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TOPRA – Provides: Education, Information, Training, Networking, Support

1–3 October 2012 University College Dublin, Ireland Working in cooperation with the Irish Medicines Board

Pharmaceutical Symposium

1–3 October 2012 Human Medicines

Medical Devices Symposium

1–2 October 2012 (2 October only – Stillorgan Park Hotel) Medical Device Regulation in Europe: Now and the Future

Veterinary Medicines Symposium

2–3 October 2012 (Stillorgan Park Hotel) Legislation, Innovation and Rationalisation

SME Day

1 October 2012 Regulatory challenges for and support to SME companies

Official carrier of the 9th TOPRA Annual Symposium 2012


Brochure contents 4–9 Pharmaceutical programme 10–11 Medical Devices programme Dear colleague On behalf of TOPRA and its Working Party for the 9th Annual Symposium, it is my pleasure to welcome all of you to Dublin and of course to the University College Dublin. I would like to thank the Irish Medicines Board (IMB) for their tremendous support for this year’s Symposium which combines the hot topics in regulatory science with the flavour and friendly hospitality of the Emerald Isle. As you will see below the Programme Committee has been drawn from IMB, the EMA, other national competent authorities and industry who have brought together a mix of interesting topics that all Regulatory Affairs Professionals should be following or actively involved in their day to day jobs. We have sessions on procedures that are mature such as scientific advice and centralised procedure which will update you on all the new initiatives in these. We are also going to debate the new clinical trial proposal as well as looking at the implementation of the EU pharmacovigilance legislation a few months after its introduction. In addition we are going to have a very interesting session on debating the new EU medical device legislation which will be joined by our colleagues attending the Medical Device Symposium. Therefore there is a lot happening in the EU Regulatory field today and this is a good chance for you to fully update yourself and be actively involved in the discussions.

This year we have also introduced parallel sessions on other topics of local and operational interest that are run by the IMB and exhibitors and delegates at the Symposium are free to attend them as well. Look out for these as alternative choices to the main sessions where the IMB will cover Compliance with Marketing Authorisations , Developments in Pharmaceutical Quality, Common European Submission Platform (CESP) and Herbal Medicines Regulatory Update. On the networking side we have over 20 exhibitors attending the Symposium exhibiting their tailored regulatory services of interest and on the first evening, we are running a networking drinks reception and a number of interesting stalls displaying local produce as well entertainment that showcases the flavor of Ireland. On the second night after an introduction by a Irish Ministry speaker we have a networking buffet dinner to ensure you can meet with all your colleagues, this will give you an opportunity to meet, discuss and engage with likeminded colleagues on subjects of mutual interest. So it is my pleasure to Chair this year’s Symposium and would like to thank the IMB and everyone involved in the working party and the TOPRA Office for their fantastic support in bringing together this year’s exciting Symposium and encourage you all to be actively involved in the networking and engaging fully in the discussions during the sessions. Craig McCarthy

Alongside these specific regulatory affairs topics we will have be looking at how initiatives on falsified medicines and how these are progressing to eradicate this dangerous international crime. We will also have a session on OTC medicines looking at the latest regulatory trends of moving medicines from prescription to OTC medicines as patents run out on some of the major medicines in the EU. In the availability of medicines we will be debate the lack of access of medicines to patients in the EU and how this can be improved. Finally delivering patient information is very important and we will be looking at the current legislation and how this can be improved to give the patient the best information possible on their medicines. You will also have a chance to hear the IMB give an overview of their current role and activities locally and in the EU and some of the challenges for this vibrant Regulatory agency.

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TOPRA – The Organisation for Professionals in Regulatory Affairs


12–13 Exhibitor profiles 14–15 Conference floorplan 16 Symposium 2013 As upcoming President of TOPRA, it is my great pleasure to welcome you to the 9th TOPRA Annual Symposium in Dublin. I would like to sincerely thank the Irish Medicines Board (IMB) and Craig McCarty and the TOPRA Symposium Working Party for jointly organising this year’s Symposium. As a result of their joint hard work, this symposium will be a truly exciting event. The program includes highly-respected speakers from European Commission, regulatory agencies and industry and covers most relevant hot topics in all aspects of the healthcare regulatory sector. In the stimulating environment of the University College of Dublin, there will be ample opportunity for networking, interaction and debate.

Working Party

With the annual Symposium in Dublin, my Presidency of TOPRA also comes closer. My overall objective will be to ensure that TOPRA continues to excel in supporting the healthcare regulatory profession. If you are interested to hear more about our plans for the upcoming year, you are most welcome to join us at the “TOPRA Annual Review” on Tuesday afternoon at the Symposium.

Angelika Joos, Merck Sharp & Dohme (Europe) Inc, Belgium

I wish you all a great Symposium. Enjoy your time in Dublin and I am looking forward to meeting as many of you as possible during the events. Patrizia Nestby On behalf of the Irish Medicines Board I would like to welcome all delegates to Dublin for what I am confident will be a very informative and rewarding event. I also wish to welcome all our speakers and respective chairpersons and thank them in advance for their contributions over the coming days. My colleagues and I are delighted to have the opportunity to co-host the 2012 Symposium which in its 9th year is now firmly established as one of the principal regulatory events in Europe. From an Irish Medicines Board perspective, the wide-ranging agenda of the Symposium is particularly welcome in that it affords us the opportunity to meet and discuss regulatory developments and updates with professionals from across the key sectors of human and veterinary medicines, and medical devices. There is much to discuss and review across each of these product areas and I am certain that the range of expert contributors and the broad base of the delegates attending will ensure lively and enlightening debate.

