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Professional Development for the Therapeutics Ind

FULL PROGRAM

Information Booklet

2 11 ARCS

Regulatory, Quality and Pharmacovigilance Congress

15 – 16 September, Canberra


2 11 ARCS

Regulatory, Quality and Pharmacovigilance Congress

™®

15 – 16 September, Canberra

ofessional Development for the Therapeutics Industry ™

15 – 16 September, Canberra

Table of contents

Acknowledgments

Day 1: Thursday 15 September 2011

ARCS would like to thank all those who contribute to Congress –Interest Area Convenors, Interest Area Committee members, speakers, session chairs, delegates, exhibitors and sponsors. Each plays a major role in bringing Congress to reality. Special and sincere thanks must go to the Conference Committee who oversees the development of the program with the support of the ARCS Business

Opening Plenary: ANZTPA and other therapeutic goods

Office staff and representatives of the ARCS Board.

Introduction .............................................................................................2 Keynote speakers.....................................................................................3-4 Program Overview....................................................................................5

regulation developments (T1) 9.30am – 10:30am....................................6 Concurrent Sessions (T2 – T5) 1.30pm – 3:00pm...................................6-7 Concurrent Sessions (T6 – T9) 3.30pm – 4.00pm....................................7-8 Day 2: Friday 16 September 2011 Opening Plenary: (F1) 8.30am – 10:00am.................................................9 Concurrent Sessions (F2 – F5) 10.30am – 12.00pm................................9-10 Concurrent Sessions (F6 – F13) 1.00pm – 2.30pm.................................10-11 Concurrent Sessions (F9 – F12) 3.00pm – 4.30pm.................................12-13 Registration Information............................................................................15 General Information..................................................................................16

CONFERENCE COMMITTEE MEMBERS Nicola Powell Sharon Butt Rosalie Cull Julia Guinan Ailsa Surman John Leach Trevor Schoerie ARCS BOARD Rosalie Cull Ailsa Surman Trevor Schoerie

Business Partners and Sponsors..............................................................16 ARCS STAFF Joseph Badolato George Azoury Elizabeth Quinn-Joya Berta Brein Jinny Nagi Bridget Lynch Adrian Bootes

Social Program Date:

September 15, 2011

Time:

7:30PM-11PM

Venue:

The Ballroom, National Convention Centre Canberra

Cost:

Included in all registrations

Details:

The conference dinner theme this year is ‘Carnival’ and will be ... held in the Ballroom at the National Convention Centre Canberra from 7:30PM-11PM. There will be games and prizes to be won along with some fantastic entertainment. This evening is sure to be the highlight of the ARCS social calendar!

Entrance to the dinner will only be possible if your name badge reflects that you have said YES to the dinner in your registration. (Please contact Elizabeth Quinn-Joya at the registration desk if you are registered to attend the dinner but can on longer attend)

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ARCS 22 11 11 ARCS

Regulatory, Quality and Pharmacovigilance Congress Scientific Congress

™®

15 – 16 September, Canberra 15 –Royal 16 September, 26 – 27 May, Randwick,Canberra Sydney

rofessional Development for the Therapeutics Industry ™

WELCOME WELCOME New Frontiers in Therapeutic Development and

KEY DATES KEY DATES11 July 2011 Registrations open

Regulatory, Quality and Pharmacovigilance Usage Congress 15-16 September 2011

Registrations Open 16 March 2011 Extra Earlybird discount closes 1 2 August 2011 Extra Earlybird Discount April2011 2011 Earlybird discount closes Closes 2618August

On behalf of the ARCS Conference Committee, On behalf of the ARCS Conference Committee, the the ARCS Board and the ARCS Business Office, I ARCS Board and the ARCS Business Office , I invite you invite you and bid you welcome to one of the and bid you welcome to our innovative regulatory, quality foremost conferences for therapeutic development and pharmacovigilance congress for 2011 at the Canberra in Australia. 2011 sees us facilitating a very Convention Centre. In additional to our traditional strong comprehensive programme, with 90 speakers regulatory programme, this year we have some significant confirmed or invited for up to five concurrent innovations sessions for the two conference days. This year, • A focus on ANZTPA, the vision next stepsOffice for the the Conference Committee andand Business transition and what you as industry want from this have broadened our horizons with streams of • Update multiple Affairs TGA reforms announced or pending content foronMedical and Study Coordinators, as• well as Clinical A strong devices Research programme (Australia and Asia), Pharmacovigilance, Medical Writing, Biostatistics, • A full GMP/quality programme Management and general Business Skills.

2 May2011 2011 26 August close NoRegistrations cancellations after 9 September 3 May2011 2011 Congress 15-16 September Normal Registration Closes 21 May2011 2011 Exhibition hours Congress 26–278.30am May– 6.00pm 2011 Thursday 15 September 2011 Earlybird Discountafter Closes No cancellations

Exhibition Hours 2011 Friday 16 September Thursday 26 May 2011 Networking Friday 27 May function 2011 Thursday 15 September 2011 Networking Function Open trade afternoon Thursday 26 May 2011 FridayTrade 16 September 2011 Open Afternoon Friday 27 May 2011

and some of our speakers as follows:

We are pleased to welcome international and local • Dr Stewart speakers fromJessamine, industry, Group Manager, Medsafe, NZ government, academia and hospitals, including medical key opinion leaders, • Dr Rohan Hammett, National Manager, TGA state (VIC, QLD, NSW) and federal health depts • Tor Graberg, Chief Pharmaceutical Inspector, Medical and consultants from (TGA), as well as specialists Products Agency, Sweden and Global Head PIC/S the Pharma industry. The ARCS congresses offer all • Michael Arnold, Global Business Process Head, Pfizer of our speakers and participants a neutral forum for ARCS, as a not-for-profit development organisation is the exchange of information to foster our charged with up skilling its members in current and new professional development.

8.00am – 3.30pm

7:30am – 7.00pm 7.30am – 3.30pm 5.00pm – 6.00pm

6.00pm – 7.00pm 2.30pm – 3.00pm

1.30pm – 3.00pm

REGISTRATION FEES COB 12 August COB 26 August COB 9 Sept Extra-EarlyBird EarlyBird Registration

information and processes to equip you to be successful.

We also have a great conference dinner planned, Overall we have more than 80 speakers and chairs over adjacent to the racecourse planned for networking 22 sessions.We hope that you take advantage of these with friends and colleagues (included in the 1 and 2 sessions and learning opportunities. day registration prices and $95 for other members On may behalfwish of the Conference Committee and ARCS who to join us).

Member 2 Day $935 $985 $1085 1 Day $645 $685 $755 Student or Retired Member 2 Day $635 $695 $795 1 Day $445 $495 $565 † Non-Member 2 Day $1195 $1245 $1365 1 Day $905 $945 $1035 Government or Academic Employee†* 2 Day $635 $695 $795 1 Day $445 $495 $565 TGA – by arrangement with ARCS

I also wish to invite you to the conference dinner on

Don’t miss thisevening opportunity to meet, itdiscuss, exchange the Thursday 15 September, should be very and learn from our partners and each other. ideas entertaining! I also encourage you to register early and take We look forward to seeing you and thank you for advantage of the great early bird conference rates. attending.

