The 7th Annual TOPRA Symposium

Better access to medicines in a changing regulatory environment

Organised in conjunction with Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom.

This important annual Symposium is now recognised as a key event in the European calendar of all those working in the health care regulatory affairs arena.

Aim

This annual Symposium is for all those involved within regulatory affairs and brings together representatives of industry and the regulatory agencies and the European Commission to discuss and understand today’s regulatory issues and debate the future plans for regulation. This is the key annual European regulatory forum for all those involved in the pharmaceutical sector
and aims to bring you all the latest information and importantly what is coming over the horizon. There will also be ample time to network in the breaks and also view services from exhibitors in the industry and the regulatory bodies.

Who should attend

All those working in the industry, consultants, individuals working within health care regulatory such as patient groups, pharmacists, academia and
regulatory authorities and those in the pharmaceutical industry who have medical devices or use devices in combination with their medical products.

Programme Committee

This is drawn from the UK MHRA, TOPRA members, European Medicines Agency, national regulatory agencies and industry.

Programme includes:

Improving Access - the Interface of Health Technology Assessment and the Regulatory Process

This session will provide an overview of current regulatory and HTA-related requirements and how these may best be addressed in drug development to ensure patients can access new medicines within their national health care systems. With the EMA and the European network for health technology assessment (EUNetHTA) having announced closer cooperation, and some Member States now piloting joint regulatory and HTA scientific advice, this is a highly relevant topic for today’s regulatory professional.

Improving Access - using Scientific Advice and Early Access Schemes

This session will cover Scientific Advice at European level at EMA but also from a National Agency and Industry perspective. It will discuss recent experiences of pilot Joint Scientific Advice including Health Technology Assessment (HTA) and how this might develop in the future. Is Parallel Scientific Advice between US and EU still alive?

Focus on the Medicines and Healthcare products Regulatory Agency (MHRA)

In this session the MHRA will review and discuss the role that a national agency can play within the European health care system and they will touch upon some of the current and future challenges facing us such as access to medicines, risk management and how best to communicate in the healthcare arena.

Improving Access - through Clinical Trials Harmonisation

The Clinical Trials Directive (CTD) was meant to streamline the approval of clinical trials across Europe but the reality has not lived up to this ideal. Several challenges remain that were highlighted in the outcome of the assessment of the functioning of the CTD by its main users. This session will explore how the European Commission has been reviewing the operation of the CTD and its current plan to address the issues raised, how the CTFG have responded to the need for improved harmonisation across the EU, and the position of the EMA and industry on the topic.

Globalisation of Pharmaceutical Regulation – what do Agencies Discuss behind Closed Doors?

In this session, the US FDA, EMA, EU National Health Authorities and the Japanese Health Authority procedures for sharing information will be presented. A panel discussion with session speakers and invited guest(s) will offer the opportunity to explore the topic more fully.

From Risk Management to Benefit/Risk Management

This session will cover the challenges in the changing regulatory environment as we move from an emphasis on risk management to benefit-risk management and the need for regulatory affairs professionals to update their knowledge and take a leadership role in this important changing regulatory area.

The Intellectual Property Minefield - do SPCs, Data Exclusivity Provisions and Patents Affect Access?

This session will look at the various aspects of intellectual property rights that are of importance to regulatory strategies both during drug development but also when looking for developments to already approved products. The speakers will provide a better understanding of the concepts but also discuss some of the latest developments and trends.

Improving Access – how can all Stakeholders make a Contribution?

This session will look at the important contribution of all stakeholders, specifically patients, healthcare professionals, academia, pharmaceutical industry, EU institutions and regulatory agencies, in achieving better health outcomes and improved access. The session will discuss the input of such stakeholders to the regulatory decision-making process. The experiences of interaction between stakeholders and working parties at national and EU level in strengthening transparency and public trust in the EU regulatory process will be discussed.

Programme subject to change.