Craig McCarthy, CAMPHARM, France (chair) Ann O’Connor, Irish Medicines Board Anthony Humphreys, European Medicines Agency Maria João Morais, Infarmed, Portugal

Margareth Jorvid, LSM Group, Sweden (co-chair) Brenton E James, EU Consultant Eamonn McGowran, Newport Pharma, Ireland (TOPRA-in Ireland) Helene Thybo, Leo Pharma, Denmark Christelle Anquez-Traxler, AESGP, Belgium Alan Hunter, Consultant, UK With input from parallel Symposia chairs: Veterinary Medicines Ray Harding, Independent Consultant, UK Medical Devices Margareth Jorvid, LSM Group, Sweden

We are also very pleased to lend our support to the dedicated SME day which is especially important in assisting life sciences companies with high growth potential to identify and deal with the regulatory challenges they may face.

Anne Tobin, Irish Medicines Board

Finally, I wish to acknowledge the insights and considerable efforts of all those involved in organising this significant event and all those who guided the development of an excellent program which includes contributors from across the European regulatory spectrum.

And support from TOPRA SPIN, Regional and TOPRA-IN groups

I look forward to meeting and chatting with you over the course of the next few days. Pat O’Mahony, Chief Executive, Irish Medicines Board www.topra.org

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The 9th TOPRA Annual Symposium 2012 conference programme

 monday 1 October 2012 12:00

Registration and Exhibition

13.00

Welcome to 2012 Symposium

Ronan Donelan, Head of Regulatory Affairs EMEA & ANZ, Quintiles, Ireland

Lynda Wight, Executive Director, TOPRA

●  Top

Craig McCarthy, Chair of Symposium working party

●  Pitfalls

Pat O’Mahony, Irish Medicines Board (IMB) Chief Executive

SESSION 1 Scientific Advice: an Important Strategic Activity for all Companies Involved in Drug Development Especially SMEs Leader: Craig McCarthy, Managing Director, CAMPHARM, France This session will deal with the new initiatives in scientific advice both Nationally (decentralised) and Centralised (CHMP). The Agency speakers will give their individual views on the advantages of scientific advice as well as outlining the new initiatives introduced into the procedure such as joint advice with HTAs, qualification advice and opinions. The industry speakers will give some top tips for SMEs in gaining their strategic advice and as well as their experiences as an SME on gaining advice from the centralised or National procedures and the importance of this procedure to their drug development program in the EU. There is also a special guest from the FDA that will give her observations on parallel advice after her sabbatical in the EU. Chairperson Craig McCarthy, CAMPHARM, France & TOPRA Symposium Chair 13.30

Introduction – Craig McCarthy

13:35

Update on National Agency Scientific Advice

14:25

●  Reflections

Statistics of scientific advice at the MHRA

13:55

14.35

Parallel EMA/FDA scientific advice

Janice M. Soreth, Deputy Director, FDA Europe Office, Liaison to EMA, USA ●  The

procedure

●  Experience

14.45

so far and advice to users

Questions with this sessions’s speakers

The speakers will take questions from the floor – this is your opportunity to explore the topic more fully. 15.00

Centralised scientific advice

Sheila Killalea, IMB delegate to the SAWP, IMB, Ireland ●  The

procedure and advantages of obtaining centralised scientific advice via the EMA

●  The

new initiatives with scientific advice including joint advice with HTAs and qualification advice/opinion

●  Some

top tips for companies to obtain the best advice from the centralised procedure

●  Statistics

on how things could have been improved from

both sides

new initiative with joint scientific advice with NICE

Some top tips for companies to obtain the best advice from a national procedure

Reflections from an SME Company to National and CHMP scientific advice

a first time experience of an SME of going through both national and CHMP scientific advice processes and how it helped their development strategy

advantages of obtaining national scientific advice from the MHRA perspective

of going through the process

●  Presenting

●  The

●  The

tips on regulatory strategy for SMEs

Richard Jones, Clinical R&D Manager, Cosmo Pharmaceuticals

David Wright, Head of the Scientific Advice Unit, MHRA, UK

4

Top tips on a strategic approach to obtaining scientific advice

14:15

of scientific advice at the EMA

TOPRA – The Organisation for Professionals in Regulatory Affairs

Break


programme Monday 1 October 2012

16:40

SESSION 2 Clinical Trials

Janice M. Soreth, Deputy Director, FDA Europe Office, Liaison to EMA, USA

Leader: Margareth Jorvid, Senior consultant, Methra Uppsala AB/ LSM Group, Sweden Clinical trials are investigations in humans intended to discover or verify the effects of an investigational medicinal product. Requirements for the conduct of clinical trials in the EU are provided in the Clinical Trials Directive 2001/20 EC. Since the implementation of this directive the interpretation and practical use have differed throughout the European member states. The European Commission is planning to put forward, in 2012 a legislative proposal to revise the Clinical Trials Directive. The proposal, its impact and how it influences performing clinical trials in Europe will be discussed in this session. Chairperson Margareth Jorvid, Senior consultant, Methra Uppsala AB/LSM Group, Sweden 15:45

Introduction

15:50

The EU Commission legislative proposal to revise the Clinical Trials Directive 2001/20/EC.