We look forward to seeing you on 26-27th May. Adrian Bootes ARCS CEO. Adrian Bootes ARCS CEO

10-14 Sept Late Registration

$1320 $925 $1030 $745 $1615 $1215 $1030 $745

Price includes ARCS membership. * Members and non-members employed in their primary role by a Government or Academic organisation are eligible for this rate. †

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2 11 ARCS

Regulatory, Quality and Pharmacovigilance Congress

™®

15 – 16 September, Canberra

rofessional Development for the Therapeutics Industry ™

15 – 16 September, Canberra

Speakers

Here is a selection of the over 80 speakers and chairs at the conference Michael Arnold, Business Process Head, Pfizer Currently the Business Process Head for Pfizer’s Global Clinical Supply Chain. Michael has worked in the pharmaceutical industry for the past 25 years, all of which have been at Pfizer. His responsibilities have included directing clinical supply warehousing, packaging, labeling and distribution, comparative agent manufacturing, writing INDs, establishing an import/export process, designing, validating and implementing new computer systems, establishing Pfizer’s initial contract packaging and manufacturing processes and most recently, business process modeling and continuous process improvement. Michael is actively involved in a number of professional organizations. He is a past chair of the Investigational Materials Discussion Group (IMDG) and is currently an active Member of the ISPE IP COP North America Steering Committee. Carol Bennett, Executive Director, Consumer Health Forum Carol Bennett was appointed Executive Director of the Consumer Health Forum of Australia – the peak organisation for health consumers in Australia - in early 2009. In this time, she has been responsible for the development of policy on key health issues including consumer participation in health reform, e-health, pathology services, medical technology, medicines policy, diagnostic imaging and the Medical Benefits Schedule. Ms Bennett has worked at the executive level in health organisations for the last fifteen years, including as CEO of peak national and state health bodies, and major consultancy roles with organisations including Beyondblue. Ms Bennett is a passionate advocate for consumer involvement to drive better decision making in health policy development and better health outcomes for consumers. She has pressed e-health as a key enabler for a more effective, safer and responsive health system. Ms Bennett and CHF are providing consumer leadership in this area, stimulating debate and working proactively with stakeholders to look at how this work can be progressed by building the essential element of consumer confidence. A Masters Graduate in Public Policy from the Australian National University, Carol is committed to the role of non government organisations as drivers of improved health outcomes for their communities.

David Edmonds, Chair RACI and Principal CMC Regulatory Presently Principal of CMC Regulatory, commences February 2008. CMC Regulatory advises to therapeutic goods R&D companies and manufacturers regards to the Regulatory and GMP/auditing requirements. Previously Manager, Quality Assurance and Regulatory Affairs at Peptech Limited (now Arana Therapeutics Limited) for over 20 years and David has held QA, Manufacturing and Laboratory management positions at Lilly Industries, A.H. Robins Pty Ltd, Lilly Industries and Sterling Pharmaceuticals during the previous 20 years. Voluntary Committees involving therapeutic goods include membership/Chair of RACI Pharmaceutical Science Group (NSW) 1987-present, Associate member Pharmacopoeial Sub-committee of the Joint Interim Expert Advisory Committee on Standards 2005 - 2007. Michael Flood, Principal, Locus Consulting Michael began his career in medical devices in the late seventies with qualifications in Engineering. Through his career he has seen all sides of the medical devices industry, commencing with a number of years in technical management and marketing for an Australian manufacturer, nearly ten years with a State Health Department Biomedical Engineering Unit, and more recently with the Therapeutic Goods Administration. Having left the TGA in mid 2010, he has established a consultancy practice in Australia - Locus Consulting, specializing in regulatory affairs, international regulatory training for economies introducing devices regulations, health technology assessment and biomedical engineering. Dr Rohan Hammett, National Manager of the Therapeutic Goods Administration (TGA). Prior to his appointment as National Manager, Dr Hammett was the Principal Medical Adviser at the TGA. Dr Hammett is a Consultant Physician in Gastroenterology and is an adjunct Associate Professor of Medicine at the Australian National University. Before joining the TGA in 2005, Dr Hammett performed senior clinical and management roles within the New South Wales health system and was the Director of Healthcare Improvement Projects at the NSW Clinical Excellence Commission.

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Dr Hammett has been Chair of the National Drugs and Poisons Schedule Committee and is the current Chair of the National Coordinating Committee for Therapeutic Goods. He is a founding member of Australia’s National Medicines Policy Executive Committee. He is a member of the Steering Committee of the Global Harmonisation Taskforce for Medical Devices and the CIOMS working group on Signal Detection in Pharmacovigilance. Dr Hammett chairs the curriculum advisory committee at the School of Pharmaceutical Sciences at Royal Melbourne Institute of Technology. Since taking on the role as National Manager at TGA, Dr Hammett has moved to increase transparency, accountability and efficiency at TGA and has led the introduction of several pieces of legislation to the Australian parliament over the past 18 months delivering significant and longawaited regulatory reforms. He has also driven significant improvements in business processes within the TGA which have improved timely access to therapeutics for the Australian people. Dr Hammett is married to a tireless, patient and long-suffering Respiratory Physician, and has 5 wonderful children ranging in age from 5 to 14. Tor Graberg, Chief Pharmaceutical Inspector, Head of Drug Inspectorate, Medical Products Agency , Global Head of PIC/S Mr. Gråberg has been with the Medical Products Agency since 1996 as a Pharmaceutical Inspector with a focus on manufacturing of medicinal products both national and international. In 2004 he was appointed as Head of Drug Inspectorate. Before joining the MPA Mr. Gråberg was working as a production manager during 13 years in the pharmaceutical industry. He holds a M.Sc. degree in Pharmacy from the University of Uppsala, Faculty of Pharmacy. Mr Gråberg is the Swedish delegate at EMA GMDP Inspectors Working Group since 2004. Since January 2010 he is the Chairman of PIC/S (Pharmaceutical Inspection Co-operation Scheme). Since April 2011 he is a member of PDA Science Advisory Board.


2 11 ARCS

Regulatory, Quality and Pharmacovigilance Congress

™®

15 – 16 September, Canberra

rofessional Development for the Therapeutics Industry ™

15 – 16 September, Canberra

Speakers Dr. Stewart Jessamine, Group Manager, Medsafe Born and raised in Scotland, Stewart graduated from Glasgow University in 1981 and completed his training in General Practise before emmigrating to New Zealand in 1987. After working as a rural GP for 6 years he joined the medicines regulatory authority of New Zealand (Medsafe) in 1993. Stewart’s career has taken him from clinical advisor to Group Manager of Medsafe. His experience in clinical trials regulation, medicines evaluation, clinical risk management, legislation development and harmonisation with the Australian regulatory system has provided Stewart with a unique perspective on the regulation of therapeutic products. Stewart is an articulate advocate of pragmatic risk management. His expertise and presentational style always make his work challenging, honest, direct and thought provoking. Dr. Jamie McGinness, Head, Clinical Evaluation Section 4, Office of Medicines Authorisation, TGA Dr. Mark McDonald, Head, Office of Scientific Evaluation, TGA Dr. Harry Rothenfluh, Head, Office of Medicines Authorisation, TGA Shelley Tang - Principal, Stellar Consulting Pty Ltd Ms Tang was formerly Head of the Office of Devices Authorisation at Australia’s Therapeutic Goods Administration. She holds a Bachelor of Applied Science, in Medical Technology, majoring in microbiology and histopathology. Ms Tang has 14 years’ experience in pathology laboratories, working in the fields of histopathology, haematology, blood banking and microbiology. In her time at the TGA, she spent 11 years with the Microbiology Section of TGA Laboratories, specialising in assessment of sterile manufacture of medicines and devices, one year as head of the Biomaterials and Engineering Section of TGA Laboratories, managing the program of testing of medical devices and supervising the Medical Device Incident Reporting and Investigation Scheme, and ten years as Head of the Medical Device Assessment Section, responsible for the program of