Speakers include

• Mary Baker, President of the European Federation of Neurological Associations (EFNA), UK
• Alan Barge, VP and Head of Oncology and Infection, Drug Development, AstraZeneca, UK
• Paolo Biffignandi, TOPRA President 2009/2010 including Announcement of the 2010/11 Board
• Jérôme Boehm, Policy Officer - Health Systems, Health and Consumers Directorate General, European Commission
• Hilde Boone, EMA Liaison Official, FDA, USA
• Chris Dafforn, Regulatory Affairs Director, CMC Regulatory Compliance, Global Quality Operations, AstraZeneca, UK
• Stuart Dollow, Chief Development Officer, Norgine, UK
• Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency (EMA)
• Falk Ehman, S&E Sector, European Medicines Agency
• Mats Ericson, Director Regulatory Affairs – Policy, Amgen, France
• Krystyna Fielden, Manager, PLATs (Product Lifecycle Assessment Teams), Licensing Division, MHRA, UK
• Stuart Finnie, Associate Director Reg CMC, AstraZeneca, UK
• Bruno Flamion, Chair, Scientific Advice Working Party, EMA and University of Namur, Belgium
• Sue Forda, Vice President, International Regulatory Affairs, Eli Lilly and Company, UK
• Beatrix Friedeberg, Director Regulatory Policy and Intelligence, AstraZeneca, UK
• Stefan Fuehring, Unit SANCO C8 - Pharmaceuticals – Health and Consumer’s DG, European Commission
• Simon Gregor, Director of Communications, MHRA, UK
• Philip Hall, Director, European Submission Operations, Abbott Laboratories, UK
• Craig Hartford, VP, Safety Surveillance and Risk Management, Worldwide Safety Strategy, Pfizer Medical, UK
• Yoshikazu Hayashi, International Liaison Officer responsible for EU Relations, PMDA, Japan
• Ian Hudson, Director of Licensing, MHRA, UK
• Alan Hunter, Chair of Symposium working party
• Zubair Husain, TOPRA President 2010/2011, Pfizer, UK
• Trevor Jones, Director General of the Association of the British Pharmaceutical Industry (ABPI), UK
• Margareth Jorvid, LSM group, Sweden and TOPRA Board Director
• Aginus Kalis, Executive Director, College ter Beoordeling van Geneesmiddelen, Medicines Evaluation Board, the Netherlands
• Carlos Langezaal, Director Regulatory R&D Portfolio, Sanofi-Aventis Inc.,USA
• Meg Leahey, Associate Director Regulatory Affairs, Pfizer, Ireland
• Bengt Ljungberg, Head of Section Pharmacotherapy, MPA, Sweden
• Murray Lumpkin, Deputy Commissioner for International Programs, Food and Drug Administration (FDA), USA
• Marisa Matias, MEP, Portugal
• Clare McGrath, Senior Director HTA Policy, Europe/ROWD, Pfizer, UK
• Cecil Nick, Vice President (Biotechnology), Paraxel, UK
• Lawrence Phillips, Benefit-Risk Project, IMI-PROTECT project, Human Unit, EMA
• Isabella Sanderfelt, Head of Regulatory Affairs, Pfizer, Sweden
• Nuno Simoes, Advisor to the Executive Board of INFARMED (Portuguese National Authority of Medicines and Health Products), Portugal
• Rosalind Smyth, Chair of the UK Medicines for Children Research Network, UK
• Janice Soreth, US FDA Liaison at EMA
• Rafe Suvarna, Unit Manager, Vigilance and Risk Management of Medicines, MHRA, UK
• Fergus Sweeney, Head of Compliance and Inspection, EMA
• June Raine, Director of Vigilance and Risk Management of Medicines, MHRA, UK
• Andrea Rappagliosi, Vice President European Government Affairs & Head of Brussels Office, GlaxoSmithKline, Belgium
• Kristin Raudsepp, Director General, State Agency of Medicines, Estonia
• James Ritchie, Director, Regulatory Policy, GlaxoSmithKline, UK
• Tony Rollins, Managing Counsel, European Patents, Merck & Co Inc. UK
• Helene Thybo, Corporate Regulatory Intelligence Specialist, Regulatory Affairs and Safety, Leo Pharma, Denmark
• Stuart Walker, Founder, CMR International Institute for Regulatory Science, UK
• Noël Wathion, Head of Unit Patient Health Protection, EMA
• Lynda Wight, Executive Director, TOPRA
• Michael Wilks, Past President of the Standing Committee of European Doctors, Belgium
• Alison Wilson, Principal Consultant, Cell Data Services, UK
• Kent Woods, Chief Executive, Medicines and Healthcare Products Regulatory Agency (MHRA), UK

Speakers subject to change.

There will be sufficient time for questions during the panel discussions throughout the Symposium.

In addition the Special Interest Networks (SPIN) will also be organising parallel special sessions covering “e” working (eRA SPIN), Variations (CMC SPIN) and Biotechnology.

The MHRA will hold a session on Monday 4th October 2010 to reflect on the activities of this important regulatory agency.

Also on Monday 4th October, Symposium SME session - Regulatory challenges and support for SME companies (www.topra.org/smeday2010)

In addition the following events are taking place on the 5th October 2010:

• The 5th TOPRA Annual Medical Devices Symposium (www.topra.org/medicaldevsym2010)
• The 5th TOPRA Annual Veterinary Medicines Symposium (www.topra.org/vetsymposium2010)
• The annual Gala Dinner where students in Regulatory Affairs and Medical Technology will receive their diplomas and MSc qualifications.
• The gala evening will conclude with the industry's very first awards ceremony recognising what is best about the regulatory profession and the people within. (www.regulatoryaffairsawards.org)

View a short film about last year's Annual Symposium in Stockholm, Sweden