Stefano Soro, Head of unit D6 Medicinal products – quality, safety and efficacy, DG SANCO, European Commission ●  Content ●  Most

of proposal

important changes

●  Follow-up

from the EU Commission

●  Timelines

●  Choice

16:50

17.15

SESSION 3 New EU Medical Device Legislation This session will cover an introduction to the new legislation, the key changes and consequences. Chairperson David Jefferys, TOPRA President and Eisai, UK 17:30

Introduction

17:35

The new regulations and other changes for Medical Device Legislation in Europe

Manfred Kohler, European Commission, Directorate General Health and Consumers, Unit Health Technology and Cosmetics (SANCO B 2)

The Clinical Trials Facilitation Group (CTFG)

work of CTFG

●  Sharing

scientific assessment of multi-national clinical trials

●  Harmonising

processes, practices and assessments of clinical

trials in EU ●  Impact

of the EU Commission legislative proposal

Break

Monday 1 October 2012

● ●

●  The

Panel discussion with this session’s speakers

The speakers will take questions from the floor – this is your opportunity to explore the topic more fully.

Hartmut Kraft, PEI, Germany and Chair of CTFG

of trials/sponsor so far

●  Experience

16:10

Joint EMA/FDA GCP Inspections

A  n introduction to the Revision of the EU Medical Device Directives A  description of the significant changes proposed in the regulations and consequences of these changes O  ther changes proposed A  n outline of the current status in the revision process and the next steps

18:10

Panel discussion with this session’s speakers

The speakers will take questions from the floor – this is your opportunity to explore the topic more fully.

Will the EU Commission Proposal facilitate multinational clinical trials? – a CRO view

16:25

Daphne Smyth, Senior Director Regulatory Affairs EU & Asia-Pacific, ICON Clinical Research, Ireland ●  Experience ●  Changes

of clinical trials in the EU

www.topra.org

5

Programme subject to change

●  Future

of multi-national clinical trials in EU

with the EU Commission proposal


The 9th TOPRA Annual Symposium 2012 conference programme

Monday 1 October 2012 SESSION 4 The role and activities of the Irish Medicines Board This session will cover an introduction to the IMB, its main roles and activities. Chairperson David Jefferys, TOPRA President and Eisai, UK 18:25

Introduction

18:30

The role and activities of the Irish Medicines Board

Pat O’Mahony, Chief Executive, Irish Medicines Board 18:50

Panel discussion with this session’s speakers

The speakers will take questions from the floor – this is your opportunity to explore the topic more fully. Panel includes: Ann O’Connor, Director of Authorisation and Registration, Irish Medicines Board 19:00 20:00

Networking drinks reception in the exhibition hall – a Taste of Ireland Close and free to Explore Dublin

 tuesday 2 October 2012 SESSION 5 Centralised Procedure Leader: Brenton James, EU Consultant Nearly all new chemical entities are approved via the Centralised Procedure in the European Union, and the Committee for Medicinal Products for Human Use [CHMP] plays the key role in scientific assessment of the applications for Marketing Authorisations. The Committee acts in an important role in resolving issues on applications referred from the Decentralised and Mutual Recognition Procedures. In this session the latest information on the Centralised Procedure will be presented and how applications are reviewed by Rapporteurs. Chairperson Brenton James, EU Consultant 9:00

Introduction

9:05

The CHMP

Jens Heisterberg, Chief Medical Officer at the Danish Health and Medicines Authority, Danish CHMP member ●  New

Marketing Applications

●  Arbitration ●  Role

issues

of Scientific Advisory Groups and Peer Reviewers

●  Achievements

9:25

of CHMP in 2012

The EMA

Anthony Humphreys, Head of Regulatory, Procedural and Committee Support, European Medicines Agency ●  Metrics

of Centralised Procedure in 2012 to date

●  Activities

of ORGAM DG (Organisational Matters Drafting

Group) 9:45

The role of a national agency – The IMB

David Lyons, Irish Medicines Board (IMB), CHMP member, Ireland ●  Success

of Ireland as Rapporteurs

●  How

the Irish Medicine Board handles assessment of applications and re-examinations

10:05

Panel discussion with this session’s speakers

The speakers will take questions from the floor – this is your opportunity to explore the topic more fully. 10.30

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TOPRA – The Organisation for Professionals in Regulatory Affairs

Break


programme Tuesday 2 October 2012

Tuesday 2 October 2012

SESSION 6 Self-Care

SESSION 7 Availability of medicines – how to solve the challenges

Leader: Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager, AESGP, Belgium This session will explore the latest developments on self-care in Europe including the recent Commission initiatives on availability and access to non-prescription medicines. The session will paint a broad view of Centralised switches and via MRP-DCP, taking into account the new role of the CMDh and the CMDh Best Practice Guide on self-medication. The reclassification strategy and process will be presented together with tips and advice for companies. A couple of months after the implementation of the new pharmacovigilance legislation, the session will ponder on whether the expected benefits of the legislation have been met in terms of reduction of duplications for both regulatory authorities and companies, savings, increased risk based and proportionate approach which are particular relevant for well-established non-prescription medicines and the many SMEs which constitute the self-care sector sector. Speakers from the IMB, EMA and industry will provide their views. Chairperson Hubertus Cranz, Director General, AESGP 11:15

Introduction

11:20

EMA viewpoint

Zaide Frias, EMA ●  Switch

at central level New legislations (pharmacovigilance legislation and falsified medicines) and central developments – relevance for nonprescription medicines ●  EMA benefit-risk initiative ●