conformity assessment for medical devices, including assessment done under Australia’s Mutual Recognition Agreement with Europe and the Memorandum of Understanding with Canada. She also led the development of the technical requirements for Australia’s new IVD regulatory scheme, introduced on 1 July 2010. Ms Tang was a member and then Chair of the Global Harmonisation Task Force Study Group 1 sub-group on IVDs, and a member of the International Standards Organisation Technical Committee 212, developing standards for IVDs. She currently runs her own company, Stellar Consulting, providing consulting services both nationally and internationally on the regulation of medical devices, including IVDs. She is currently working with WHO to develop regulatory systems for IVDs in Tanzania and South Africa. Bob Tribe, WHO Expert Committee Member, ISPE, Executive Consultant, PharmOut & Owner, Bob Tribe Consulting With over three decades of pharmaceutical regulatory compliance experience, Bob Tribe is regarded as a true expert in the field. As Chief GMP Auditor at the Australian TGA for twenty four years, Bob had a hand in creating many of the GMP requirements now in place. He now consults to manufacturers on complying with them. Bob also consults to many GMP regulators around the world, assisting them reach the PIC/S level of regulatory control. He has assisted the Health authorities of South Africa, Israel, Ukraine and Cyprus obtain PIC/S membership, and is currently assisting other Health authorities reach the same goal. He works frequently in developing countries, supporting their efforts to establish safe and compliant pharmaceutical manufacturing facilities. While at the TGA, Bob’s expertise was recognized by his appointment to Deputy Chairman of the PIC/S during 1998-1999. This was followed by a tenure as Chairman of PIC/S from 2000-2001. Bob is currently a member of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and was appointed Rapporteur for the Committee in 2001 and 2004. He also participates in the WHO Prequalification Program by participating in WHO GMP inspections of manufacturers of medicinal products used for HIV/AIDS, malaria, tuberculosis and for reproductive health.

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Bob also holds the position of AsiaPacific Regulatory Affairs Advisor with the International Society of Pharmaceutical Engineering (ISPE) and is an Executive Consultant with PharmOut Pty Ltd Dr. Susan Walters, Ad hoc consultant for WHO, the Global Fund and other international organizations. Susan is a pharmacist with a PhD in pharmaceutical chemistry. She grew up in the United Kingdom and migrated to Australia after graduation where she worked with the then Burroughs Wellcome Pty Ltd in Sydney. The majority of her career was spent with the Australian Therapeutic Goods Administration in the premarket evaluation of quality aspects of prescription medicines. After retirement from TGA, Susan began a new career in convening and teaching the pharmaceutical development of medicines in a postgraduate course in Pharmaceutical Medicine and Drug Development with the University of New South Wales. But always close to her heart has been her connection with the World Health Organization. She greatly values the opportunities she has had to help with training courses for regulators in less well developed countries, and preparation of guidelines concerning medicines. Her proudest achievement is her part in drafting WHO’s Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) products - a Manual for a Drug Regulatory Authority. After an initial distribution to the Regulatory Authorities of member nations, more than three thousand additional copies were distributed in response to requests. The manual became known as the Blue Book. It has become the basis of guidelines issued by the WHO Prequalification Programme for medicines used in the treatment of HIV/ AIDS, tuberculosis and malaria. An update, also authored by Susan, will soon be published. She drafted the current policy for quality assurance of medicines procured by partners in The Global Fund to Fight AIDS, Tuberculosis and Malaria. Partners include MSF, UNICEF, UNITAID, USAID, the Gates and Clinton foundations, the World Bank and others. She has appointments as Associate Professor at the universities of NSW and Canberra


2 11 ARCS

Regulatory, Quality and Pharmacovigilance Congress

™®

15 – 16 September, Canberra

Professional Development for the Therapeutics Industry ™

Programme Overview 8:30 – 9:30 9:30 – 10:30 T1

Registration, Welcome Coffee & Trade Exhibition Opening of ARCS Congress

Day 1 Thursday 15 September 2011

ANZTPA and other Therapeutic Goods Regulation developments

10:30 – 11:00 11:00 – 12:00 T1

15 – 16 September, Canberra

Morning Tea & Trade Exhibition T1 continued

ANZTPA and other Therapeutic Goods Regulation developments (continued)

12:00 – 1:30 1:30 – 3:00 T2 ■

Lunch & Trade Exhibition Concurrent sessions

GMP Audits in Asia, golbal trends, trials and tribulations  

T3 ■

Medicines, Medical Devices, IVDs – the evolving world of combination products 

T4 ■

TGA Regulatory reforms

T5 ■

IVD Regulation after 12 Months and what the future holds  

3:00 – 3:30 3:30 – 5:00

Afternoon Tea & Trade Exhibition Concurrent sessions

T6 ■

PIC/S and Quality Risk Management

T7 ■

The Orphan Drug Program in Australia; experiences to date and where to next

T8 ■

Clinical Evidence and expectations for all risk classifications for Medical Devices and Procedure Packs 

T9 ■

Packaging changes in New Zealand

5:00 – 6.00 6:00 – 11:00

Pre-Dinner Drinks & Trade Exhibition Conference Gala Dinner

8:00 – 8:30 8:30 – 10:00

Registration, Welcome Coffee & Trade Exhibition Day 2 Opening Plenary

F1

Day 2 Friday 16 September 2011

The importance of PIC/S as a global coordinator in the development of regulatory guidelines 

10:00 – 10:30 10:30 – 12:00

Morning Tea & Trade Exhibition Concurrent sessions

F2 ■

Information quality integrity and validation

F3 ■

Labelling and packaging 

F4 ■

Social Media 

F5 ■

Bringing products to market with less panic and minimal ad hoc decisions

12:00 – 1:00 1:00 – 2:30

Lunch & Trade Exhibition Concurrent sessions

F6 ■

Requirements and responsibilities for industry, associated with release of the 17th edition of the Australian Regulatory Guidelines

F7 ■

Update on the Biologicals Framework

F8 ■

Publishing electronic submissions from an eCTD and Nees perspective – it’s not all magic

F13 ■

Biosimilars – why are there special regulatory requirements?

2:30 – 3:00 3:00 – 4:30

Afternoon Tea & Trade Exhibition Concurrent sessions

F9 ■

TGA on – site GMP audit of an overseas manufacturing site – what does it mean for an Australian regulatory affairs department

F10 ■

Quality Module 3 and beyond

F11 ■

The Regulatory Super Sleuth

F12 ■

RMP implications for Prescription Medicine Registrations

DISCLAIMER: Some speakers and topics will be changed as it is finalised. ARCS Australia reserves the right to change the program and contents as necessary.

