a defined period of time, the external agency becomes a provider of Contract Staffing services. Pharmacovigilance, as a department in a pharmaceutical company, is no exception to any of these practices. Accordingly, pharmaceutical companies fulfil their regulatory obligations in Pharmacovigilance either by establishing an in-house Pharmacovigilance team or by outsourcing their work as projects to Pharmacovigilance service providers. In addition, Contract Staffing in Pharmacovigilance is in vogue too. A key point to be noted here is that, although Contract Staffing services are rendered by recruitment firms also, clients prefer signing up with service providers having thorough domain expertise when it comes to niche fields like Pharmacovigilance. Oviya MedSafe too receives and services such requests. In a Contract Staffing model, Oviya MedSafe would depute to the client’s project the requested number of designated individuals having relevant educational qualification and training along with adequate experience. As these named individuals would become part of the client’s team itself, everything from that point of time would be the client’s responsibility. No peer Quality Control (QC) support, Quality Assurance (QA) review or Senior Management oversight by Oviya MedSafe would be possible. Further, day-to-day line management of these contract personnel will be an additional burden on the shoulders of the client, with scope for Oviya MedSafe’s involvement being restricted to scenarios in which a given individual has to be replaced for any reason. Most importantly, the knowledge base, effectiveness, ability of managing complex tasks, possibility of prioritizing urgent ad-hoc work and overall productivity of the role itself will be limited to a particular individual’s diligence. Due to this dependence, any planned or unplanned replacement of staff will be accompanied by the client’s apprehensions of consistency in terms of productivity, standards, ways of documentation, work prioritization, and so on. Last but not the least: This model will be more expensive as the staff are dedicated to a single client and no ‘shared services‘ benefit exists. On the contrary, the same work done by Oviya MedSafe in a Project Outsourcing model would be spearheaded by a Project Lead, with a back-up person involved right from the beginning, and both of them reporting internally to their Line Manager within Oviya MedSafe. Additional support in the form of peer QC, QA review & appropriate Senior Management supervision will be extended, as it is Oviya MedSafe’s responsibility to ensure that the deliveries are timely, of high quality, and are in compliance with the not only with the applicable regulatory rules but also with the internal written procedures of Oviya MedSafe and/or the client (as agreed in prior with the client). Thereby, the client is relieved of the pressure of directly managing the project personnel and on 180 of 328


top of it has the assurance of an additional strong layer of protection as the entire Oviya MedSafe hierarchy will duly oversee the project throughout its lifecycle. In contrast to the other model, the client will gain a lot from the mature wisdom of Oviya MedSafe as an organization which includes our comprehensive integrated expertise, established ways of working, structured escalation mechanism, and so on. In the Project Outsourcing model, the system is evidently insulated from the occasional fallacies of any particular individual and vouches for better consistency across all parameters. Over and above all these advantages, this model would eventually be more costeffective for the client as the ‘shared services’ benefit can be passed on to the client. To summarize: Oviya MedSafe fully understands the pros and cons of Contract Staffing as well as Project Outsourcing. While we are fine to be engaged by our clients in either model, I personally feel that the Contract Staffing model gives the client exactly what they WANT but the Project Outsourcing model helps the client better by giving them what they NEED. And, while a client may derive satisfaction from getting exactly what they want (assuming that they know what they want), getting what they need that too in a highly efficient lean manner could be the biggest comfort they could enjoy. As an organization, we desire that the Project Outsourcing model gets better acceptance in future so that we indeed maximize our clients’ comfort in Pharmacovigilance. On the personal front, December 2020 was an exciting month. I was privileged to introduce Dr Gerald J Dal Pan, Director – CDER Office of Surveillance & Epidemiology, US FDA to the audience just ahead of his special address at the 7th Annual Pharmacovigilance Symposium of the Indian Society for Clinical Research (ISCR) and also had the honour of moderating a panel discussion “Connecting the Dots in the ADR Reporting Value Chain” featuring Dr J A Jayalal (National President of the Indian Medical Association for 2021) as an expert panellist in the same event which was conducted virtually. Further, it was my pleasure to engage with Mr Deepak Paliwal, Mr Sumit Arora and Ms Indu Nambiar as the other panellists. I wish to once again thank ISCR for this chance. Outside profession and business too, December 2020 was special for a different reason. For the first time, I literally sang my heart out while wishing one and all for Christmas and for the New Year. It was a heartening feeling to rediscover my singing hobby and use it for wishing my near and dear. While the Christmas song was a famous Tamil film number pertinent to the festival, the one I chose as the New Year song was more from a metaphorical sense reflecting the current scenario of our transition from the challenging 2020 into a promising 2021 during the pandemic. Please click here for my English translation of the Tamil song’s lyrics. Feedback is welcome, as has always been the case! Keen to meet you soon through our January 2021 newsletter,

Oviya MedSafe in Pharmacovigilance – Constructing Credibility by Communicating Consistently 181 of 328


January 2021 Dear Well-wishers, I have no words to express the deep sense of fulfilment I experience today as I sit down to pen the 100th edition (January 2021) of Oviya MedSafe‘s newsletter, a regular writing commitment I made to myself when I logged the first edition in April 2012, barely a month after founding Oviya MedSafe. On this occasion, I trust it is appropriate to share why Oviya MedSafe’s newsletters are felt by our readers to be unique and engaging. To begin with, it was the beginning that made the critical difference. At a time when organizations were already well-versed in pseudo-personalizing their newsletters, we preferred to admit that what we sent was indeed mass communication and instead expressed our optimism by addressing our readers as our well-wishers, a term which no business mailer could have ever opted to use. Yet, we did customize the content in such a way that, although written for a group, it appeared customized to any reader who had even a remote connection to Pharmacovigilance. It was possible because Oviya MedSafe’s primary focus was to bring conversations about Pharmacovigilance to the mainstream rather than looking at making immediate business benefits, thanks to our unceasing zeal for the subject. We treated all our readers as co-travellers in our quest and adopted a personal letter format as against using attractive visual effects, which resulted in a sense of involvement in them. Of course, we too wanted to and eventually did grow our business as any other company, but we derived our biggest pride by responding to our highest calling of contributing to the advancement of Pharmacovigilance as a discipline, more than anything else. While talking about Oviya MedSafe’s offerings, our newsletters always made sure that we not only explained our capabilities but also established how our expertise could add value to our clients. Whenever we wrote about specific support required for certain countries/regions or for particular types of clients, we always provided the context in a succinct manner, which in turn helped decision-makers with little Pharmacovigilance experience too to make the right moves. We never hesitated to elucidate our ways of working in Pharmacovigilance, for we had no doubt in our proficiency. Our newsletters made it a point to describe the current industry practices before detailing how Oviya MedSafe was challenging the status quo. We consciously avoided using industry jargon unless they were absolutely necessary to be used and even when we had to use them, we did so only after defining the terms. Our newsletters not only shared our publications with our readers but also induced leading publishing houses across the globe to reach out to us with requests for exclusive articles on Pharmacovigilance which consequently facilitated us to author many more papers. Apart from these, our newsletters served as the main platform on which we announced our achievements and the recognitions showered upon Oviya MedSafe then and there. In short, it would not be an exaggeration to state that our newsletter editions have chronicled Oviya MedSafe’s evolution over the years and could present themselves as chapters in Oviya MedSafe’s autobiography.

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I do not think I will be justified if I stop my narrative with the authentic impact our straight from the heart newsletters have created in the external world, as the beneficial effects have been enjoyed by our own ecosystem as well. From the time that Oviya MedSafe was an enthusiastic start-up to today when we are a globally renowned brand in Pharmacovigilance, our newsletters have been a constant source of motivation to our team, assurance to our shareholders, confidence to our clients, awareness to our colleagues in the industry, orientation to pharmaceutical professionals outside the Pharmacovigilance domain, and inspiration for students & aspiring future employees of Oviya MedSafe. At a personal level, our newsletters have helped me at an extraordinary level in disseminating information about the educational / advocacy / knowledge-sharing / training / stakeholder-engagement initiatives in Pharmacovigilance which I undertook as an individual or as part of several professional societies that I am associated with. In fact, I feel our newsletters have gifted me with innumerable like-minded friends who are always ready to march with me for the cause of advancement of Pharmacovigilance. At this juncture, I am pleased to unravel our Newsletter Archive which contains the links to all of the 99 newsletter editions we released so far. This archive shall be updated on a real-time basis from now onwards. With a profound sense of gratitude, I dedicate this archive to our loyal readership which has grown from about 300 in 2012 to nearly 30000 in 2021. Please click on http://www.oviyamedsafe.com/news/archive-oviya-medsafes-newsletters/ to access the archive. It will be my pleasure to hear your feedback, if any, on this milestone. Longing to connect with you through our February 2021 newsletter,