11:40

Industry viewpoint

Glen Carpenter, Vice President, Regulatory Affairs - EMEA Johnson & Johnson, UK ●  Switch/reclassification

strategy ● Opportunities and challenges when switching ●  Current switch environment including Commission’s initiatives ● Impact of the new legislation pieces (pharmacovigilance, falsified medicines, variations, etc.) on a self-care company: more opportunities or challenges? 12:00

IMB viewpoint

Leaders: Ann O’Connor, Director of Authorisation and Registration IMB, Ireland and Helene Thybo, Corporate Regulatory Intelligence Specialist Regulatory Affairs and Safety, Leo Pharma, Denmark When products are either not applied for a marketing authorisation in a member state, not marketed despite a valid marketing authorisation or the marketing is discontinued in a member state, patients are losing the battle of availability of medicines. From the surface the key issue is public health and the equal access to medicines across Europe. However, all parties involved (regulators, industry, patients, physicians etc) are well aware of the complexity of the matter. The same complexity being one of the reasons why this problem is not easily solved. This session will focus on how to solve some of the challenges in the efforts of making medicines equally available to patients across Europe. Chairpersons Ann O’Connor, Director of Authorisation and Registration IMB, Ireland and Helene Thybo, Corporate Regulatory Intelligence Specialist Regulatory Affairs and Safety, Leo Pharma, Denmark 14:00

Introduction

14:05

Availability of Medicines - A Regulator Perspective

Kristin Raudsepp, Director General Ravimiamet (Estonian agency), Estonia ●  Challenges

and current problems so far ●  Possible solutions ●  Progress

Industry Challenges and ideas to improve the availability of medicines

14:25

Pfizer speaker TBA ●  Setting

the scene from industry perspective faced ●  How industry can actively contribute to improving the availability of medicines ●  Challenges

14:45

Initiatives by the European Commission

Peter Bachmann, Chair of CMD(h,)Head of Unit ‘CMDh’, Department of European and International Affairs, Federal Institute for Drugs and Medical Devices (BfArM)

Olive Smyth, Irish Medicines Board (IMB), Ireland

process in Ireland – how does it work? New reclassification initiatives

12:20

Panel discussion with this session’s speakers

The speakers will take questions from the floor – this is your opportunity to explore the topic more fully. 12.45

●  View

15:05

on availability of medicines Panel discussion with this session’s speakers

The speakers will take questions from the floor – this is your opportunity to explore the topic more fully. 15.30

Break

Lunch

www.topra.org

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Programme subject to change

●  Reclassification


The 9th TOPRA Annual Symposium 2012 conference programme

Tuesday 2 October 2012

17:40

SESSION 8 The TOPRA Annual Review

Avril Daly, CEO, Fighting Blindness, European Patient Forum, Ireland

16:05

David Jefferys, Patrizia Nestby and Lynda Wight

Tuesday 2 October 2012 SESSION 9 Falsified medicines Leader: Maria João Morais, Infarmed, Portugal The falsification of medicines and healthcare products is increasing and represents a serious risk to public health across the world, calling for more regulation and global partnerships to combat this phenomenon. The EU has recently adopted new rules applying to medicinal products which will be applicable from 2 January 2013. The new directive imposes tighter manufacturing and distribution rules, safety features, new rules for active pharmaceutical ingredients, controlling exports and online sales. The directive also calls for international partnerships to assist authorities in developing effective strategies to fight falsified medicines thus promoting the implementation of international agreements such as the Council of Europe MEDICRIME Convention and the EU Heads of Medicines Agencies Strategy to 2015. This session will look at these issues along with the outcome of the recent public consultations on safety features and active substances manufacturing requirements. We will also hear about stakeholders’ expectations regarding the implementation of the new rules against falsified medicines and Infarmed’s role in developing collaborative partnerships to fight against counterfeit medicines in third countries. Chairpersons Maria João Morais, Infarmed, Portugal John Lynch, Irish Medicines Board 16:35

Introduction

16:40

The falsified medicines Directive

John Lynch, Director of Compliance, Irish Medicines Board ●  The

falsified medicines directive ●  Future steps 17:00

Falsified Medicines and the Public Health Risk

David Shore, Pfizer Ireland ●

TBA

17:20

The Role of European authorities in the fight against falsified medicines in third countries

Helder Mota Filipe, Infarmed, Portugal ●  International

8

collaborative agreements and strategies

18:00

View of Patient Representative

Panel discussion with this session’s speakers

The speakers will take questions from the floor – this is your opportunity to explore the topic more fully. 18:15

Ministerial Address

Dr James Reilly, TD, Minister for Health, Ireland 18:3021:00

Networking buffet dinner

 Wednesday 3 October 2012 SESSION 10 Patient information in 2020 Leader: Angelika Joos, Head Regulatory Policy EU & Most of World, MSD (Europe) Inc, Belgium Many stakeholders have raised concerns with the usefulness of the current static patient information which has been nearly unchanged for several years. The “information to patients” legal proposal is slowly moving through the EU legislation-making process and will not be adopted in the near future. However, the new Pharmacovigilance Legislation is tasking the European Commission to provide a report on the current product information and its usefulness to stakeholders. This session will cover the expectation of patients related to information on medicines in todays’ environment. It will analyse the feedback and insights gathered through extensive experience with readability testing over the last decade and display the future vision of the pharmaceutical sector how to make this tool more useful. It aims to identify the additional value of a better content and structure and develop a vision for using this important Medical communication tool in todays’ healthcare context. Chairpersons Angelika Joos, Head Regulatory Policy EU & Most of World, MSD (Europe) Inc, Belgium Jan MacDonald, Head, Patient Information Quality, MHRA, UK 8:30