■ GMP Quality

■ Prescriptions

■ Devices/Biologicals/OTCs

■ Pharmacovigilance

■ In Vitro Diagnostics


2 11 ARCS

Day 1 Thursday 15 September 2011

Regulatory, Quality and Pharmacovigilance Congress

15 16 September, Canberra Time–& Session Information

8:30 - 9:30am 9:30 – 10:30 am

Speaker Information

Registration, Welcome Coffee & Trade Exhibition Opening Plenary:

T1 ANZTPA and other therapeutic goods regulation developments

Dr. Rohan Hammett National Manager,

Synopsis: Dr Rohan Hammett, National Manager of the Therapeutic Goods Administration and Dr. Stewart Jessamine Group Manager, Corporate, Medsafe will provide an overview of the staged development of the Australian and New Zealand Trans-Tasman regulatory agency. Other recent and imminent Medsafe and TGA changes, reviews and reforms will also be discussed. Steve McCutcheon, CEO of Food Standards Australia and New Zealand will provide a perspective and lessons learned for stakeholders from an authority that has already succeeded in the trans-tasman harmonisation process.

10:30 -11:00 am 11:00- 12:00 pm

TGA

Dr. Stewart Jessamine Group Manager

Corporate, Medsafe

Steve McCutcheon CEO, Food Standards Australia New Zealand Adrian Bootes CEO, ARCS Australia Session chair: Adrian Bootes CEO, ARCS

Morning Tea Opening Plenary continiued

T1 ANZTPA and other therapeutic goods regulation developments (continued)

12:00 -1:30pm 1:30 - 3:00pm

Lunch & Trade Exhibition Concurrent Sessions

Anton Norder Auditor, Office of Manufacturing Quality, TGA

T2 GMP audits in Asia, global trends, trials and tribulations Synopsis: Adherence to Good Manufacturing Practice (GMP) is vital as active pharmaceutical ingredients (APIs) compliance with monograph requirements or finished product compliance with specifications alone is not sufficient to ensure adequate product quality. Reliance on testing of products will verify and detect only tested product attributes, and is unacceptable as the only measure to affirm quality of medicines. Moreover, no amount of testing will prevent fraud, only may detect fraud. More and more APIs and medicines are supplied to the world from manufacturing facilities in India, China and other Asian countries. It is predicted that by the year 2012 India alone will supply to the World close to 80% of generic medicines.

Robert Prestridge Auditor, Office of Manufacturing Quality, TGA

Andrzej Wozniak Director, Executive

Consultant, Quality GMP Consulting Pty Ltd

Session Chair: Andrzej Wozniak

Director, Executive Consultant, Quality GMP Consulting

This and the growing counterfeit problem pose a big challenge to industry and consumers. In response to that challenge, regulatory authorities such as USFDA, EMA and TGA have been expanding their programs to assure that APIs and medicines are manufactured in compliance with GMP and that appropriate controls and traceability safeguard the international supply chain. Some of the initiative involve joint inspection/audit programs or increased sharing of information on manufacturers in Asia. USFDA decided to have a physical presence in India and China. Good Distribution Practice inspectors/auditors are being trained to verify supply chain integrity and prevent fraud. New technology is being developed and some already implemented by manufacturers to protect their products from counterfeiting. Increased number and more thorough regulatory and third party inspections/audits of manufacturers and suppliers seem to be a good way of providing assurance that product are being manufactured in compliance with GMP. However, there are several difficulties when conducting inspections/audits in Asia, starting from having a fluent (and trusted) translator through dealing with slowing audit tactics used by the manufacturers to manufacturers not being honest with the auditor. Several examples of those will be provided as well as some hints on how to handle these difficult audit situations. T3 Medicines, Medical Devices, IVD’s – The evolving world of combination products Synopsis: This session will relate the evolving regulatory frameworks for these combination products. The main discussion points will be around the challenges faced by manufacturers, sponsors and the TGA in the post market arena for these types of products in Australia. Learning Objectives: The session will explore the postmarket regulatory questions posed of the industry and the regulator for combination products, from both a medicines and medical devices perspective. It will consist of three short presentations offering both industry and TGA experiences on the issue, to inform the audience, and then an open discussion/workshop forum for both the panel and participants will follow. T4 TGA Regulatory Reforms Synopsis: Dr Harry Rothenfluh will provide an update on the TGA’s Business Process Reforms (BPR) for prescription medicines, and also an overview of the proposed next steps for implementing BPR for overthe-counter medicines. Two other TGA speakers (TBC) will outline other developments in regulatory reforms throughout the TGA, including an update on the progress of the Transparency Review. Learning Objectives: • Business Process Reforms for Prescription/OTC • Transparency Reviews

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Rodney Peters Pharmacovigilance Manager, Baxter Pam Carter Director, Signal Investigation – Devices, TGA Invited speaker from the National Replacement Joint Registry (NJJR) Session Chair: Mike Flood Principal, Locus Consulting

Dr. Harry Rothenfluh Head, Office of Medicines Authorisation, TGA Session Chair: Helen Critchley Head of Regulatory Affairs and Product Safety, Sanofi-Aventis


2 11 ARCS

Day 1 Thursday 15 September 2011

Regulatory, Quality and Pharmacovigilance Congress

15 16 September, Canberra Time–& Session Information

Speaker Information

T5 IVD Regulation after 12 Months and what the Future Holds Synopsis: The new IVD regulations came into effect on 1st July 2010. This dramatically altered the regulation of in vitro diagnostics in Australia, whereby all IVDs supplied in Australia will be required to be included on the ARTG by 30th June 2014. This has meant significant changes for sponsors of IVDs and also the TGA in addressing the number of inclusions to be made and the level of information required. Many sponsors are just starting to prepare to make inclusions and the lessons learnt through the first 12 months need to be applied. It is also apparent that the costs associated with including a number of IVDs may greatly exceed the return generated by their sale in Australia. Additionally, there are now a number of new classes of IVDs such as those dealing with pharmacogenomic markers and co-technologies that raise issues in terms of the clinical evidence requirements for the assay.