Oviya MedSafe – Embedding Pharmacovigilance in the Medical Fraternity February 2021 Dear Well-wishers, Let me begin this February 2021 edition of Oviya MedSafe‘s newsletter (the 101st in the series since April 2012) by thanking each one of you who had replied with your warm compliments on the publication of our 100th newsletter edition last month. It is no exaggeration to say that my drive to connect and be connected with you has remained intact not only because of my determination but also due to your consistent patronage of my writing for which I shall remain ever thankful to you. I am pleased to inform you that the archive of all our newsletter editions released so far can be accessed via this link. As a son of physician parents and as a physician myself, the term Indian Medical Association (IMA) has always been a subject of my adoration as well as an institution close to my heart since my childhood. For the uninitiated, IMA is the largest representative voluntary organisation of Doctors of Modern Scientific System of Medicine (holders of MBBS and/or higher degrees) in India. With a current strength of about 4,00,000 life members, IMA looks after the interests of doctors as well 183 of 328


as the well-being of the community at large. Naturally, IMA was one of the first professional bodies I believed I could turn to in 2010, at the time I started my advocacy measures aimed at taking the concept of Pharmacovigilance to the fraternity of medical practitioners across the length and breadth of India. As I expected, IMA not only embraced the idea but also provided several platforms for me at many levels to emphasize the importance of Pharmacovigilance awareness amongst clinicians, the first of them being a Free Paper presentation I made at the 64th State Medical Conference of IMA Tamil Nadu State Branch on 24th April 2010. Please click here to view some pictures of this historic event. Surprisingly, one of the judges of the session was quite well-informed of Pharmacovigilance and enlightened me about what IMA had been doing for Pharmacovigilance until then, while expressing genuinely critical comments on my presentation, which motivated me to keep voicing about Pharmacovigilance in public in every possible manner. He did not stop with that occasion alone but continued to involve me in several academic initiatives he was leading within the IMA organization. Thanks to the significance he attached to my passion for Pharmacovigilance, other leaders in IMA also took notice of me and recognized my contributions. Over time, after I made a name for myself in the Pharmacovigilance discipline, I invited him to express his views as an IMA representative in various missions I either led or was a key part of. He was gracious enough to accept all my invitations and actively participate in them in spite of responsibilities mounting on him as he grew higher and higher in the IMA hierarchy. At one point of time, he surprised me by nominating me as the Chairman for the Pharmacovigilance Standing Committee of IMA Tamil Nadu State Branch, when he took over as its President. During those times, I became wellpositioned to speak about uniting Prescribing Physicians and Drug Safety Physicians for the cause of Patient Safety, which was the first step towards achieving my Life Goal of making Translational Pharmacovigilance a reality! The judge had judged me correctly indeed The name of the IMA Leader who was the judge of that day is none other than Prof Dr J A Jayalal, the incumbent National President of IMA. At that time, I did not realize that it was serendipity at its best! But now, when he has announced me as the Chairman of the IMA Headquarters Standing Committee for Pharmacovigilance, I understand that the seed for this tree had been sown on that day I first met him! At this moment, I can think only about the following statement Sir Jagadish Chandra Bose made on 30-Sep-1917 while dedicating the Bose Institute to the country: “When one dedicates himself wholly for a great object (cause), the closed doors shall open, and the seemingly impossible will become possible for him.” Of course, this is not the end but is rather a new beginning. With IMA having given me this leadership position along with a stellar set of highly accomplished individuals as distinguished members of the standing committee, I clearly sense the monumental responsibility on my shoulders and comprehend the high level of expectation that IMA has of me. I look forward to doing my best in this role in due course, with the support of all stakeholders of Pharmacovigilance 184 of 328


in India. I take this opportunity to thank my entire team at Oviya MedSafe, especially the key management personnel, board colleagues and shareholders, for allowing me to pursue such nonbusiness interests in Pharmacovigilance without viewing these as potential distractions from my primary role as the Managing Director & CEO of Oviya MedSafe! I am ever indebted to them for their unshakeable trust on my ability to balance my commitments. Moving on from this context, I am happy to present to you a unique article titled Digital Therapeutics (DTx) for Incontinence and Pelvic Pain in India which I had the pleasure of editing for the January 2021 edition of Global Forum (a publication of the Washington DCheadquartered Drug Information Association for which I am the India Regional Editor). Authored by Mr Sanjai Murali and Mr Shyam Ramamurthy of JOGO Health, this succinct report provides an overview of the niche subject from an Indian perspective. I personally believe that DTx as a concept has a bright future in India. Please click here to read the article. Comments are welcome, as usual. Before concluding, I wish to invite you to register for the 14th Annual Conference (Virtual) of the Indian Society for Clinical Research (ISCR) themed “Clinical Research – Transforming Lives: 2021 and Beyond” and to be held on 19th and 20th March 2021. As the Executive Committee Member responsible for the Pharmacovigilance part (which is grouped under Track 2) of this conference, I am excited about the constellation of international speakers and the relevant topics our organizing committee has put together. I am certain that all enthusiasts of Pharmacovigilance will find our sessions engaging and educative. For more information, please download the conference brochure by visiting this link and scrolling down. Kindly note that registration closes on Tuesday 16th March by 4 PM IST. Waiting to meet you through our March 2021 newsletter soon,

Oviya MedSafe – The Evolution of a Niche Pharmacovigilance Nucleus March 2021 Dear Well-wishers, Enjoying the experience of the unsurpassed delight that I gain whenever I connect with you, I start this March 2021 edition of Oviya MedSafe‘s newsletter (the 102nd in the series since April 2012), while recalling the vivid memories of this day on which I released the maiden issue of our newsletter nine years ago. Naturally, it happened within a short period from the time I founded Oviya MedSafe. Yes; you read it right: Oviya MedSafe celebrated its 9th birthday on 14th March 2021, and has just entered its 10th year of life

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As we as an organization prepare to celebrate this milestone throughout the tenth year, I thought of taking this opportunity to share with you why I thought of creating a startup focused on Pharmacovigilance a decade ago and whether Oviya MedSafe as it is today has lived up to the expectations I set for myself as its Founder. As a medical doctor who specialized in Diabetology but serendipitously ventured into Drug Safety, it was only a matter of time before I consciously decided to dedicate myself to Pharmacovigilance. That I had come back to my hometown (Coimbatore, one of the most developed second tier cities in India) and set up my clinical practice before that point in time meant that I could only begin something in the form of training courses. This was quite logical too as the term Pharmacovigilance was almost unheard of in the region then, with the complete absence of the pharmaceutical industry in the city just making the challenge bigger. Nevertheless, the next couple of years of my involvement in introducing Pharmacovigilance to young minds and facilitating the initiation of their careers in the domain sowed the seeds of entrepreneurship in me which led me to conceptualize Oviya MedSafe. That was a time when the outsourced Pharmacovigilance industry was gaining strong foothold in India. However, such business units in Pharmacovigilance were located exclusively in the first tier cities. I wondered why only a few cities had to house this industry whilst there were innumerable educational institutions throughout the country capable of providing staff having relevant qualification for working in the field of Pharmacovigilance. Many of such talented people had logistical, cultural and other practical limitations which made them resist the idea of choosing Pharmacovigilance for a career albeit the industry being ready to hire them immediately if they agreed to relocate. I strongly felt that if Pharmacovigilance activities for compliance with the US FDA or EMA requirements could be performed in India’s first tier cities, it only meant that proper training was provided. Accordingly, I hypothesized that it should not be impossible for such work to be done in second tier cities in India provided that the same standards of training were provided. Thanks to the unshakeable trust we had in what we were doing and with the proactive contributions of our team, we built a self-funded sustainable model. For more details on how our operational model is unique, please refer to our August 2016 and July 2017 newsletter editions (as embedded links). Coming to my assessment of Oviya MedSafe’s journey so far, I can easily say that it was never easy but that has always been the reason for it to be interesting as well. I see today that we have evolved as a Subject Matter Expert organization in Pharmacovigilance, for pharma, CRO and other clients in the space. We are empowered by our strong foundation of domain expertise, which I wish to call as our “niche nucleus” in Pharmacovigilance that has attracted all types of clients to us. Thanks to our women-friendly working environment and excellence fuelled by all our team members, we are poised for exemplary growth. I wish to conclude this letter with a piece of personal good news which I would like to dedicate to my team members for all their support: I have been re-elected to the Executive Committee of the Indian Society for Clinical Research (ISCR) for a 2-year period from April 2021 to March 2023. It is my pride to have been able to serve ISCR as an Executive Committee Member since 2013. I take 186 of 328


this opportunity to thank all my past, present and future colleagues at ISCR for trusting me throughout. On this occasion, I once again resolve to stand firm by my commitment for promoting ethical biomedical practices ranking high on Scientific Temper and consequently for the advancement of evidence-based medicine for augmenting the benefits that humankind can beget of reasoning. With all of your good wishes, I energetically continue my ever-enthusiastic journey towards this long-nurtured ambition, with my passion for Pharmacovigilance illuminating my path ahead, as it has always done since it adopted me! Eager to meet you through our April 2021 newsletter soon,

Oviya MedSafe – Symbolizing Excellence in Pharmacovigilance April 2021 Dear Well-wishers, I am heartened to connect with you through this April 2021 edition of Oviya MedSafe‘s newsletter (the 103rd in the series since April 2012), thanks to the heartfelt compliments you extended to us for having entered into our 10th year of life as an organization. In this issue, I wanted to highlight a couple of our recent achievements and underline how our flair for excellence has always been instrumental in ensuring our growth. On 30-Nov-2020, I announced that Oviya MedSafe had been chosen as the exclusive global pharmacovigilance partner for a clinical trial of a EU-based biotech company for their novel therapeutic product for Coronavirus Disease (COVID-19). The study is in full swing now and we as a team are proud of the meaningful contributions we have been making in defining the safety profile of an innovative treatment option for this unprecedented condition. Today, I am prouder to state that Oviya MedSafe has recently won a similar positioning with another renowned multinational clinical trial sponsor that is developing a promising vaccine for COVID-19. When the whole world is in search of preventive and therapeutic agents to address this indication, we feel privileged to be able to have been involved in the scientific quest for both. Amidst the unenviable situations many of us have been forced into because of this mammoth problem, we derive a sense of fulfillment in that our organization has been able to become part of the solution, radiating hope to our suffering brethren. At this time, I am reminded of how my individual virtue of excellence got noticed for the first time in my professional life and how I being appreciated for exhibiting excellence at my workplace as a postgraduate medical student not only paved way for a phenomenal change in my career but also ingrained excellence as a key tenet in Oviya MedSafe, the organization that I later created. I 187 of 328