Introduction

8:35

Patient Expectations

Denis Costello, Web Communications Manager, EURODIS (Rare Diseases Europe), Spain ●  Is there

enough information on medicines? do patients get information from? ●  Who do they trust? ●  How useful is the information for their daily life? ●  How important is health literacy? ●  Which role plays social media & Facebook? ●  Where

TOPRA – The Organisation for Professionals in Regulatory Affairs


programme 8:50

The package leaflet is not for the benefit of the patient

10:50

Ann-Margret Tallberg, MSD, representing LIF, Sweden ●  Does the package leaflet meet the patients’ need for information?

do patients perceive the leaflets provided to them? do patients want to have? ●  How can the leaflets be improved? ●  How can information be conveyed using newer technologies?

The new PV legislation - The National Authority Experience to Date

Michael Foy, MHRA, UK

●  How

●  Background

●  What

●  Implementation

9:05

Learnings from academic research and from user testing experience

Theo Raynor, Professor of Pharmacy Practice, School of Healthcare, University of Leeds and Luto Research, UK ●  What

does research tell us about what patients want? ●  What does user testing tell us? ●  How can we successfully include more benefit information? ●  Key issues leading up to 2020 9:20

A Regulator’s perspective on the future needs and introduction to the panel discussion

Jan MacDonald, Head, Patient Information Quality, MHRA, UK 9:30

Panel discussion with this session’s speakers

The speakers will take questions from the floor – this is your opportunity to explore the topic more fully. 10.00

Break

Wednesday 3 October 2012 SESSION 11 The new Pharmacovigilance legislation – The experience after implementation

so far – can the aim of the new PV legislation

be met? ●  Future issues 11:10

The impact of the new PV legislation on industry

Deirdre McCarthy, Director, Customer Delivery Europe, Lifecycle Safety & Infrastructure Management, Quintiles, Dublin, Ireland ●  Rationale

for the changes

●  Overview of the new PV requirements from a company perspective

11:30

Tips for a successful PV inspection and implications of the new PV legislation for future inspections

Sinead Curran, GCP/Pharmacovigilance Inspector, Irish Medicines Board, Ireland ●  Overview

of IMBs national pharmacovigilance inspection program, including the inspection process and examples of common deficiencies ●  A review of the impact of the new pharmacovigilance legislation on the inspection process 11:50

Panel discussion with this session’s speakers

The speakers will take questions from the floor – this is your opportunity to explore the topic more fully. 12.15

Closing remarks by IMB

12.20

Close of Symposium by TOPRA President

12.25

End of Symposium

Leader: Eamonn McGowran, Regulatory Affairs Manager / QP for Pharmacovigilance Newport Pharmaceuticals Limited, Ireland The implementation date of July 2012 for the new PV (pharmacovigilance) Legislation has now passed.  The new legislation replaces Volume 9A of the rules governing medicinal products; with extensive changes and both agencies and pharmaceutical/biotech companies need to be prepared for those changes that have been introduced.  This session will cover the new PV legislation and its impact on both agencies and companies. The Agency speakers will give their individual views on experiences to date.  The industry speakers will give their views on the impact the new legislations is making on business systems and steps to be taken to ensure compliance with legislative requirements Chairperson Joan Gilvarry, IMB, Ireland Introduction

www.topra.org

9

Programme subject to change

10:45


Medical Devices Symposium 2012 Programme monday 1 October 2012  (taking place at UCD) 16:30

Registration and Exhibition

19:00

Networking drinks reception in the exhibition hall – a flavour of Ireland

20:00

Close and free to explore Dublin

SESSION 1 New EU Medical Device Legislation

tuesday 2 October 2012  (taking place at Stillorgan Park Hotel)

This session will cover the Revision of the EU Medical Device Directives. The aim of the session is to give an introduction to the future regulatory framework, outline the key changes proposed in the regulations and consequences of these changes. An outline of where we are currently and the next steps in the revision process will also be given.

08:45

Registration and Exhibition

09:00

Welcome and Introduction to Medical Device Symposium: Margareth Jorvid, co-chair of TOPRA Annual Symposium

Chairperson David Jefferys, TOPRA President and Eisai, UK 17:30

Introduction

17:35

The new Regulations and other changes for Medical Device Legislation in Europe

Manfred Kohler, European Commission, Directorate General Health and Consumers, Unit Health Technology and Cosmetics (SANCO B 2) ●  An introduction to the

Revision of the EU Medical Device Directives ●  A description of the significant changes proposed in the regulations and consequences of these changes ●  Other changes proposed ●  An outline of the current status in the revision process and the next steps. 18:10

Panel discussion

The speakers will take questions from the floor – this is your opportunity to explore the topic more fully.