Peter Kaylock Manager, IVD Assessment Section, Office of Devices Authorisation, TGA Jillianne Coles Regulatory Affairs Manager, Alere Australia Cliff Meldrum Deputy Director – Genetics, Hunter New England Local Health District Session co-Chairs: Dr. Peter Harman

Chief Executive Officer, IVD Australia Limited and Dr. Shelly Tang Director, Stellar Consulting

This session will look at the experience of the sector after the first year of the IVD regulations from the perspective both of the industry and the TGA. It will also seek to outline the requirements imposed on sponsors of IVDs dealing with genetic and co-technology markers. Learning Objectives: • Understand the impact of the new IVD regulations on sponsors • Understand clinical evidence requirement of new IVD markers

3:00 - 3:30pm 3:30 - 5:00pm

Afternoon Tea & Trade Exhibition Concurrent Sessions Bob Tribe Consultant/Owner, Bob Tribe

T6 PIC/S and Quality Risk Management Synopsis: The session will examine the current thinking around Quality Risk Management and how QRM guidelines are being implemented and interpreted in Australia. Examples of the tools available and the strategies for the application of Quality Risk Management in various activities in the pharmaceutical laboratory, will also be given. Level of Experience: Med-High T7 The Orphan Drug Program in Australia; experiences to date and where to next Synopsis: Australia’s Orphan Drug Program was introduced in 1998. The aim of the program is to encourage sponsors to develop and to market medicines for the treatment, prevention and diagnosis of rare diseases. Orphan drug designation is dependent on the di sease being rare, defined by criteria of prevalence (not more than 2000 persons), or commercial non_viability. A major benefit of the Australian program is the waiver of application and evaluation fees for the initial registration. Marketing approval of an orphan drug product in Australia involves two stages: an initial application for the product to be designated as an orphan, followed by an application for registration of the product. Almost 200 drug products have now been designated as orphans in Australia, and approximately 30% of these have since been registered for the specified rare disease. The most common therapeutic areas are oncology, haematology and infectious diseases. This session will comprise an outline of the current procedures for orphan drug designation and registration of orphan drug products, a review of the drugs and indications that have been designated as orphans, the types of epidemiological data required to support an orphan drug designation, and a case study to illustrate the clinical and regulatory challenges faced by developers of orphan drugs. Learning Objectives: • Understanding current procedures for orphan drug designation and registration in Australia • Understanding data requirements for orphan drug designation • Awareness of challenges faced by developers of orphan drugs

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Consulting,

John Montalto Senior Consultant,

PharmOut

Greg Jordan Director, ISC Analytics Session Chair: Rosalie Cull Managing

Director, TudorRose Consulting

Dr. Tony Gill Director, Experimental Products Section, Office of Scientific Evaluation, TGA Dr. Annie Solterbeck Director, Statistical Revelations John Oakley Regulatory and Medical Affairs Manager, Norgine Pty Ltd Session Chair: Dr. Brian Creese

Principal Consultant, INC Research


2 11 ARCS

Day 1 Thursday 15 September 2011

Regulatory, Quality and Pharmacovigilance Congress

15 16 September, Canberra Time–& Session Information

Speaker Information

T8 Clinical Evidence and expectations for all risk classifications for Medical Devices and Procedure Packs Synopsis: The last page of a typical TGA Medical Device Application requires the applicant to certify that the subject product complies with the Essential Principles and have available sufficient information to substantiate that compliance with the Essential Principles With regards to Essential Principles 14, the TGA expects manufacturers of all Medical Devices inclusive of Procedure packs to hold evidence that demonstrates that: • The medical device achieves its intended purpose(s) during normal conditions of clinical use • The known and foreseeable clinical risks and any adverse effects have been minimised • The risk of using the medical device is acceptable when weighed against the benefits inherent in the intended purpose(s) • Any clinical claims about the device’s performance and safety are supported by clinical data

Dr. Jon Rankin Chief Clinical Adviser, Office of Devices Authorisation, TGA

George Faithfull Vice President RA/QA,

Stryker Pacific Stryker Australia George Odero Regulatory Affairs Specialist, Medtronic Session Chair: Cliff Spong Director – Regulatory and Scientific Affairs, MTAA

Learning Objectives: • Expectations of Clinical evidence will be discussed in this session for all risk classifications with presenters from both Government and Industry covering required evidence for a wide range of kinds of products • Understanding Clinical evaluation requirements • Associated learnings from industry clinical practices for certain kinds of products T9 Packaging changes in New Zealand

Dr. Stewart Jessamine Group Manager

Amendments to NZ packaging and labelling requirements are expected to be passed into legislation in Q3 2011 and will be implemented in the period prior to Trans-Tasman finalisation. Please come and hear from Stewart Jessamine and NZ industry experts on the new requirements and the implications for sponsors

Roger Smart Director Regulatory Affairs,

5:00 – 6:00pm

Networking/Pre-dinner Drinks

6:00 – 11:00pm

Conference Gala Dinner

8

Corporate, Medsafe

Douglas Pharmaceuticals Caroline Norwood Regulatory Manager, Pharmaceuticals Solutions Session Chair: Anna Tang Regulatory Affairs Associate, Hospira


2 11 ARCS

Day 2 Friday 16 September 2011

Regulatory, Quality and Pharmacovigilance Congress

15 16 September, Canberra Time–& Session Information

8:00 - 8:300am 8:30 - 10:00am

Speaker Information

Registration, Welcome Coffee & Trade Exhibition Opening Plenary:

F1 The importance of PIC/S as a global coordinator in the development of regulatory guidelines Synopsis: PIC/S (Pharmaceutical Inspection Cooperation Scheme) celebrated two major events this year; in January the US FDA became the 39th member authority of PIC/S; in May it celebrated its 40th Anniversary with a major Symposium in Geneva which was attended by many Heads of Agencies, including Dr Margaret Hamburg, US FDA Commissioner. In her keynote address to the Symposium, Dr Hamburg called upon regulatory authorities to cooperate more closely and share information on GMP inspections, in particular in third countries.

Michael Arnold Global Business Process Head, Pfizer

Tor Graberg MPA Agency and Chairperson of PIC/S

Session Chair Bob Tribe WHO Expert

Committee Member, ISPE, Executive Consultant, PharmOut & Owner, Bob Tribe Consulting

Tor Gråberg, the current Chairman of PIC/S, will provide an overview of the PIC/S 40th Anniversary celebrations, as well as an update on other PIC/S activities; including expected future expansions within PIC/S involving GCP (Good Clinical Practice) and GDP (Good Distribution Practice), and expected changes to the PIC/S GMP Guide and PIC/S guideline documents. He will discuss the rapid expansion of PIC/S, particularly the interest being shown by regulatory authorities in the Asia Pacific region in becoming members of PIC/S and their move to realign their regulatory requirements to those of PIC/S. One part of the PIC/S GMP Guide is Annex 13 which covers the manufacture of investigational medicinal products. In addition, many PIC/S member authorities now undertake GCP inspections. Mike Arnold, Global Process Head for Pfizer’s Clinical Supply Chain, will discuss the use of interactive response technology (IRT) to manage clinical trial supplies, particularly expiration date monitoring. This is an important session for those involved with regulatory submissions and who wish to keep abreast of expected future regulatory requirements in the area of GMP and future technical developments related to the management of clinical trials.

10:00 -10:30am 10:30 - 12:00pm

Morning Tea & Trade Exhibition Concurrent Sessions

F2 Information Quality Integrity and Validation

Trevor Schoerie Principal, PharmOut Mark Atkins Managing Director,

Session on “Information Quality, Integrity and Validation”: Presentation 1: Mark Atkins - “Why information management is important (improving the productivity of your knowledge workers)” This presentation will focus on definitions of data and information, cost and risk of poor quality information, information quality management issues, initiatives and potential outcomes e.g. data warehousing, and methods of assessing the information environment of your business.