believe that my desire and decision to pay forward to my team members the motivation I received from my teacher is indeed the direct reason for this evolution. Very few would be privileged enough for this to be documented, not by the student but rather by the teacher himself. I am pleased to share with you the verbatim account as follows: // I once noticed that one of the fellows took detailed, elaborate notes. He clearly had a talent for writing, which seemed to be far above that of the other fellows. One day, when I saw him write, I casually told him, ‘I think you have the makings of a writer in you.’ The kind, encouraging words of seniors can often have a life-changing impact on young practitioners-and that’s exactly what happened. After the fellow completed his course, instead of practising diabetes full-time, he took up pharmacovigilance (a field that involves the preparation of copious amounts of written records) and immersed himself in intensive research on drugs. In subsequent years, he rose through the ranks in his chosen field and won a lot of recognition. // The above excerpt is from the Penguin-published book ‘Making Excellence a Habit‘, an autobiography of India’s leading diabetologist Dr V Mohan, whom I have been fortunate to have as my teacher. One of the few practising doctors in India who has contributed to research, education and charity in such a large measure, ‘Making Excellence a Habit‘ documents the fundamentals of what makes a person achieve meaningful success. Irrespective of the mention about me, I found this book to be a phenomenal source of encouragement to any young person daring to dream big in life. If you wish to own a copy of this book and get inspired to achieve much more in life, please visit this link. My joy doubles at this juncture, as I also had the honour of inviting Dr V Mohan to write on “Are Antidiabetic Drugs Safe in the Long Term?” for the March 2021 edition of Global Forum, a Drug Information Association (DIA) publication for which I am the India Regional Editor. That I have been able to edit an article penned by the person who taught me to write scientific papers speaks a lot about his generous professionalism rather than my evolved proficiency. Kindly click here to read this opinion piece. Before concluding, I wish to inform you of two virtual events that I am actively involved in and would like to you to consider attending. The first is a webinar organized by the Indian Medical Association’s (IMA) Standing Committee for Pharmacovigilance of which I am the Chairman. Scheduled for the 4:30 pm to 6 pm IST slot on Thursday 20th May 2021, the International Clinical Trials Day, the webinar will have Dr Nilima Kshirsagar, Emeritus Scientist & Former National Chair of Pharmacology, Indian Council of Medical Research (ICMR) speaking on “The Role of Clinical Trials in Assuring the Safety of Medicines“. Please click here for the Zoom link to join the webinar. No registration is required. The other event I mentioned is titled “International Pharmacovigilance Days 2021” and is scheduled for 14-18 June. I have been invited to represent India as a panelist in the roundtable 188 of 328


session “GVP-like legislation outside Europe: overlap and differences“. It is my honour to get yet another opportunity to showcase India’s achievements in pharmacovigilance on an international platform. Kindly visit the event website for details on registration and the fees Waiting to meet you through our May 2021 newsletter,

Oviya MedSafe – Scriptwriting Pharmacovigilance and Directing Compliance May 2021 Dear Well-wishers, I am pleased to reach out to you through this May 2021 edition of Oviya MedSafe‘s newsletter (the 104th in the series since April 2012) in which I intend to share with you some of my perspectives on what the cornerstone for good pharmacovigilance in any organization is. Yes! You guessed it right: I am talking about the existence, adequacy, relevance, implementability and evaluability of written procedures. Written procedures are of many forms such as standard operating procedures, work instructions, guides, manuals, policies, conventions and so on. These are pretty standard terms with unique definitions available in public domain and are used across many industries in the context of their quality management systems. While written procedures are considered “good to have” in many industries, pharmacovigilance is one of those sensitive fields where these are absolutely “need to have“. In several pharmacovigilance inspections across the world, findings related to written procedures have arguably been the most common as well as the most critical ones. This unfortunate state of affairs, especially in many small and mid-size pharma/biotech companies, appears to be an outcome of their tendency to undermine the significance of having solid written procedures in place. It is analogous to a movie producer asking his director to begin shooting without a script in hand at all, or having written just the plot summary with not much effort invested in finalizing the setting of the story, sketching the characters, planning the schedule and taking opinions from interested third parties. We all know how important a meticulously written script is to a movie that exhibits quite a lot of detail. Not just the main knot but in fact every key element in a movie needs to be conceived and visualized in prior. The conversations between characters, leitmotifs, body languages of the artistes, backdrops in each scene, and everything else would sound logical only if they are within the scope of the script. While having a good script does not guarantee a good movie by itself, not having a script at all is definitely a journey towards failure, even if the director is seasoned and is confident of going extempore on the sets. Pharmacovigilance is quite similar to a movie that warrants tremendous attention to detail and no amount of professional seniority can compensate for the lack of proper written procedures. In other words, it is the strength of the system that matters in pharmacovigilance rather than that of any particular individual. Akin to how directors 189 of 328


have intense brainstorming sessions with their scriptwriters to make the movie better than themselves, the role of strong individuals working in pharmacovigilance is actually to collaboratively develop a pharmacovigilance system that is stronger than all of them put together. In short, just as the script enables direction in cinema, written procedures direct pharmacovigilance in an organization. Further, properly performed pharmacovigilance ensures regulatory compliance just like how a well-directed movie achieves its target of engaging the audience. Since 2012, Oviya MedSafe has written many such tight scripts for other directors (consultancy services in pharmacovigilance), directed scripts of others to their delight (outsourced pharmacovigilance activities according to our clients’ written procedures), and been the successful scriptwriter & director for our producers (clients) who totally entrusted their movies (hybrid model of consultancy & outsourced services in pharmacovigilance) to us. Occasionally, we have also been consulted for third party opinions (performing gap analysis in pharmacovigilance) by other scriptwriters and directors for their own movies at various stages of production, as pharmacovigilance is a movie that always has to enthral the viewers. We have been phenomenally successful in all these roles thanks to our team members who never get tired of facing new pharmacovigilance challenges on behalf of our clients and instead always enjoy the process of identifying solutions for their problems. As an organization that loves pharmacovigilance, Oviya MedSafe is heartened to state that more than 50 clients (pharma, biotech, vaccine, CRO & technology companies) have benefited from our pharmacovigilance offerings and we warmly invite you too to experience our expertise. The month of May has always been special since the time I became part of the clinical research discipline, thanks to the International Clinical Trials Day which is observed on 20th May every year. On this day in 2020, I wrote a short LinkedIn article “Happy Birthday, Clinical Trials! Thank you, COVID-19!” as a response to my friend who demanded a COVID-19 vaccine. Within this one year, Science has proven to everyone what it is capable of, by bringing out quite a few vaccines already and assuring that many more are in the pipeline. Many clinical trials have been conducted to prove the safety and efficacy of various COVID-19 treatment options as well. These speak volumes of the hard work done by hundreds of scientists during all stages of research & development that deserve to be celebrated on par with our frontline COVID warriors. On this occasion in 2021, I had the privilege of emphasizing this point to the entire physician fraternity across India in my honorary capacity as the Chairman of the Indian Medical Association (IMA) Standing Committee for Pharmacovigilance, by organizing a talk by the renowned Dr Nilima Kshirsagar on “The Role of Clinical Trials in Assuring the Safety of Medicines“. The 90-minute programme was well-attended and applauded by all the participants for the useful content. If you wish to watch the recorded webinar, please click on this link. I am excited to inform you that we are all set to conduct the next session on behalf of the IMA Headquarters Standing Committee for Pharmacovigilance on a very attractive topic “Medico Legal Aspects of Adverse Drug Reactions” by Dr Subhrojyoti Bhowmick. The webinar is scheduled for 190 of 328


Tuesday 22nd June 2021 from 5 pm to 6:30 pm IST. The Zoom link to join this webinar is https://bit.ly/3gv8bTA. Please do add this event to your calendar if you wish to be part of this novel and intriguing initiative from the IMA. Looking forward to connecting with you through our June 2021 newsletter,

Oviya MedSafe –Emanating Holistic Pharmacovigilance Wisdom June 2021 Dear Well-wishers, Brimming with the enthusiasm I derive by connecting with all of you, I pen this June 2021 edition of Oviya MedSafe‘s newsletter (the 105th in the series since April 2012)! In this edition, I wish to speak about one of our niche areas of expertise which evolved from the comprehensive approach Oviya MedSafe adopted towards Pharmacovigilance right from the beginning, and has turned out to be extremely successful in strategically solving complicated pharmacovigilance problems faced by some of our clients that are leading multinational pharmaceutical companies. Let me start by recollecting the occasion which made me realize that this topic would be worth elucidating, namely the annual conference ‘International Pharmacovigilance (PhV) Days‘ organised by LS Academy, Italy from 14th to 18th June 2021. I was invited to represent India in the roundtable session “GVP-like legislation outside Europe: overlap and differences” in this virtual event during which I enjoyed the insightful interactions with the moderator Martijn van de Leur and my co-panelists Dr Lidia Maksyutkina (Russia/CIS), Mina Awad (Middle East Asia) and John Barber (UK). The roundtable session clearly brought out the unique features of pharmacovigilance activities required to be carried out at local/regional affiliate levels and the challenges involved in aligning the strategies of individual units with the corporate pharmacovigilance policies of the organization. Apart from such country-specific or region-specific pharmacovigilance requirements, it is understandable that any kind of business transformation that a pharmaceutical company undergoes too would warrant mature pharmacovigilance expertise for ensuring smooth transition. Such instances could include stages like mergers/acquisitions, management restructuring, inspections at the affiliate level, change of focus products/markets, new pharmacovigilance partners, etc. In any of the above-mentioned scenarios, relevantly qualified and reasonably experienced pharmacovigilance professionals would be required in order to thoroughly analyze the way forward and then drive appropriate action on behalf of the pharmaceutical company, especially for a defined short to intermediate period of time. Even though pharmaceutical companies can have this role in-house, they prefer to outsource it considering the contract nature of the role and its comparatively shorter period of engagement. Further, having this role itself outsourced to a third party gives the client the ability to empower this candidate to dispose their duties with full 191 of 328


