5th Annual European Regulatory Affairs Summer School

Essential foundation in past, present, and pending pharmaceutical regulation

Dates	29 Jul 2008 to 31 Jul 2008
Location	Fitzwilliam College, University of Cambridge, Cambridge United Kingdom
Organiser	Informa Life Sciences

Summary

You will learn about:

The current regulatory system and efforts towards creating a harmonised European framework
Understanding your role in the context of drug development and clinical affairs
Ensuring that clinical trials meet with regulatory approval in Europe
Routes to obtaining Scientific Advice in Europe
Submission formats and building successful dossiers for Europe, including the eCTD
Key benefits and drawbacks of the centralised, decentralised and mutual recognition procedures
What the regulators look for in Readability Testing
Regulatory requirements for orphan drugs and paediatric research
The importance of on-going pharmacovigilance and risk management

Speakers	Gabriele Eibenstein, Head of Drug Regulatory Affairs, BfArM, Germany Klaus Menges, Head of Scientific Quality Assurance, BfArM, Germany Sabine Strauss, Head of Pharmacovigilance, Medicines Evaluation Board, The Netherlands David Lyons, Senior Medical Officer, Irish Medicines Board, Ireland Nina Bjelogrlic-Laakso, Senior Clinical Assessor, SAWP alternate, National Agency for Medicines, Finland Alastair Nixon, Submissions Publishing, EFPIA eCTD topic group member, UK Joerg Schnitzler, Associate Director, Submissions Management, Wyeth, UK Adriaan Fruijtier, Director, Regulatory affairs, CATS consultants GmbH, Germany Geoff Williams, Site Head of regulatory Operations, Roche Products Ltd, UK Lesley Winch, Associate Director GCQA Europe, Johnson & Johnson PR&D, UK David Fisher, Global QA advisor, Lilly, UK Andrew Cooper, AstraZeneca, UK Jasna Rakic-Connors, AstraZeneca, UK Teresa Pepper, Senior Manager, Regulatory Affairs, Amgen, UK Sarah Hall, Medical Information & Pharmacovigilance Manager, Takeda, UK Theo Raynor, Professor of Pharmacy Practice, University of Leeds & LUTO research Ltd, UK Neil Edwards, Managing Director, Sirius Regulatory Consulting Ltd, UK Graeme Ladds, Director, Pharsafer, UK Gillian Holmes, Senior Consultant, Parexel consulting, UK

Speakers

Gabriele Eibenstein, Head of Drug Regulatory Affairs, BfArM, Germany
Klaus Menges, Head of Scientific Quality Assurance, BfArM, Germany
Sabine Strauss, Head of Pharmacovigilance, Medicines Evaluation Board, The Netherlands
David Lyons, Senior Medical Officer, Irish Medicines Board, Ireland
Nina Bjelogrlic-Laakso, Senior Clinical Assessor, SAWP alternate, National Agency for Medicines, Finland
Alastair Nixon, Submissions Publishing, EFPIA eCTD topic group member, UK
Joerg Schnitzler, Associate Director, Submissions Management, Wyeth, UK
Adriaan Fruijtier, Director, Regulatory affairs, CATS consultants GmbH, Germany
Geoff Williams, Site Head of regulatory Operations, Roche Products Ltd, UK
Lesley Winch, Associate Director GCQA Europe, Johnson & Johnson PR&D, UK
David Fisher, Global QA advisor, Lilly, UK
Andrew Cooper, AstraZeneca, UK
Jasna Rakic-Connors, AstraZeneca, UK
Teresa Pepper, Senior Manager, Regulatory Affairs, Amgen, UK
Sarah Hall, Medical Information & Pharmacovigilance Manager, Takeda, UK
Theo Raynor, Professor of Pharmacy Practice, University of Leeds & LUTO research Ltd, UK
Neil Edwards, Managing Director, Sirius Regulatory Consulting Ltd, UK
Graeme Ladds, Director, Pharsafer, UK
Gillian Holmes, Senior Consultant, Parexel consulting, UK

Who should attend

This conference is designed to meet the wants and needs of the professionals from the pharmaceutical, generics and biotech companies involved in all aspects of regulatory affairs in Europe