INTRAVERSED

Casper Graham CSL Biotherapies

Division, Software and Automation Validation Manager

Session Chair: Trevor Schoerie Principal, PharmOut

Presentation 2: Casper Graham (CSL)- “Part 11 Compliance” Presentation 3: Trevor Schoerie - “Tips for ensuring that your next computer system is GxP and Part 11 compliant, making the supplier do the work.” F3 Review of the TGA labelling and packaging requirements for medicines Synopsis: The TGA is initiating a review of the labelling and packaging regulatory framework. The review of labelling and packaging requirements will include prescription medicines, over the counter medicines and complementary medicines. The Australian system of regulating medicines includes labelling and packaging requirements. Therapeutic Goods Order (TGO) 69 ‘General labelling requirements’ specifies the type of information that must be provided to consumers on medicines labels and how the information must be provided (minimum font size etc). Packaging requirements specified in TGO80 Child resistant packaging aim to reduce the risk of inadvertent access to medicines by children. Dr Harry Rothenfluh will give a presentation on the scope and aims of the labelling and packaging review, from the TGA’s perspective. Carol Bennett, Chief Executive Officer of the Consumers Health Forum, will present the consumers’ perspective on labelling and packaging concerns. Additionally, a representative from the OTC medicines industry will provide the industry perspective on labelling and packaging requirements. Learning Objectives: • To provide an understanding of the scope and aims of the TGA’s labelling and packaging review; • To provide an understanding of the implications of the review to consumers and industry.

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Dr. Harry Rothenfluh Head, Office of Medicines Authorisation Carol Bennett Chief Executive Officer, Consumers Health Forum Session Chair: Elizabeth Joshi Bayer


2 11 ARCS

Day 2 Friday 16 September 2011

Regulatory, Quality and Pharmacovigilance Congress

15 16 September, Canberra Time–& Session Information

Speaker Information

F4 Social Media Synopsis; This session will focus on social media paradigm. Topics for discussion will include social media use in Australia with comparison to US with direct to consumer capabilities and UK. This will include how companies are using social media beyond marketing in areas such as Medical Information, Customer Service and Pharmacovigilance. Insight will be provided from the TGA and / or Medicines Australia Code of Conduct.

Rodney Peters Pharmacovigilance Manager, Baxter Will Collie Senior Manager External Affairs, Sanofi Aventis Session Chair: Rodney Peters Pharmacovigilance Manager, Baxter

• Solicited versus spontaneous reports via social media • Is the username enough for patient identification, what if the reporter is a child or adolescent. • How should companies follow up on case reports in order to obtain characteristics of a good case report? • Scope of accountability • Concerns of regulators Learning Objectives: • How companies are taking advantage of social media especially in with Facebook’s new policy on enabling two way conversations. • What methods are available and how are companies recognizing Adverse Events. • Development of good social media practices. • What is the perspective from TGA and Medicines Australia Code of Conduct regarding social media. F5 Bringing products to market with less panic and minimal ad hoc decisions Synopsis: Marketing and business development professionals enthusiastically identify new product opportunities in the marketplace. They then source appropriate suppliers and hand over the project to regulatory affairs professionals who achieve marketing approval. This is often and erroneously perceived to be the most difficult part of developing and launching a new product. The reality is the supply chain and product life cycle management processes consume most of an organisation’s time, effort and cost during product launches, but these “back room” (e.g. regulatory, technical and quality) processes are often poorly understood by the “front office” (e.g. marketing and senior managers). This workshop will provide an overview of the processes undertaken, and the issues faced in bringing a registered product from the supplier to the customer. It will describe how to make the process a lot less painful and panic stricken.

Dr. Clive Simon Director, The SPD

company

Robert Stringer Managing Director, K Pty Ltd

Rona Taylor Consultant, Commercial Eyes Session Chair: Dr. Clive Simon

Director, The SPD company

Participants will work through case studies that will illustrate the processes required and issues often faced in these areas.

12:00 - 1:00pm

Lunch & Trade Exhibition

1:00 - 2:30pm

Concurrent Sessions

F6 Requirements and responsibilities for industry, associated with release of the 17th edition of the Australian Regulatory Guidelines

Julian Guinan Senior Regulatory Affairs

Synopsis: Release of the 17th Edition of the guidelines for overseas manufacturers is associated with the new code of GMP and has important implications for sponsors seeking GMP clearance for their overseas sites. At this session representatives from TGA and industry will highlight and explore differences from the 16th edition and how industry can meet the updated requirements to ensure successful and timely GMP clearance.

Manufacturing Quality, TGA Tania Tadros Scientific Affairs Officer, Pfizer Australia Session Chair: Julian Guinan Senior Regulatory Affairs Associate, Bayer Australia Ltd

Learning Objectives: • Key areas of difference from the 16th edition • updated documentation requirements for Desk Top audits • New requirements for API GMP clearance • Preparation for a successful On-site Audit • Effective communication with TGA OMQ

10

Associate, Bayer Australia

Dr. Michael Carland Office of


2 11 ARCS

Day 2 Friday 16 September 2011

Regulatory, Quality and Pharmacovigilance Congress

15 16 September, Canberra Time–& Session Information

Speaker Information

F7 Update on the Biologicals Framework

Dr. Dianne Jackson-Matthews

Synopsis: Human cell and tissue therapies are now regulated under the Biologicals Framework which came into effect on the 31st of May, 2011. The presentation provides an update on the TGA’s experience with the framework to date. Key points of the framework are summarised. Some of the common deficiencies in Sponsor’s submission under the new framework are described and advice to avoid potential pitfalls is provided. Future developments for the framework are outlined. “Clinical development of a cell therapy in Australia, the industry perspective”

Principal, ERA Consulting (Australia) Pty Ltd Dr. Mark McDonald Head, Office of Scientific Evaluation, TGA Dr. Neil Frazer Chief Medical Officer, Prima Biomed Ltd

Session Chair: Dr. Dianne JacksonMatthews Principal, ERA Consulting (Australia) Pty Ltd

Conducting multi-site clinical trials for cell therapies presents special regulatory challenges, including potential impact when regulations change during the development life-cycle. The experience of the speaker in meeting these challenges in Australia and abroad will be presented. Advantages and disadvantages of different jurisdictions are discussed. “A global comparison of cell/tissue therapy regulations” With the introduction of the Biologicals Framework, Australia has developed a unique system for regulating human cell and tissue therapies. In this presentation the regulation of cell therapies in Europe and the US is summarised and compared to the Australian situation. Case studies are presented to illustrate potential challenges of different jurisdictions and possible strategies to navigate them. Learning Objectives: • An understanding of the Biologicals Framework in Australia • Regulatory strategies for conducting cell therapy clinical trials in Australia and abroad • A broad understanding of global cell/tissue therapy regulations F8 Publishing electronic submissions from an eCTD and Nees perspective – it’s not all magic

Mary Bogdanovski Regulatory Affairs

Synopsis: There is a common misconception that electronic submissions are magically generated by a push of a button. So when Regulatory Operations/Publishing Departments propose timelines for the preparation and publishing of an eCTD, these timelines seem unreasonable and often do not fit in with the tight timelines that organisations are consistently working in. With this in mind, this seminar seeks to educate stakeholders in the pre and post publishing activities involved in the generation of an electronic or paper published regulatory submission.

Mark Bailey Global Regulatory Publishing

This seminar will change your views on the publishing process and help you appreciate the intricacies of this specialised field, which has now become an integral part of regulatory submission compilation.