authority as if they were a totally independent person which would practically seldom be the case if the client directly employed this candidate. Now, for the most important point: What matters is not just the length of the experience the target candidates have in pharmacovigilance but also the types of activities they are proficient in handling. It is here that people who have worked purely in operational roles in pharmacovigilance may not be of help. Instead, prior experience in handling strategic pharmacovigilance activities, particularly the ability to liaise with their large scale global service providers in pharmacovigilance would be invaluably helpful. We at Oviya MedSafe have always ensured that our cross-sectional grasp of pharmacovigilance has cascaded right to the newest member of our team and stand out as a natural choice for such projects. Oviya MedSafe has always been a proponent of practising participative management at the workplace and with our prowess in providing such carefully selected pharmacovigilance experts as specialist consultants for our clients; we firmly believe that we have everything in place to support such client requirements. We already have quite a few multinational pharmaceutical clients in this specialised consultancy model and aspire to develop this into a separate vertical, considering the fact that there are many experienced pharmacovigilance professionals in India who wish to take up such challenging assignments. Leaving you with this thought, I would like to conclude this month’s note, of course not before sharing with you the recording of the 90-minute webinar ‘Medico Legal Implications of Adverse Drug Reactions‘ I moderated in my honorary capacity as the Chairman of the Indian Medical Association (IMA) Headquarters Standing Committee for Pharmacovigilance, featuring Dr Subhrojyoti Bhowmick and Ms Binota Roy (Advocate) as the expert speakers. Please click on https://youtu.be/UKHbc6SQsm8 to watch the recorded webinar. Kindly feel free to share your feedback with me in reply and do participate in our future initiatives. Waiting to meet you through our July 2021 newsletter shortly,

Oviya MedSafe – Caring for Pharmacovigilance with Commitment July 2021 Dear Well-wishers, The first day of July every year is significant for any doctor in India, as they (especially clinicians) receive loads of wishes from their patients and the public on account of National Doctor’s Day, celebrated in memory of Dr Bidhan Chandra Roy. Even though I happened to become a Pharmacovigilance Physician pretty much in the early days of my medical career, the observance has continued to remain important to me. Much more than ever before, 1st July 2021 meant a lot to me, for it marked the silver jubilee of my entry into the field of Medicine. In this context, I am overjoyed to share my feelings with you through this July 2021 edition of Oviya MedSafe‘s newsletter (the 106th in the series since April 2012)! 192 of 328


It was on this day in 1996, I joined the MBBS course at Coimbatore Medical College, not once foreseeing anything beyond a conventional clinical career then, being a son of a typical doctor couple in India. When I sat to recall my professional journey of the past 25 years, I realized that my life has had in store for me key turning points almost once in every 5 years. Each block of 5 years propelled me into a unique phase and made me don a different role, powered partly by serendipity and mainly by my keenness to relentlessly try the road not taken. It was heartening for me to recollect that during the Doctor’s Day season in 2016 (the end of my 4th block of 5 years), I was recognized as a Leader in Pharmacovigilance by the Coimbatore Branch of the Indian Medical Association (IMA, the largest representative voluntary organization of Doctors of Modern Scientific System of Medicine) and on the same occasion in 2021 (the end of my 5th block of 5 years) now, I hold office as the Chairman of the IMA Headquarters Standing Committee for Pharmacovigilance, for which growth I remain thankful to everyone and everything that I encountered throughout my journey. As much as I would like to document all these experiences, I did make out that it could warrant a lengthy book. Particularly, my learnings in founding Oviya MedSafe as a Pharmacovigilancefocused organization in 2012 and steering it into its 10th year will need several chapters. Hence, I thought of narrating how my uncompromising efforts in challenging my comfort zones throughout accompanied by my strong adherence to certain core values at every point in life contributed to my professional growth, as a video post. Titled “25 years in Medicine: What made me what I am today“, this extemporaneous and obviously unedited video runs for just about 12 minutes. I believe this brief reflection of the path I traversed so far may enable younger generations to feel more encouraged about and confidently pursue their dreams for which they have been made for. The fundamental point I wanted to highlight was: “Do not compare yourselves with others, for everyone’s journey is different“. Please click here to watch the video. Comments are welcome, as always! Let me move on to the next subject of this issue: a guest column titled “Pharmacovigilance as an Indispensable Ingredient for India’s Pharma Growth Formula” which I was invited to author for the 19th anniversary edition of Pharma Bio World (PBW), a leading pharmaceutical industry magazine based in India! I wanted to write on this topic because I have always felt that Pharmacovigilance is an enabler for the growth of the pharmaceutical industry, in spite of it not being a view that many share. In fact, I have made the following claim in the article, which I am not sure if anyone else already has: “Although the pharma industry has been known to exist for centuries, it would not be an exaggeration to state that the emergence of Pharmacovigilance as a Science and consequently as a Regulation particularly in the past 60 years has made medicinal products much safer and more effective for the patients, thereby enhancing public confidence on the accountability of the industry.” 193 of 328


I hope this snippet induces you to read the paper in full. Please click here to view/download the article. To read this guest column in the July 2021 issue of Pharma Bio World in their original flipbook format, please visit this URL. My article in the flipbook runs from page 46 to page 49. I am keen to hear any opinions you may have on the perspectives that I have put forth in this publication. Eager to re-connect with you through our August 2021 newsletter,

Oviya MedSafe – Dignifying Pharmacovigilance Globally August 2021 Dear Well-wishers, While the Pharmacovigilance fraternity across the world celebrates the World Patient Safety Day 2021 today, I am enthused to connect with you through this August 2021 edition of Oviya MedSafe‘s newsletter (the 107th in the series since April 2012) carrying my message for the completed month! All of us would agree that doing something simple which rightly influences the thought process of the masses will usually be much more beneficial to the community at large rather than talking about cutting edge stuff which very few experts may be able to relate to. August 2021 began with such an effective step for me as I had the opportunity to organize (on behalf of the Indian Medical Association HQ Standing Committee for Pharmacovigilance that I am the Chairman of) a scintillating speech on “What happens when doctors report reactions after COVID vaccination?” by Dr Madhava Ram Balakrishnan (Medical Officer – Global Vaccine Safety, World Health Organization HQ, Geneva), meant for clinicians. I am delighted to share some screenshots from the interactive webinar which attracted more than 130 participants, providing immense insights to them and answering many of their questions on the subject. From day one, Oviya MedSafe has not only been a business enterprise in Pharmacovigilance but instead came to be recognized amidst our network as a brand ambassador for the significance of Pharmacovigilance, thanks to our natural flair for the discipline. Wherever we went, we took to the audience our contagious fervour that in turn made us synonymous with Pharmacovigilance, especially for the non-industry healthcare professionals in clinical practice. Though it is true that a great extent of this public perception of Oviya MedSafe is attributable to my well-recognized performances in honorary leadership roles in several professional societies over the years, I can never afford to undermine the extraordinary level of alignment my team has had with my vision and the stupendous efforts all of my team members have put in to travel with me in this mission, never once compromising on any of our core values. With all humility, what more can I do to express my gratitude to them other than dedicating my next big milestone in their favour? 194 of 328


I take a lot of pride in dedicating to Oviya MedSafe team the most recent honour that the Drug Information Association (DIA) has bestowed upon me: Editor of a Special Section on Global Pharmacovigilance & Safety, for a 4th quarter 2021 issue of Global Forum (a DIA publication for which I have been serving as the Regional Editor for India since April 2017)! In this role, I have been entrusted with the responsibility of sewing together a wide range of pertinent articles on contemporary/futuristic topics in Pharmacovigilance from different parts of the globe. On this occasion, I wish to thank Dr Alberto Grignolo (Editor-in-Chief of Global Forum) and the entire DIA Editorial Team (particularly Mr Chris Slawecki) for handpicking me for this distinguished assignment. As we know, post-marketing Pharmacovigilance and Drug Safety have always been a hallmark of DIA’s regional and global educational offerings, in strong alignment with DIA’s constituents’ interests and priorities. Since the pandemic, they have also become a more pressing feature of global public health discussions. Hence, we may have no better time than this to bring up such points for discussion. Considering that Dr Grignolo’s personalized communications to internal DIA stakeholders have already resulted in quite a number of interesting topics proposed by renowned experts, I believe that I will be able to meaningfully contribute to DIA as Editor of this Special Section with your support. Please keep watching this space for more information in due course. Eager to meet you soon with Oviya MedSafe’s September 2021 newsletter,

Oviya MedSafe – Celebrating Pharmacovigilance with Pride September 2021 Dear Well-wishers, As I begin chronicling the various Pharmacovigilance events I was involved in during September 2021, for this edition of Oviya MedSafe‘s newsletter for the corresponding month (the 108th in the series since April 2012), I could not help recalling my fond memories of Oviya MedSafe’s early initiatives in celebrating Pharmacovigilance long before the recently established national (Indian) and international Pharmacovigilance observances came into existence. Please click here to read our July 2019 newsletter edition for more details in this regard. World Patient Safety Day which is observed annually on 17th September became a little more special in India in 2021, as it also marked the beginning of the first ever National Pharmacovigilance Week (17th to 23rd September 2021) announced by the Indian Pharmacopoeia Commission (IPC), the National Coordination Centre of the Pharmacovigilance Programme of India (PvPI). Apart from IPC, many organizations and institutions across the country celebrated the 195 of 328


National Pharmacovigilance Pharmacovigilance in India.