Tuesday 2 October 2012 SESSION 2 The role and activities of the Irish Medicines Board This session will cover an introduction to the IMB, its main roles and activities. Chairperson David Jefferys, TOPRA President and Eisai, UK 18:25

Introduction

18:30

The role and activities of the Irish Medicines Board

Pat O’Mahony, Chief Executive, Irish Medicines Board ●  A brief

description of the overall responsibilities of IMB and its staffing and structures ●  A more detailed description of IMB Medical Devices activities and ●  The IMB’s practical responses to the Commissioner Dalli Action Plan. 18:50

Panel discussion

The speakers will take questions from the floor – this is your opportunity to explore the topic more fully. Panel includes: Ann O’Connor, Director of Authorisation and Registration, Irish Medicines Board

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SESSION 3 The Medical Device Regulatory System and the impact of the New Legislation This session will provide an insight into the impact that the new medical devices legislation will have on the various groups who are party to the medical device regulatory system. The proposed regulations will introduce changes in the area of notified bodies, clinical evidence and market surveillance. This session will discuss these topics in more detail. Chairperson Ann O’Connor, Director of Authorisation and Registration, Irish Medicines Board (IMB) 09:05

Introduction

09:10

Notified Bodies and the Impact of the New Legislation

Rainer Edelhäuser, ZLG - Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, Chair NBOG, Germany 09:30

Clinical Evaluation and Clinical Investigation - the Impact of the New Legislation

Wolfgang Ecker, Federal Ministry of Health, Chair CIE, Austria 09:50

Market Surveillance and the Impact of the New Legislation

Reinhard Berger, Institut Inspektionen, Medizinprodukte & Haemovigilanz, AGES, Chair COEN, Austria   10:10

Panel Discussion

The speakers will take questions from the floor – this is your opportunity to explore the topic more fully. Panel includes: Manfred Kohler, European Commission, Directorate General Health and Consumers, Unit Health Technology and Cosmetics (SANCO B 2) and Niall MacAleenan, Clinical Assessment Manager Irish Medicines Board 10.30

Break

Tuesday 2 October 2012 SESSION 4 Regulatory Update This session will be a regulatory update on several areas where recent changes have taken place or are on-going. A key session to become up to date on in-vitro diagnostics, medical device software, UDI, traceability, e-labelling and demarcation of medicines and medical devices.

TOPRA – The Organisation for Professionals in Regulatory Affairs


Hilde Viroux, Alcon, Belgium 10:45

Introduction

10:50

In-vitro Diagnostics – new legislation and other updates

Anne Van Nerom, Coordinator for In-vitro diagnostic Medical Devices, Scientific Institute of Public Health, Belgium 11:10

Medical Device Software

Neil Ebenezer, Head of New and Emerging Technologies, Devices Division, MHRA, UK ●  A introduction to medical device software and the regulatory system ●  What

constitutes medical device software on qualification and classification of standalone software – healthcare setting ●  Future activities ●  Guideline

11:30

Unique Device Identifiers, Traceability and E-labelling

Graeme Tunbridge, Head of Medical Devices EU Policy, MHRA, UK ●  A introduction

to UDI and traceability ●  Developments at a European level - joint action plan ●  Developments internationally - IMDRF ●  E-labelling and the Commission regulation 11:50

Demarcation of products as medicines or medical devices

Waldo Weijers, Pharmacist, MEB, the Netherlands ●  Regulatory

framework for medicines and medical devices products ●  Two Worlds? One and the same Patient! ●  Combination

12:10

Panel discussion with this session’s speakers

The speakers will take questions from the floor – this is your opportunity to explore the topic more fully. 12:30

Lunch

Tuesday 2 October 2012 SESSION 5 Vigilance and Risk Management

Risk Management

13:55

Cathal Brennan, Scientific Officer, General Medical devices, Irish Medicines Board ●  Legislative

requirement for risk management medical device lifecycle and risk management ●  Post market surveillance ●  The

Vigilance and Risk Management – Industry view

14:10

Philippe Auclair, Senior Director, Regulatory Strategy and Advocacy , Abbott Quality and Regulatory EMEA, Abbott Vascular International, Belgium Panel discussion with this session’s speakers

14:30

The speakers will take questions from the floor – this is your opportunity to explore the topic more fully. Panel includes: Andrea Hanson, Product manager – Vigilance and Compliance Section, Irish Medicines Board 14:45

Break

Tuesday 2 October 2012 SESSION 6 Access to market This session will cover information on and guidance on taking a medical device from development into the market phase. Speakers will share support available, and experience from working on the European and Worldwide Markets. Chairperson TBA 15:15

Introduction

15:20

Building an internationally competitive medical devices business - The supports from Enterprise Ireland

Brian O’Neill, Manager Lifesciences, Enterprise Ireland ●  How

to take medical device product to the market support companies can receive

●  What

From Implantable Medical  Device Concept to European Market

15:40

James E. Coleman, Chief Executive Officer, Vasorum Limited, Ireland

This session will cover medical device vigilance issues and risk management. The IMB will give an update on vigilance activities from the regulatory point of view, trends, changes going forward, impact of legislative changes. Risk management will then be looked at from a regulatory and industry perspective.