Manager, Operations , CSL

Manager, Regulatory Consulting & Submissions, INC Research James Hendry Regulatory Operations Manager, Liquent

Session Chair: Mary Bogdanovski Regulatory Affairs Manager, Operations , CSL

Learning Objectives: • To provide an understanding of the pre and post publishing activities involved in electronic publishing of regulatory submissions. • To provide a case study on what is involved in publishing a regulatory submission and how long this may take. • To understand the issues a publisher faces and how these are addressed. Dr. Susan Walters Ad hoc consultant

F13 Biosimilars – Why are there special regulatory requirements? Synopsis: When an innovator registers a new chemical entity, full quality, preclinical (toxicology) and clinical data are submitted in support of the application. After expiry of any relevant patent, generic versions may be registered on the basis of quality and bioequivalence data. The bioequivalence study compares the plasma concentration / time profiles of the generic and innovator using statistical and clinical criteria. If they are deemed equivalent, new toxicology and clinical data are not required. But that’s for a small molecule. Why are there different requirements for second entry biological medicines? The guidelines for these products still require pharmacokinetic data, but these are not sufficient for registration as is the case for small molecules. Regulatory requirements for biosimilars will be discussed and explained. Learning Objectives: • Knowledge of regulatory requirements for second entry biological medicines • Understanding why these requirements are different to those for second entry small molecules

2.30pm - 3.00pm

Afternoon Tea & Trade Exhibition

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for WHO, the Global Fund and other international organizations. Dr. Kevin Grant. Principal Biochemist, Office of Laboratory and Scientific Services, TGA Dr. Jamie McGinness Head, Clinical Evaluation Section 4, Office of Medicines Authorisation, TGA Session Chair: Dr. Susan Walters Ad hoc consultant for WHO, the Global Fund and other international organizations.


2 11 ARCS

Day 2 Friday 16 September 2011

Regulatory, Quality and Pharmacovigilance Congress

15 16 September, Canberra Time–& Session Information

3:00pm - 4:30pm

Speaker Information

Concurrent Sessions

Mary Flannery Regulatory Affairs Manager,

F9 TGA on-site GMP audit of an overseas manufacturing site – what does it mean for an Australian regulatory affairs department Synopsis: According to the TGA’s Guidance on GMP clearance for overseas manufacturers, the TGA reserves the right to undertake an on-site audit of an overseas manufacturing site. If this happens, the Australian sponsor regulatory affairs department is often the first point of contact for the TGA when an overseas on-site audit is planned. This session will describe the steps involved in arranging such an audit, how the Australian sponsor can help the site prepare, what happens during the audit, and what can be needed to close out an audit. Hear from a TGA auditor and an Australian regulatory professional who has accompanied a TGA audit about what can help make this a good experience for all concerned.

Eli Lilly Australia Pty Ltd

Dr. Dragana Milic Manager, Medical

Devices Audit Section, Office of Manufacturing Quality, TGA

Session Chair: Ailsa Surman Eli Lilly

Learning Objectives: By attending this session you will: • understand the preparatory activities required before an overseas on-site audit • understand more about the link between your ARTG entries and what will be audited • know what to expect during and after an audit • learn some hints & tips about what helps an overseas on-site audit run smoothly F10 Quality Module 3 and beyond

David Edmonds Principal, CMC

Synopsis: Submission for approval to market a new drug or to change registration details is only the commencement of the process, leading to the supply of product to the market of a current registration.

Dr. Mark McDonald Head , Office of

Module 3 of a submission includes the detailed chemistry of the drug substance (properties, characterisation and specifications) and details of the dose formulation. Methods of manufacture, packaging, testing and their respective validations, and requisite in-process and final specifications are also presented. All these parameters are integrated into a totality with establishment of shelf life/storage conditions with supporting stability studies for both drug substance and product.

Regulatory

Scientific Evaluation, TGA Dr. John Cullen Technical Services Manager, Aspen Pharma

Session Chair: David Edmonds

Principal, CMC Regulatory

A submission is the beginning; specifications for drug substance and manufactured product, and stability studies are two major parameters for on-going supply to the market under GMP by TGA accredited manufacturers. Dr Mark McDonald, Head, Office of Scientific Evaluation will present TGA’s experiences on commonly observes deficiencies of submitted drug substance data (ie Module 3 3.2.S) and/or Certificate of suitability to European Pharmacopoeia (CEPs). David Edmonds will describe the structure of specifications, their relationship with test methods and those specifications which affect product performance, rather than purity. Dr John Cullen will describe stability studies of products in submissions and subsequent GMP on-going studies with reference to routine batch release and extension of dating. Learning Objectives: • Improvement of submissions to TGA regarding Module 3 drug substance data. • Structure of specifications including some specific physical characteristics, essential for consistent dose form performance but not covered by Pharmacopieal requirements. Relationship of specifications and their test methodologies. • Requirements of stability studies. Relationship of registration stability data and on-going studies. F11 The Regulatory Super Sleuth

Cathie Oats Director – Communications,

Synopsis: Regulatory strategies are interwoven with initiatives from the wider organisation in a labyrinth of focus points within an articulated strategic plan. Keeping abreast of regulator and competitor developments is an integral component of business strategies, though is often considered an auxiliary function of regulatory professionals. Whether keeping up with regulatory consultation documents or approvals, or monitoring industry or organisational movements, regulatory intelligence can form an invaluable component of your overall regulatory strategy. With the immediacy that technology allows, and the abundance of the information at hand, being contemporary in your approach to regulatory intelligence will assist in identifying an approach that suits your organisation. Learning Objectives: • To explain how regulatory intelligence can contribute to your organisation’s competitive edge • To provide useful tips to tailor your efforts for maximum return.

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Office of Parliamentary and Strategic Support, TGA Colin Wilcox Office of Information Management, TGA Dr. Mary Nteris Associate Director, INC Research Session Chair: Dr. Mary Nteris INC


2 11 ARCS

Day 2 Friday 16 September 2011

Regulatory, Quality and Pharmacovigilance Congress

15 16 September, Canberra Time–& Session Information

Speaker Information

F12 RMP implications for Prescription Medicine Registrations

Research

Synopsis: The requirement for the use of a Risk Management Plan (RMP) as part of a submission for prescription medicines was introduced by the TGA on 1 April 2009. This requirement had already been in existence in the European Union for a few years. RMPs are now required for new chemical entities, significant extensions of indications, extensions to the paediatric population and applications which result in different dosage forms, a change in the treatment population or a change in the safety profile of the drug. An RMP is a set of pharmacovigilance activities and interventions designed to identify, characterise and manage risks relating to a medicine. It consists of an overview of the safety profile of the medicine, a pharmacovigilance plan and a risk minimisation plan. The RMP covers the entire life cycle of the product. Therefore, the RMP will need to be periodically updated to reflect new knowledge and understanding of the safety profile of the product This session will comprise an outline of an RMP with a detailed description of the elements of an RMP, feedback from the TGA on the adequacy and completeness on RMPs submitted in the past two years and an industry perspective on RMPs. Learning Objectives: • Understanding the structure, nature and data requirements for an RMP in Australia • Understanding the nature of pharmacovigilance and risk minimisation activities which can be used in the development of RMPs • Awareness of the findings of the TGA in the adequacy and completeness on RMPs submitted since the program began • Awareness of the challenges faced by industry in the submission of RMPs

13

Dr. Ian Boyd Principal, Ian Boyd Consulting Dr. Jane Cook Head, Office of Product

Review, TGA

Session Chair: John Leach Regulatory Affairs Manager, Aspen Pharmacare


2 11 ARCS

Regulatory, Quality and Pharmacovigilance Congress

™®

15 – 16 September, Canberra

ofessional Development for the Therapeutics Industry ™

15 – 16 September, Canberra

REGISTRATION INCLUSIONS

HOW TO REGISTER

Two day registration • Access to all Congress presentations (permission permitting) on the ARCS website • Admission to all Scientific Sessions • Admission to Trade Exhibition • Admission to the Congress Dinner & Pre-dinner Drinks • Delegate Satchel • Morning, Afternoon Tea and Lunch daily

Check with your colleagues and manager to see if you have five or more, or 10 or more registrants and so qualify for the respective discounts. If you do, then an organiser (who may or may not be attending) will need to register you as part of a group to receive the group discount (see below).