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As the first of my activities in this season, I delivered an invited lecture on the topic “PostMarketing Pharmacovigilance Activities: An Overview” at the virtual workshop organised on 17th September by the Association of Community Pharmacists of India (ACPI) & CliMed Research Solutions! My lecture can be watched on this YouTube link (first one hour). I express my sincere thanks to the organizers (especially Dr Arulkumaran) of this virtual workshop that helped me reach out to young professionals across India on the fundamentals of Pharmacovigilance. Moving on, I was invited to speak on “Life with Pharmacovigilance” at the National Pharmacovigilance Week 2021 celebration webinar organized by the reputed College of Pharmacy, Sri Ramakrishna Institute of Paramedical Sciences, Coimbatore on 20th September. I felt truly honoured that Dr T K Ravi, one of the most renowned academicians in the Pharmacy field in India (and the Principal of the college) not only introduced me with generous words but also listened to my talk completely and asked questions at the end. I thank Dr S Sriram and the entire organizing team for inviting me to take up this privilege. It was heartening to hear from the participants that they found the talk interesting and useful. Please click here to view some snapshots from the event. Last but not the least; I come to the virtual event that I initiated on 22nd September for the Indian Medical Association (IMA) Headquarters Standing Committee for Pharmacovigilance. Titled “Working Together in Pharmacovigilance for Patient Safety” and structured as a panel discussion involving key stakeholders of Pharmacovigilance in India, the session had distinguished personalities Dr Rajeev Singh Raghuvanshi (Secretary cum Scientific Director, IPC), Dr Sanish Davis (President, Indian Society for Clinical Research), Dr Usharani Pingali (Professor & Head of Clinical Pharmacology and Therapeutics, Nizam’s Institute of Medical Sciences, Hyderabad) and Dr N K Subramanya (Professor of Paediatrics, Vydehi Institute of Medical Sciences, Bengaluru) as panellists representing their respective stakeholder community, with I moderating it. It was a wonderful occasion for the audience to understand the various facets of Pharmacovigilance from the concerned experts themselves. To watch the entire 2-hour session on YouTube, please click here. I need to particularly acknowledge the kind gesture of Dr J A Jayalal, respected National President of IMA, who inaugurated the above session in the presence of Honorary Secretary General Dr Jayesh Lele even as they were travelling together for an IMA function. As the Chairman of the IMA HQ Standing Committee for Pharmacovigilance, I remain ever thankful to them for their constant encouragement and support. Let me conclude by sharing with all of you an article titled ‘Building a Patient Safety Culture in India‘ written by Ms Arshia Bhandari and published in “Uppsala Reports” (an official publication of the Uppsala Monitoring Centre) on 24th September 2021, as it features my quotes on behalf of IMA. I am additionally happy for the fact that this write-up has also touched upon the pioneering steps taken by the Indian Society for Clinical Research (ISCR, whose Pharmacovigilance 196 of 328


Council I chaired from 2015 to 2019) for promoting Pharmacovigilance awareness in India. Please click here to read this article. Thanking you so much for your patient reading and continued interest in our newsletter, Keen to re-connect with you through our October 2021 edition,

Oviya MedSafe – Unlocking the Paradise of Pharmacovigilance October 2021 Dear Well-wishers, I am overjoyed to present to you this October 2021 edition of Oviya MedSafe‘s newsletter (the 109th in the series since April 2012) which talks about an important step we have taken in the interest of guiding the next generation of aspiring Pharmacovigilance professionals to begin their career journey. “Let the World get the same Bliss that I got“, proclaimed the ancient Tamil Saint Thirumoolar in his literary classic ‘Thirumandhiram‘. Having heard the original Tamil verse quite frequently since my childhood, I have invariably been inclined to explore the pleasure of sharing my joy with my kith & kin. Professionally, I made it a point to implement the same philosophy within Oviya MedSafe as one of the core values of the organization from day one. Thanks to my wonderful colleagues, learning and teaching Pharmacovigilance has been a beautiful and enjoyable experience at Oviya MedSafe all the time. Although Oviya MedSafe is a leading provider of global Pharmacovigilance consultancy & outsourced Drug Safety services today, we take pride in being an academically sound institution as well. The reality that our training endeavors were meant only for our staff, clients and collaborators made us ponder many a time on how better we could take the essence of Pharmacovigilance to the community such that they could benefit from its grace as much as we did. October 6th, 2021 was the day that made us feel satisfied of having made a beginning in this aspect. It was on this day that we signed up to provide Pharmacovigilance internship support to The Whiteboard, a leading academy for training professionals in the field of clinical trials and drug development, for their PV-Pro course. Accordingly, aspiring pharmacovigilance professionals who enroll for this course shall be entitled to undergo a structured internship program at Oviya MedSafe, after successfully completing their classroom sessions at The Whiteboard. During the internship period, the candidates would get hands-on experience on an industry-standard Pharmacovigilance software database (an exclusive sandbox version containing no client-confidential data), under the supervision and mentorship of seasoned Pharmacovigilance staff of Oviya MedSafe. We believe that apart from addressing the dearth of trained Drug Safety professionals in India (in the backdrop of the huge demand that is now being seen in the industry), 197 of 328


this step will also enable us to scale up Oviya MedSafe’s operations which is an inevitable measure considering the rich pipeline of clients we have. Please click here to read our joint press release with The Whiteboard. For course enquiries, kindly contact The Whiteboard directly. On the personal front, the month gave me an opportunity to lead a roundtable session on the topic “Interpreting Indian Pharmacovigilance Regulations & 2018 Guidelines” at the 8th Annual Pharmacovigilance Conference of DIA India held virtually. It was an interesting platform to discuss this challenging topic with industry colleagues from several organizations. I am thankful to DIA (Drug Information Association) for consistently involving me in the Program Committees of this conference every year since 2016. Having had the chance to be associated with DIA through the years in various roles is by itself a feel-good factor I cherish. Before concluding, let me take the happiness of inviting you to register for the 8th Annual Pharmacovigilance Symposium (virtual) of the Indian Society for Clinical Research (ISCR), on behalf of the Organizing Committee of the event. This year’s symposium will be conducted as a two-day webinar with the theme “Redefining Pharmacovigilance Frontiers for Augmenting Healthcare”, on 2nd & 3rd December 2021. This cost-effective event has acclaimed Pharmacovigilance professionals from different parts of the world as Speakers and Panelists. The agenda with the details of the Faculty and the modus operandi for the registration is available on this link. Eager to meet you through our November 2021 newsletter soon,

Oviya MedSafe – Diligent Pharmacovigilance Support for Clinical Trials November 2021 Dear Well-wishers, I am pleased to reach out to you through this November 2021 edition of Oviya MedSafe‘s newsletter (the 110th in the series since April 2012) in which I intend to speak about our recent achievements in providing Pharmacovigilance support for Clinical Trials. Although Oviya MedSafe has had Clinical Trial Safety Management in our list of offerings ever since we began our journey, most of our deliveries were predominantly in the Post-Marketing Pharmacovigilance space. We did have opportunities to work on Patient Safety Narratives for Clinical Study Reports and in Safety Monitoring of Patient Support Programmes & Market Research Programmes, which I had written about in quite detail, in 2015 and 2016. Apart from these, most of our clinical trial safety tasks were performed as part of a wider scope of comprehensive pharmacovigilance consulting assignments. Interestingly, things have changed a 198 of 328


lot in the past few years, with many new international clients signing up with us for a bundled provision of regulatory-compliant pharmacovigilance software database deployment with longterm contracts for Oviya MedSafe staff to process and manage their clinical trial Serious Adverse Events (SAEs). While COVID-19 and its associated clinical trials could have been one of the reasons for the global demand for such services to pick up, I believe the situation also helped the market realize the significance of having a committed Pharmacovigilance partner like Oviya MedSafe. Having had the experience of working with both established pharmaceutical companies as well as promising biotech start-ups, Oviya MedSafe fully understands how Pharmacovigilance in each clinical trial has to be treated differently while remembering that the core similarities do not change. Right from protocol finalization along with the client, Oviya MedSafe team invests quite a lot of time in crafting the Safety Management Plan (SMP) to make sure that every role, responsibility and timeline pertaining to the trial’s SAE Management are clearly defined. Oviya MedSafe’s dedicated Medical Safety team comprising of physicians takes care of the causality assessment and other medical review aspects while the Pharmacovigilance Operations team ensures that the SAEs are processed methodically in the system and the independent Quality Assurance team maintains thorough oversight of the entire process. Oviya MedSafe’s domain strength in regulatory compliance, technical prowess in global SAE submission procedures, structured Quality Management System, documented conventions of various case scenarios, and direct oversight of senior management have made us a trustworthy SAE Management partner for all types of clinical trial sponsors from different parts of the world. In fact, quite a few Contract Research Organizations (CROs) which run clinical trials on behalf of their sponsors have completely entrusted us with the Pharmacovigilance part with the approval of their sponsors, which I see as a phenomenal credential for Oviya MedSafe. I was glad to have a chance to utilize our expertise in this subject for delivering a short talk on “Causality Assessment in Clinical Trials” to a group of Ethics Committee Members at the workshop titled “Good Clinical Practice and Regulatory Updates in Clinical Trials” organized by the Indian Society for Clinical Research (ISCR) at Coimbatore on 20th Nov 2021. I was happy to speak at a ‘real’ (non-virtual) event after almost 2 years and it was so heartening to meet colleagues face-to-face. As a Pharmacovigilance professional, I think there is always scope for improving dialogue among all stakeholders, especially in the clinical trial scenario where clear documentation, which is a function of clear understanding, is the key. I was also fortunate to be invited to give a lecture on “Role of Healthcare Professionals in Pharmacovigilance” at the 19th Skill Development Programme on Pharmacovigilance for Medical Products, organized by the Indian Pharmacopoeia Commission, Ghaziabad during the month. I wish to conclude with something special: the recording of a webinar I organized on 23-Nov-2021 in my honorary capacity as the Chairman of the Indian Medical Association Headquarters Standing Committee for Pharmacovigilance. Moderated by Dr Pooja Sharma, the webinar titled “Drug Safety in Pregnancy & Lactation” had Dr Meenakshi Dua, Dr Sreelaxmi Kodandapani and Dr Nipun Patil as the expert panelists. Please click on https://youtu.be/a4j7Zf302q4 to watch it. Feedback is welcome. 199 of 328