16:00

Chairperson

John Kilmartin, Senior RA Director, Medtronic, Ireland

Niall MacAleenan, Clinical Assessment Manager, Human Products Authorisation and Registration Department, Irish Medicines Board (IMB), Ireland 13:30

Introduction

13:35

The Importance of Vigilance – Competent Authority View

Anne Tobin, Vigilance and Compliance Manager - Medical Devices Human Products Monitoring Department, Irish Medicines Board ●  An

introduction to the legislative requirement ●  IMB – vigilance activity, trends observed ●  Change proposed in the revision to the medical devices directives ●  Impact of Commissioner Dalli Joint action plan

●  How to take medical device product from concept to the market ●  What ●  Key

were the major difficulties regulatory issues

From Ireland into a Worldwide Market – FDA and beyond

●  Challenges

with global development and global market introduction ●  Practical experience of working in the global context 16:20

Panel discussion with this session’s speakers

The speakers will take questions from the floor – this is your opportunity to explore the topic more fully. 16:45

TOPRA in Ireland

Ronan Donelan, Head of Regulatory Affairs EMEA & ANZ, Quintiles, Ireland 16:50

Close of the Medical Devices symposium

www.topra.org

11

Programme subject to change

Chairperson


The 9th TOPRA Annual Symposium 2012 exhibitor profiles 1

Exhibitor TBA

2

The Regulatory Affairs Company – UK

3

Aris Global – Germany

4

Barington James – UK

Exhibitor to be announced Exhibitor to be announced.

5

Liquent – US

The RA Company™ is part of The Clinical Trial Company™ (TCTC), a privately owned full-service clinical research provider. The RA Company™ provides a wide range of regulatory support and believes that our personnel’s firsthand knowledge of the applicable Regulatory Agencies will provide a full and complete service to our Clients. www.theregulatoryaffairs company.com

6

Qumas/Pleasetech – UK

ArisGlobal is a leading provider of integrated software solutions for pharmacovigilance and safety, regulatory affairs, clinical research and medical information. Hundreds of life science companies rely on ArisGlobal’s advanced solutions for maintaining regulatory compliance, workflow automation, improving operational efficiency and easily sharing information around the globe. www.arisglobal.com

7

Tarius – Denmark

Barrington James has 2 dedicated Regulatory Teams spanning the globe, 1 specialising in Drug Development & 1 in Medical Devices. Their  10 year history and extensive network developed over that time has grown their reputation of providing outstanding candidate & client satisfaction and a true consultative approach from their offices in the UK, Europe, Singapore & the USA. www.barringtonjames.com

8

Extedo – Germany

eRegulatory Affairs

LIQUENT provides technology and outsourcing solutions focused around regulatory submission preparation and tasks, dossier planning, eCTD to CTD publishing and registration tracking capabilities. LIQUENT is the premier provider of a scalable, regulatory information management platform and associated regulatory & clinical services that can be leveraged throughout a client organization. www.liquent.com

9

Merrill Brink – Ireland

Merrill Brink International is a leading provider of specialist translation services with tailored solutions for pharmaceutical, biotechnology firms, clinical research organisations (CROs) and regulatory consultants. Merrill Brink is certified to ISO 9001:2008, ISO 27001:2005 and ISO 13485:2003; and registered to EN 15038:2006 and ISO 14971:2007. www.merrillbrink.com

12

QUMAS is the leader in Compliance and Quality Management Solutions for the Life Sciences industry, with more than 260 global customer deployments and domain expertise in regulatory compliance since 1994. www.qumas.com PleaseTech offers unique collaborative document review and authoring solutions, which are used extensively throughout the medical devices industry by medical writing, regulatory, clinical, quality and other departments. www.pleasetech.com

10

Hays Life Sciences – UK

For over 10 years the Regulatory Affairs Recruitment team at Hays Life Sciences have placed Regulatory Affairs professionals within top Pharmaceutical, Biotechnology, Generic, CRO and Consultancy companies on a Global basis. We offer a permanent and interim solutions for a range of Regulatory skill sets at all levels of seniority www.hays.co.uk

Tarius® Web Portals provide easy answers to your global regulatory FAQ’s. Subscribing to your companyspecific Tarius web portal enables direct access to your selection of Human Drugs, Biologics, Medical Device, IVD regulatory information from 75+ countries. It’s “Googlelike”, hassle-free and updated daily. Why not contact us for a free trial? Contact: Eva L. Petersen Email: elp@tarius.com www.tarius.com

11

Real Regulatory – Ireland

Real Regulatory is a team of proven and committed experts in regulatory affairs, providing consultancy and hands on assistance to the pharmaceutical, medical device and related industries. Our team of professionals have many years experience and a wide range of expertise across the spectrum of regulatory affairs activities. www.realregulatory.ie

TOPRA – The Organisation for Professionals in Regulatory Affairs

EXTEDO is the key software and service solutions provider in the field of Regulatory Information Management. The complete EXTEDOsuite covers: Product Registration Planning & Tracking, Submission Management, Pharmacovigilance Management, Labeling Management and Document Management. Today EXTEDO serves more than 700 customers in 57 countries including EMA and more than 25 Regulatory Authorities worldwide. www.extedo.com

12

Octagon – UK

Octagon Research Solutions, Limited is the leader in the electronic transformation of clinical R&D. We offer a suite of regulatory, clinical, process and IT solutions to the life sciences industry. Our integrated suite of offerings is built upon deep domain knowledge, cross-functional eSub expertise, a holistic process approach and integrated solutions. www.octagonresearch.com


exhibitors 13

Dora Wirth – UK

DWL Ltd. is a specialist translation service provider for the pharmaceutical industry with translation solutions in regulatory affairs and clinical & medical research. Celebrating its 50th year, DWL has grown through a dedication and commitment to quality and service. DWL focuses on languages for traditional and emerging markets. www.dwlanguages.com