One day registration • Access to all Congress presentations (permission permitting) on the ARCS website • Admission to all Scientific Sessions (for specified day) • Admission to Trade Exhibition (for specified day) • Admission to the Congress Dinner & Pre-dinner Drinks • Delegate Satchel • Morning, Afternoon Tea and Lunch (for specified day) Group registrations Both two & one day registrations Register five or more staff from the same organisation at the one time, for any mixture of Congress registrations and receive 10% off Congress registration fees or register 10 or more and receive 15% off (excludes Membership fees where selected). Delegates must work for the same organisation and pay on the one invoice. Please read the information below for details of how to register as a group. Non member registration When registering for Congress at the Non-Member rate, delegates may elect to join ARCS Australia with membership to 30 June 2012 at no further cost. Changes to your registration details Changes to your session preferences can be made on-line once you have completed your registration. A password will be emailed to you as part of your immediate confirmation. If you require changes to the social functions, then please contact the ARCS Business Office on 02 8905 0829. Please consider your session and function preferences carefully during registration. Cancellations Cancellations must be notified in writing to the ARCS Business Office before Friday 9 September 2011 a full refund, minus a $150 processing fee and/or costs from changes to group numbers, will be provided. No refunds will be given for cancellations after COB 9 September 2011. Substitutions are allowed. Event reporting By registering for this conference, you agree to report the meeting and its content without bias or misrepresentation. All speaker names and the conference should be attributed as the source, in any articles or publication of proceedings or subsequent presentations or summations. Copyright to the presenters should be assumed unless it is clearly stated otherwise. All details reported in public media should be verified with the presenter prior to publication.

Individual Registration • Visit www.arcsconferences.com • Click Register • Click individual as the type of registration • Select your registration type (i.e. member/non member) • If you are a member, enter your Membership Number, First name, and Last name or if a non member enter your full contact details. • Choose the days you wish to attend, click continue • Confirm your contact details, click continue • Select the sessions you wish to attend, click continue • Select if you will be attending the Conference Dinner, Pre-Dinner Drinks and if you wish to contribute to the carbon offset scheme, click Continue • Review the confirmation If correct, then click Continue If incorrect, then click on the heading of the section that requires changing and update where needed • Enter your credit card details and click Submit. Payment must be made by credit card unless you have prior arrangement with ARCS (unless a group registration). A confirmation email will be sent to you as soon as you click Submit. Please keep this handy as it contains your tax invoice and unique password for you to login to the system to change your session preferences and download session handouts. Group Registration • If your company has five to ten registrations of any kind (1 or 2 days) then one person needs to enter these as one group to receive a 10% or 15% discount respectively. Group registrations may be paid by credit card or through other means by prior arrangement with ARCS Please note: Individuals can not be added to groups after the online registration is complete, but additional groups can be registered. • First you will need to determine who will be coordinating the group registration • Once this has been determined, tell the coordinator your: – Contact details (and Membership ID if registering as a member for the member rate) – The type of registration (2 or 1-day, member or non-member etc for each person) – If you will be attending the Conference Dinner and Pre-Dinner Drinks – If you want to make a Carbon Offset Contribution Once the coordinator has completed the registration, you will receive a confirmation email which contains a link and password to enter your session details. Please login as soon as you receive this email to secure your spot, as some sessions may have limited spaces.

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2 11 ARCS

Regulatory, Quality and Pharmacovigilance Congress

™®

15 – 16 September, Canberra

Professional Development for the Therapeutics Industry ™

GENERAL INFORMATION VENUE The National Convention Centre is the largest purpose-built meetings and events facility in the ACT. The Centre is conveniently located between Sydney and Melbourne and is a great destination for delegates with easy access via plane, bus, train or car.

15 – 16 September, Canberra

ACCOMMODATION Just a two minute walk from the National Convention Centre, The Crowne Plaza is the most conveniently located hotel in the area. ARCS has arranged the following special rates with the hotel as part of our conference room block. • Superior King Room with full buffet breakfast for one - $230/night • Superior Twin Room with full buffet breakfast for one - $230/night

PUBLIC TRANSPORT

• Deluxe King Room with full buffet breakfast for one - $270/night

BUSES Murrays coaches offer over 100 services a week from Sydney to Canberra. Go to www.murrays.com.au for more information or call 13 22 51.

• Deluxe Twin Room with full buffet breakfast for one - $270/night

AIR The National Convention Centre, situated in the city centre is just a ten-minute drive from the airport. We recommend you visit the domestic airline websites of Qantas, JetStar and Virgin Blue. These carriers often have sale fares which could make your trip to Congress all the more affordable. TRAINS CountryLink offers two daily XPLORER rail services from Sydney to Canberra. PARKING Parking for more than 400 cars is available beneath the National Convention Centre currently at a cost of $10 per vehicle per day, or $6 per four hours or part thereof. The National Convention Centre car park can be entered off Constitution Avenue.

To take advantage of these special rates call 02 6247 8999 and quote the block code which is “DEL”. A comprehensive list of other hotels to suit a range of budgets can be found on the Congress website at www.arcsconferences.com. REGISTRATION DESK The Registration Desk will be located in the Main Foyer of the National Convention Centre and will be open from 8.00am to 5.00pm each day. Upon arrival on your fi rst day, please report to the Registration Desk to receive your delegate satchel, name badge and social event ticket/s. NAME BADGES All delegates will be given a name badge at registration. This badge will be the official pass to sessions, teas, lunches and official social functions. It is necessary for delegates to wear their name badges at all times when on-site. CONTINUING PROFESSIONAL EDUCATION (CPE) POINTS Name badges will be scanned as you enter sessions to enable CPE points to be added to your record - please ensure you are wearing the correct name badge! See the Registration Desk for assistance.

EXHIBITORS •

ARCS Australia

McCloud Consulting

Adriot People

OnQ Recruitment

BioPharmaceutical Solutions

Pharmaceutical & Medical Professionals

Hahn Healthcare

PharmOut

Suite 802, 28 Clarke Street, Crows Nest NSW 2065 Phone: 02 8905 0829 Fax: 02 8905 0830 Email: arcs@arcs.com.au Web: www.arcs.com.au


ARCS Program