I look forward to meeting you soon through our December 2021 newsletter. Wishing you Merry Christmas and a Happy New Year 2022 in advance,

Oviya MedSafe – Earning Respect For Pharmacovigilance December 2021 Dear Well-wishers, As we step into 2022 with immense optimism for a better future, I am glad to connect with you through this December 2021 edition of Oviya MedSafe‘s newsletter (the 111th in the series since April 2012) in which I wish to share with you some noteworthy appreciations from our new clients in 2021. The year 2021 was phenomenal for Oviya MedSafe as it brought to us a wide variety of Pharmacovigilance projects with most of them being overseas assignments. Although versatility is not new to Oviya MedSafe, the leagues of clients that we worked with in 2021 and the symbiotic business relationships we built with them in the process have assured us that much bigger achievements are in store for us in 2022 and beyond. Another rewarding aspect we noted in 2021 was that most of such clients, regardless of whether they were innovators or generic pharma, did not hesitate to sign long-term contracts with us even though their products were quite early in the life cycle, thereby confirming their trust in Oviya MedSafe as a reliable global Pharmacovigilance partner. One of such clients is an emerging Marketing Authorisation (MA) Holder in the United Kingdom (UK) whom we have been assisting with all their Pharmacovigilance requirements right from the dossier preparation stage, including UK Qualified Person for Pharmacovigilance (QPPV) support. Having grown organically over the past decade, Oviya MedSafe is very well-positioned to understand the challenges of a self-funded start-up and proposed a flexible long-term financial model which ensured little burden on the client during their fledgling stages. With their MA approvals round the corner, the client now happily looks forward to do further business with Oviya MedSafe. On the other side of the spectrum, Oviya MedSafe was chosen by a large & leading multinational healthcare products company to set up a corporate Pharmacovigilance system and integrate it with their established Medical Information department in order to achieve total regulatory compliance. What started with a multipronged approach comprising of consulting, training and auditing elements, culminated in a holistic Patient Safety Practice in the organization. We are all 200 of 328


set to begin running their global Pharmacovigilance system on their behalf shortly. Here also, our novel approaches resulted in deep-seated satisfaction for the client as well as ourselves. From the above two representative samples, what I intend to highlight is that we have succeeded in our endeavours not just because of our rich expertise in the domain but also because we have the ability to customize our offerings to address the specific business challenges of each client in a cost-effective manner. While this does sound to be a logical strategy that any prudent business house will adopt, I believe such ideas would flow in only when we are passionate about what we do and also work with an efficient team that enjoys solving such problems, just as what we are and have at Oviya MedSafe To quote the words of the great visionary philanthropic ophthalmologist of India Dr Govindappa Venkataswamy (Dr V), “Intelligence and capability are not enough. There must be the joy of doing something beautiful.” Moving on to my personal pursuits in Pharmacovigilance, I am pleased to share with you a video recording of my invited interactive short lecture at CIMACON 2021 (the annual State Medical Conference of the Indian Medical Association Tamil Nadu State Branch) at Coimbatore on 11th Dec 2021. While my original talk had been titled “Pharmacovigilance & Drug Safety – An Introduction“, I now feel it could have been better with the title “Adopting Pharmacovigilance in Clinical Practice“, as the audience was full of practising doctors for whom ‘Pharmacovigilance’ was not a familiar term. Low audio volume is regretted as it was so in the source. Please use headphones/earphones for better experience. And, do feel free to share this video with your network if you like it! Last but not the least; the month was quite special to me in an individual capacity, as the Pharmacovigilance Special Section of Global Forum, for which DIA chose me as the Special Section Editor, was first published in the December 2021 issue. With the January 2022 issue also out now, I am sure you will benefit a lot by reading the curated articles focused on innovations in Pharmacovigilance and authored by seasoned experts in the subject from many parts of the world. Of course, more is to come in the February 2022 issue as well. I take this occasion to thank DIA editorial team once again for having given this privilege of an opportunity to me. Wishing you all Happy Pongal/Makar Sankranti/Lohri/Uttarayan/Magh Bihu and related festivities, Keen to meet you in our January 2022 newsletter,

Oviya MedSafe – Ten Years of Dedicated Pharmacovigilance January 2022 201 of 328


Dear Well-wishers, Even as I start this January 2022 edition of Oviya MedSafe‘s newsletter (the 112th in the series since April 2012), I am so excited to share with you that Oviya MedSafe is to turn ten soon! The journey of brand Oviya MedSafe which began humbly on 14th March 2012 has evolved to that of a highly successful global expedition over the past decade, thanks to all of your support. We as a team are all set to celebrate our 10th anniversary in a meaningful manner with your heartfelt wishes and seek your encouraging participation as well, for the purpose While wondering how I could briefly emphasize on the essence of what Oviya MedSafe stands for, a forwarded WhatsApp message about the Chinese Bamboo Tree caught my attention with its striking relevance to our organization’s history. Essentially, what it highlighted was that Chinese Bamboo Trees never appeared to grow during their first 5 years of life despite the best botanical care but quickly went on to attain a height of 90 feet during the subsequent 6 weeks. Although a naive spectator could assert that the trees grew rapidly to be 90 feet tall within 6 weeks, the truth was that the trees were never idle and, as the Indian cricket legend Mr Rahul Dravid puts it, were rather strengthening their roots for the first 5 years in order to be prepared for the phenomenal growth that was to follow. Effectively, the 90 feet height was a result of all the cumulative efforts put in throughout the 5 years and 6 weeks period. Oviya MedSafe’s metamorphosis from a then bootstrapped start-up Pharmacovigilance consultancy firm to a now renowned self-sufficient organically developed well-structured multinational organization in the discipline has been no different from the Chinese Bamboo Trees including the timelines, considering the monumental achievements we have to our credit in the past five years. At this juncture, I express my sincere gratitude to everyone who has been part of our journey and contributed to our growth so far. Given our robust pipeline, I am quite sure much bigger accolades are waiting for us in the future. In spite of Oviya MedSafe having a strong reason in hand to organize a fun-filled entertaining event to celebrate this milestone, I am proud to announce that we have decided to continue treading our chosen path of spreading knowledge about Pharmacovigilance instead. Part of this thought stems from the fact that we have often enjoyed the pleasure of giving back to the society and doing so as often as possible only makes us much better professionals in our fields. Further, understanding the fact that the Pharmacovigilance world is literally spread across the globe and that hosting the event virtually would be the most appropriate way to cut across the barriers pertaining to location and logistics, here is what we have planned for the celebration: Topic: “Pharmacovigilance: Of The Pill; For The People“ Presented by: Dr J Vijay Venkatraman & Team Format: Virtual Colloquium on Zoom Platform Date: Friday, 11th March 2022 Time: 4 to 5:30 PM IST (GMT+5:30) 202 of 328


Registration: Free of cost but mandatory (First Come First Serve) Link to register: https://zoom.us/meeting/register/tJErdu6trjwjGNOUCErYaQ6vTdZzqrvN3E-K I look forward to your participation in this colloquium which we as Oviya MedSafe team believe would have pertinent take-home points for every attendee regardless of their level of Pharmacovigilance expertise. Please feel free to share this information with anyone who may be interested. Eager to connect with you through our February 2022 newsletter soon,

Oviya MedSafe – Pharmacovigilance For Everyone February 2022 Dear Well-wishers, I am heartened to meet you through this February 2022 edition of Oviya MedSafe‘s newsletter (the 113th in the series since April 2012), with profuse gratitude to each one of you who expressed your warm wishes in response to our previous edition in which we announced that Oviya MedSafe which was founded on 14th March 2012 was soon to turn ten years old. What a treat it is to realize that we have so many people with so much goodwill for us! Today, I tend to recall why I thought of founding an organization like Oviya MedSafe in the first place. While the passion I developed for Pharmacovigilance thanks to the exposure I had due to my prior employment with the industry is obviously the root cause, I now reflect upon why such a cause took root in me. Ever since I started working in global Pharmacovigilance units in 2007, I had some original thoughts about this field which I wished to express for the betterment of the discipline. However, I came to understand not only that my hypotheses needed to be corroborated by experience but also that my voice would be taken seriously only if I had a demonstrated professional calibre in Pharmacovigilance. And, for that, it needed to be my career too. At this juncture, a natural question would arise: Why was entrepreneurship necessary to make this happen? It was simply because I was much more comfortable in knowingly taking the pain to carve my own path towards my faraway destination with reasonable certainty rather than trying to do my best for the cause without giving up the convenience of taking the conventional road which may have compromised the purpose itself. And, thus Oviya MedSafe was born! Throughout the decade, Oviya MedSafe despite leaving no stone unturned to actively pursue Pharmacovigilance as a business, stood for enhancing the awareness, advocacy, appreciation, adherence and adoption of Pharmacovigilance by all stakeholders. I owe a lot to all of my team members, shareholders, board colleagues, and other interested parties who were so 203 of 328


willing to support the cause that I always believed in that they ended up working hard to take the essence of ‘Drug Safety for Patient Safety‘ to their networks too. Of course, I need to thank Oviya MedSafe’s clients and business collaborators located in different parts of the world for seeing this as an accolade instead of an obstacle. Serendipitously, several honorary leadership positions in many renowned professional associations subsequently came my way and my unbiased performances in those roles made sure the message reached far, wide and deep. As a representative sample, I am glad to share with you the Activity Report of the Indian Medical Association (IMA) Headquarters Standing Committee for Pharmacovigilance of which I was the Chairman for the year 2021. With 5 webinars, 2 published articles, 2 conference talks, 3 stakeholder engagements, 1 recognition (in a World Health Organization publication) and 1 training session, the versatile portfolio of the committee for 2021 is unprecedented, for which I sincerely thank all the distinguished members of the committee and the IMA leadership whose involved support made this to be reality. In fact, these were the thought processes going on in my mind when I named as “Pharmacovigilance: Of The Pill; For The People” the virtual colloquium which we conducted to begin the celebrations of our 10th anniversary. It is with utmost pleasure that I share with you the video recording of the event which was conducted as a Zoom webinar on 11-Mar-2022. Please click on the link https://youtu.be/dveQrSg4HQU to watch this video on our official YouTube channel to which I request you to subscribe with alerts so that you will receive notifications of our future videos as they get posted. As always, feedback is welcome. Before concluding, I once again thank you for all the goodwill and seek your continued encouragement as we move into our second decade of life. Waiting to greet you with our March 2022 newsletter soon,