17

Key People – UK

The Key People Regulatory Affairs Team is one of the most accomplished in the UK & Europe. We have successfully recruited for positions from Regulatory Vice President through to Director, Manager and Associate Levels in Core Regulatory Affairs, Clinical/ non-Clinical & CMC, Labelling, Operations & Publishing. We cover Pharma, Biotech, Generics and OTC sectors. www.keypeople.co.uk

21

Samarind RMS – UK

14

ProClinical – UK

ProClincial work extensively in recruiting both temporary and permanent Regulatory Affairs professionals within the European Pharmaceutical industry. As an established preferred supplier to some of the world’s most prestigious and pioneering companies, ProClinical can help both candidates and hiring managers to achieve their recruitment goals quickly and cost efficiently. Trust – Knowledge – Delivery www.proclinical.co.uk

18

Clinical Trial Consulting (CTC) – UK

15

emedcareers.com – UK

emedcareers.com is the online job website for specialists looking for jobs in the development and marketing of medicines and medical equipment. Search and apply for the latest European based jobs in the pharmaceutical, biotechnology and healthcare industries from leading recruiters and employment agencies. www.emedcareers.com

19

Infotehna – Slovenia

16

CSC – UK

Delivering software and regulatory services to more than 240 clients over 20 years, CSC Life Sciences provides innovative business solutions to the complex challenges facing the global life sciences industry. A full suite of Total Business (TBS) Solutions has been developed to address the industry’s business processes. Visit us at www.csc.com to learn more.

20

SEC Pharma – UK

CTC Clinical Trial Consulting AG is a key provider of flexible resourcing solutions to Pharma/Biotech, Med Devices and CROs. Referred to as the gold standard by our candidates and clients, we have a strong track record of engaging and placing the very best talent in Clinical, pre-Clinical, Safety, and Regulatory/Med Affairs roles. www.ctcon.ch

INFOTEHNA Group is a market leader in the development and delivery of integrated enterprise content management solutions (ECMS) for Life Sciences industry. INFOTEHNA’s integral by designTM set of solutions myPharmaExpert SuiteTM effectively address industry-specific challenges in the fields of Regulatory Affairs, Quality Assurance & Quality Control, Research & Development and Pharmacovigilance. www.infotehna.com

SEC Pharma support Pharmaceutical, CRO and Biotech organisations throughout Europe, focusing on recruitment across Regulatory Affairs, Clinical Research, Biometrics, Medical Affairs and Pharmacovigilance. Our dedicated Regulatory Affairs team provide a consultative service, catering for the individual needs of every client and advising and preparing candidates in line with the continual changes of the Regulatory Affairs marketplace. www.secpharma.com

22

23

24

Thomson Reuters – US

Lorenz – UK

Nextdocs – US

RMS samarind regulatory management software Samarind RMS is an innovative regulatory tracking database with integrated xEVMPD, eCTD and EDMS tools. Users in over 100 countries agree that the system is quick to learn and easy to use, with superbly flexible reporting facilities and excellent security. And Samarind is a great company to work with. www.samarindrms.com

Thomson Reuters Life Sciences supports R&D productivity across the Pharma lifecycle with respected and comprehensive intelligence solutions. Offering unbiased scientific, competitive, regulatory, and generics information, analytics, and expertise for your organization, Thomson Reuters Life Sciences empowers and enables effective, evidence-based decision-making at every stage from discovery to launch and beyond.  www.science.thomson reuters.com/pharma

LORENZ is the most established provider of e-regulatory software and services in the world. LORENZ has focused on bringing intuitive, business-driven solutions to the market. As an innovative software engineering company, LORENZ’ solutions foster independence, empowering customers to develop their processes and maintain control of their own intellectual property. www.lorenz.cc

NextDocs is the global leader in providing Microsoft SharePointbased compliance and quality management solutions to life sciences organizations. It enables businesses in regulated industries to achieve compliance with FDA, EMA and other agencies while automating processes, improving efficiency and dramatically reducing costs. www.nextdocs.com

www.topra.org

13


The 9th TOPRA Annual Symposium 2012 conference floorplan

Registration area Access to Robing Room for SME Day and Parallel Sessions

1

2

20

3

21

19

4

22

23

5

6

■ IMB ■ TOPRA ■ Four Pillars ■ Cranfield ■ Cogent

7

24

8

Catering station

Catering station

Exhibition area 17

16

15

14

13

12

11

10

Conservatory

9

18

Catering station

Flow of traffic 14

TOPRA – The Organisation for Professionals in Regulatory Affairs

Plan not to scale

Scientific sessions


floorplan Exhibitors Stand

Company

1

Exhibitor TBA

2

The Regulatory Affairs Company

3

Aris Global

4

Barrington James

5

Liquent

6

Qumas/Pleasetech

7

Tarius

8

Extedo

9

Merrill Brink

10

Hays Life Sciences

11

Real Regulatory

12

Octagon

13

Dora Wirth

14

ProClinical

15

emedcareers.com

16

CSC

17

Key People

18

CTC

19

Infotehna

20

SEC Pharma

21

Samarind RMS

22

Thomson Reuters

23

Lorenz

24

Nextdocs www.topra.org

15


The 10th TOPRA Annual

Symposium 2013 Lisbon, Portugal TOPRA – The Organisation for Professionals in Regulatory Affairs

Pharmaceutical Symposium Medical Devices Symposium Veterinary Symposium

October 2013 Organized In conjunction with INFARMED – National Authority of Medicines and Health Products, I.P, Portugal More information, visit www.topra.org/symposium2013


Symposium brochure