Oviya MedSafe – Specialized Units for Stronger Pharmacovigilance March - 2022 Dear Well-wishers, I experience an unprecedented sense of achievement when I pen this March 2022 edition of Oviya MedSafe‘s newsletter (the 114th in the series since April 2012); thanks to the positive reviews we received for the virtual colloquium we organized to celebrate the 10th anniversary of Oviya MedSafe’s founding! Although I already expressed my gratitude to all of you for your goodwill for Oviya MedSafe, I wish to once again thank you for your support throughout our journey in Pharmacovigilance over the past decade. It is only such encouragement that motivates us to aim higher and higher. 204 of 328


Today, I wish to speak a little about a unique bouquet of services that Oviya MedSafe has conceived in order to fulfil some business needs in the industry which are not easily addressed by the models currently available in the market. Due to frequent changes in organizational structures, many clients (pharma/biotech/vaccine/medical device companies) nowadays need small but solidly structured Pharmacovigilance teams to be assembled quickly and deputed to their projects albeit for short periods of time. Unlike traditional resourcing engagements that mandate the vendor to only provide adequately qualified and/or experienced people to work on the client’s projects for as long as the client requires, such strategic short-term projects demand a much higher degree of management oversight from the partner organization. Moreover, since the partner is expected to understand the criticality of the project and at times govern the project on behalf of the client (which may include managing other large teams of the client/other service-providers that perform the client’s routine Pharmacovigilance activities), only a Pharmacovigilance-knowledgeable independent third party organization would fit the bill. Having said so, assembling such a talented team of Pharmacovigilance professionals for constituting a specialized unit warrants a wide range of networking capability within the global Pharmacovigilance community. Such an organization should also have enough projects in pipeline in order to be able to assure job security to the new employees, as and when the given client’s project ends. All these aspects are Oviya MedSafe’s strengths which could be leveraged easily for any interested client. Before concluding, I wanted to share with you two brief video messages of felicitation which we received on account of our 10th anniversary. While the first is a testimonial from a former client (Dr Manoj Swaminathan), the other is from a long-time collaborator (Mr Enrico Pedroni) with whom we worked for many Pharmacovigilance knowledge-enhancement initiatives. At this juncture, I wish to thank both of them for their kind words. Of course, more such videos are in the making! Looking forward to connecting with you soon through our April 2022 newsletter,

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Publication in Chinese Language

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Glossary Sl No

Title

Page No:

1

Foreword

2

Brief CV

3

Detailed Professional Profile

1

4

Awards Received from Indian Medical Association

2

5

Medical Text Books Authored/Co-authored

2

6

Interviews

3

7

Papers published in indexed journals

4

8

Publication in Magazines

5

9

Lectures/ Presenting papers/ Chairing Scientific Sessions in State/National/ International Medical Conferences

6

10

Students Classes/ Lectures/ CME/ in Local Academic Forums

20

11

Honorary Positions

21

12

Other Credentials

22

13

Details of Active Social work and in various medical projects

23

14

Monthly Newsletters

24

15

April 2012: Oviya MedSafe – Pharmacovigilance Physician Services

25

16

June 2012: Oviya MedSafe – An Event Partner of „3rd Annual Pharmacovigilance Asia 2012‟

26

17

July 2012: Pharmacovigilance Asia 2012 – Get regulatory updates from 6 countries in just 2 days

27

18

August 2012: Ma Foi Group invests in Oviya MedSafe Pvt Ltd

28

19

September 2012: Meet 60+ Pharmacovigilance Experts on Sep 18 & 19, 2012 at Singapore!

30

20

October 2012: Oviya MedSafe – Your Strategic Pharmacovigilance Partner

31

21

November 2012: First peer-reviewed publication from Oviya MedSafe

33

22

December 2012: Oviya MedSafe – Vision, Mission & Values

33

23

January 2013: Pharmacovigilance Service Offerings from Oviya MedSafe

35

24

February 2013: Invitation to the Launch Event of Oviya MedSafe – Our Pharmacovigilance Company

36

25

February 2013: Pharmacovigilance Workshop by Moin Don at Coimbatore on 23-Feb-2013

37

26

March 2013: Oviya MedSafe – Pharmacovigilance flows from February

38

27

April 2013: Oviya MedSafe – Specialists in Risk Management Planning in Pharmacovigilance

40

28

May 2013: Oviya MedSafe‟s new capabilities & credentials in Pharmacovigilance

42

29

June 2013: Pharmacovigilance Outsourcing & International Clinical Trials Day – Notes from Oviya MedSafe

44

30

July 2013: Oviya MedSafe now offers Pharmacovigilance Support for Indian & Middle East markets too

45

31

August 2013: Oviya MedSafe: Express Pharma, Indian Pharmacovigilance, Medical Device Vigilance and more!

47

32

September 2013: Oviya MedSafe – Bronze Sponsor of 5th Pharmacovigilance Congregation 2013

49

33

October 2013: Pharmacovigilance Services bundled with hosted Drug Safety database solutions from Oviya MedSafe

49

34

November 2013: Oviya MedSafe adds QPPV Services to its Pharmacovigilance Consulting Portfolio

50

35

December 2013: Oviya MedSafe – Advantage Coimbatore, Literature Search & Bangalore Events

52

36

January 2014: Oviya MedSafe – London Exhibition & Indian Pharmacovigilance Updates

53

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37

February 2014: Oviya MedSafe – UK Trip, UAE Visit, LRP Services & Indian Pharmacovigilance

56

38

March 2014: Oviya MedSafe – Second Anniversary, Pharmacovigilance Audits & DIA Conference

58

39

April 2014: Oviya MedSafe inks pact with PV247 Pharmacovigilance Software Database

59

40

May 2014: Oviya MedSafe – Local Literature Search & International Clinical Trials Day

60

41

June 2014: Oviya MedSafe – Expert Clinician Panel & UK Visit

61

42

July 2014: Oviya MedSafe – UK Subsidiary Incorporation, Pharmacovigilance Publication & UK Trip

62

43

August 2014: Oviya MedSafe – Europe Trip, Pharmaphorum Article & PV247 Webinar

63

44

September 2014: Oviya MedSafe – Pharmacovigilance Insights, PV247 Webinar Success & Conference Talks

65

45

October 2014: Oviya MedSafe – DIA Conference, PIPA Publication & Hyderabad Talks

66

46

November 2014: Oviya MedSafe – RoW Pharmacovigilance, PV247 Webinar & Conference Participations

67

47

December 2014: Oviya MedSafe exhibits at DIA Conference in Washington, DC and announces USA expedition

69

48

January 2015: Oviya MedSafe – Revamped Website, USA East Coast Pharmacovigilance Expedition & Mumbai Memories

71

49

February 2015: Oviya MedSafe – PIPA Fellowship, The Wall Street Journal and ISCR Pharmacovigilance Council

72

50

March 2015: Oviya MedSafe – Third Anniversary, US FDA Safety Updates & Indian Pharmacovigilance Developments

73

51

April 2015: Oviya MedSafe – UK bioConclave 2015, Pharmacovigilance in India and the Indian PSUR

75

52

May 2015: Oviya MedSafe – WHO VigiAccess, EU Pharmacovigilance Pearls & Indian Breakthroughs

76

53

June 2015: Oviya MedSafe – Tailored Multi-Regional Pharmacovigilance Support & European Conferences

78

54

July 2015: Oviya MedSafe‟s Pharmacovigilance Event Diary 2015 – London, Mumbai & Singapore

80

55

August 2015: Oviya MedSafe – Pharmacovigilance in Patient Safety Narratives for Clinical Study Reports

81

56

September 2015: Oviya MedSafe – Social Media, Pharmacovigilance & the UK Parliament

83

57

October 2015: Oviya MedSafe – UK South India Business Meet at the UK Parliament & Pharmacovigilance Conferences

85

58

November 2015: Oviya MedSafe – Asian Pharmacovigilance, Indian Emergence & European Compliance

86

59

December 2015: Oviya MedSafe – Bengaluru Pharmacovigilance Workshop & TiE Coimbatore‟s d-Healthcare Event

88

60

January 2016: Oviya MedSafe supports MAHs with pharmacovigilance obligations related to EMA MLM

91

61

February 2016: Oviya MedSafe – XML-E2B Reporting of ICSRs by Industry to Pharmacovigilance Programme of India

92

62

March 2016: Oviya MedSafe – UK FPM Article, Indian Pharmacovigilance Legislation & DIA Speakership

94

63

April 2016:Oviya MedSafe excels in Pharmacovigilance of Patient Support Programmes & Market Research Programmes

96

64

May 2016: Oviya MedSafe – DIA Experience, Article with PvPI & Indian Pharmacovigilance Day 2016

99

65

June 2016: Oviya MedSafe – Brexit, EU Clientele & Indian Pharmacovigilance

100

66

July 2016: Oviya MedSafe – Redefining Leadership in Pharmacovigilance

101

67

August 2016: Oviya MedSafe in Outsourced Pharmacovigilance – Comprehensivising the Compartmentalised

103

68

September 2016: Oviya MedSafe – Viewing Pharmacovigilance as a Value Addition for the Pharmaceutical Industry

105

69

October 2016: Oviya MedSafe – India Pharmacovigilance Support for Local Affiliates of Global Pharma

107

70

November 2016: Oviya MedSafe – Pragmatic Pharmacovigilance Support for US ANDA Holders

109

71

December 2016: Oviya MedSafe fosters Industry-Academia Partnerships for Pharmacovigilance

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72

January 2017: Oviya MedSafe – Building Pharmacovigilance Strategies & Invited Article in DIA Global Forum

112

73

February 2017: Oviya MedSafe – DRUG DILIGENCE 2017 and Honours from DIA & ISPOR

114

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March 2017: Oviya MedSafe – 5 Years in Pharmacovigilance – 60th Newsletter

116

75

April 2017: Oviya MedSafe as an Innovation Strategist in Global Pharmacovigilance

118

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76

May 2017: Oviya MedSafe – Certified MedDRA Coders and Pharmacovigilance Torchbearers

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77

June 2017: Oviya MedSafe and Pharmacovigilance Days – London Experiences & Hyderabad Expectations

121

78

July 2017: Oviya MedSafe – Negotiating the Paradigm Shift in Pharmacovigilance Outsourcing

121

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August 2017: Oviya MedSafe – Enhancing Mentorship in Global Pharmacovigilance

123

80

September 2017: Oviya MedSafe & Indian Pharmacovigilance Guidance for Industry

124

81

October 2017: Oviya MedSafe – Batting for Pharmacovigilance Independence

126

82

November 2017: Oviya MedSafe for PvOIs of Indian MAHs – Pharmacovigilance Training & Certification Workshops

127

83

December 2017: Oviya MedSafe welcomes 2018 – a Year of Hope for Pharmacovigilance

128

84

January 2018: Oviya MedSafe in Pharmacovigilance – Benefiting from an Unconventional Approach

129

85

February 2018: Oviya MedSafe – Personifying Integrity in Pharmacovigilance

130

86

March 2018: Six Years of Oviya MedSafe & 72 Editions of Pharmacovigilance

132

87

April 2018: Oviya MedSafe – Facilitating US FDA Pharmacovigilance Compliance of ANDA Holders

134

88

May 2018: Oviya MedSafe – „IndUS Drug Safety‟ Initiative & Indian Pharmacovigilance Day 2018 Conference

136

89

June 2018: Oviya MedSafe – Augmenting Synergies in Pharmacovigilance

138

90

July 2018: Oviya MedSafe – Exemplifying Versatility in Pharmacovigilance

140

91

August 2018: Oviya MedSafe – Spearheading Advocacy for Translational Pharmacovigilance

142

92

September 2018: Oviya MedSafe – Pioneering Peerless Partnerships with MAHs for Focused Pharmacovigilance

144

93

October 2018: Oviya MedSafe – Cultivating Pharmacovigilance Standards Since 2012

146

94

November 2018: Oviya MedSafe – Epitomizing Pharmacovigilance Entrepreneurship

147

95

December 2018: Oviya MedSafe – Catalyzing Pharmacovigilance Compliance

149

96

January 2019: Oviya MedSafe – Uniting Physicians for Pharmacovigilance

150

97

February 2019: Oviya MedSafe – Patronizing the Pharmacovigilance Pachyderm

153

98

March 2019: Oviya MedSafe – Defining Dignity in Pharmacovigilance

155

99

April 2019: Oviya MedSafe – Regulatory Pursuit Beyond Pharmacovigilance

157

100

May 2019: Oviya MedSafe – Balancing Subject Matter Expertise & Technology in Pharmacovigilance

158

101

June 2019: Oviya MedSafe – Proudly Representing Indian Pharmacovigilance Internationally

160

102

July 2019: Oviya MedSafe – The Origin of Pharmacovigilance Celebrations in India

161

103

August 2019: Oviya MedSafe – Refining Managed Services in Pharmacovigilance

163

104

September 2019: Oviya MedSafe as India‟s Pharmacovigilance Ambassador to America

165

105

October 2019: Oviya MedSafe – Walking with DIA on the Pharmacovigilance road

166

106

November 2019: Oviya MedSafe – Making Pharmacovigilance Lean Since 2012

168

107

December 2019: Oviya MedSafe – Passionately Perpetuating Pharmacovigilance Proficiency

169

108

January-July 2020: Oviya MedSafe in Pharmacovigilance – Soaring above the COVID-19 cloud

170

109

August 2020: Oviya MedSafe – Standing up for Proactive Pharmacovigilance

172

110

September 2020: Oviya MedSafe – Overpowering Brexit-Induced Pharmacovigilance Challenges

174

111

October 2020: Oviya MedSafe – Reminiscing Alongside The Pharmacovigilance River

176

112

November 2020: Oviya MedSafe – Scaling Peaks as a Pharmacovigilance Evangelist

177

113

December 2020: Oviya MedSafe – Maximizing Client Comfort in Pharmacovigilance

179

114

January 2021: Oviya MedSafe in Pharmacovigilance – Constructing Credibility by Communicating Consistently

181

115

February 2021: Oviya MedSafe – Embedding Pharmacovigilance in the Medical Fraternity

183

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116

March 2021: Oviya MedSafe – The Evolution of a Niche Pharmacovigilance Nucleus

185

117

April 2021: Oviya MedSafe – Symbolizing Excellence in Pharmacovigilance

187

118

May 2021: Oviya MedSafe – Scriptwriting Pharmacovigilance and Directing Compliance

189

119

June 2021: Oviya MedSafe –Emanating Holistic Pharmacovigilance Wisdom

190

120

July 2021: Oviya MedSafe – Caring for Pharmacovigilance with Commitment

192

121

August 2021: Oviya MedSafe – Dignifying Pharmacovigilance Globally

194

122

September 2021: Oviya MedSafe – Celebrating Pharmacovigilance with Pride

195

123

October 2021: Oviya MedSafe – Unlocking the Paradise of Pharmacovigilance

197

124

November 2021: Oviya MedSafe – Diligent Pharmacovigilance Support for Clinical Trials

198

125

December 2021: Oviya MedSafe – Earning Respect For Pharmacovigilance

200

126

January 2022: Oviya MedSafe – Ten Years of Dedicated Pharmacovigilance

201

127

February 2022: Oviya MedSafe – Pharmacovigilance For Everyone

203

128

March 2022: Oviya MedSafe – Specialized Units for Stronger Pharmacovigilance

204

129

News

206

130

7th DIA Pharmacovigilance Conference held in Mumbai

207

131

Demand for Pharmacovigilance services rise amidst COVID 19

208

132

India Forming Adverse Event Reporting System

212

133

Oviya MedSafe launches Pharmacovigilance Consulting and Drug Safety services packages for RoW Region

221

134

Benefit-Risk ratio of all drugs should be monitored through pharmacovigilance studies

222

135

IPC and IMA launch CME programme on Pharmacovigilance for Doctors

223

136

Need to assess Drug behavior in population for effective Pharmacovigilance in India

224

137

Oviya MedSafe calls for streamlining Indian PSUR submission & review process

225

138

Oviya MedSafe signs MoU with UK-based company to provide pharmacovigilance support to pharma cos

227

139

Physicians in Coimbatore launch co-offering pharmacovigilance services

228

140

US FDA to involve Indian regulators for inspections to create awareness about its inspection activities in India

229

141

Robust Pharmacovigilance System is a surrogate marker of Quality

230

142

Interview

231

143

Express Pharma

232

144

Keep an eye an Indian Drugs to prevent rare side-effects: Pharmacovigilance expert

238

145

Key to Quality

240

146

New Outsourcing Frontier in India: Monitoring Drug Safety (The Wall Street Journal)

247

147

Articles

252

148

Pharmacovigilance and Risk Management Strategies in Asia 2020

253

149

Gap analysis of some key stakeholders of Indian Pharmacovigilance

256

150

Monitoring Product Safety beyond clinical trials – Industry Practices

258

151

Pharmacovigilance in India: The Past, Present and Future

263

152

Pharmacovigilance Programme of India: SWOT Analysis

269

153

Pharmacovigilance as a value addition for the Pharma Industry

274

154

New Pharmacovigilance Obligations for MAHs in India

278

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155

Incretin-based anti-diabetic therapies: a pharmacovigilance perspective

283

156

Current Status of Pharmacovigilance in India

288

157

The Role of Clinical Pharmacists in Pharmacovigilance: Some thoughts from India

289

158

Pharmacovigilance Outsourcing and Career advantages for Indian Professionals

292

159

Thalidomide Tragedy Revisited

295

160

Social Media as a catalyst in the Advancement of Pharmacovigilance

297

161

Pharmacovigilance – The Perspective

300

162

Pharmacovigilance as an Indispensable Ingredient for India‟s Pharma Growth formula

304

163

Certificate

308

164

DIA

319

165

Publication in Chinese Language

320

166

Speaking at Lords in the UK Parliament

321

167

Dr Vijay‟s abode

322

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