CRED: European Regulatory Procedures

Aim

This course is intended for all those working within European regulatory affairs.

Day 1 will cover the strategic considerations

• Devising a company strategy for effectively working with the regulators including how to ensure a winwin outcome; the role of the European Medicines
  Agency, CHMP, CMD(h), EU Commission and national authorities in the procedures
• Integrating scientific advice into your strategic decision including how and where to obtain it
• How to decide which procedure and which Regulatory agency to increase your chance of success including an overview of current procedures and accompanying legislation
• Planning for the application filing including what you should avoid in order to achieve a successful result; how to manage your company’s expectations.

Day 2 will cover Practical Considerations

• An overview and comparison of the Centralised and Mutual Recognition/Decentralised procedures and accompanying legislation
• How to plan, compile and manage the applications including what the guidelines don’t tell you; pitfalls to avoid to achieve a successful result
• How to work with the regulators to maximise your chance of a positive outcome including the role of the European Medicines Agency, CHMP, EU Commission and national authorities in the procedures
• Appeals and hearings including the articles and what they mean in practice.

Who should attend

• The less experienced Regulatory Professional who requires comprehensive information on a subject
• The experienced professional who is a newcomer to a particular regulatory aspect
• Anyone who wishes to update their knowledge in a particular subject area

Topics include

Day 1

• Overview of European Regulations
• Developing your Global Filing Strategy
• Developing Strategy for Non-NCEs
• Finalising your European Regulatory Strategy
• Working Effectively with Regulators – Regulators Perspective
• Working Effectively with Regulators – Regulators Perspective

Day 2

• Key EU Region Considerations
• Decentralised and Mutual Recognition Procedures
• Centralised Procedure – The Details
• Health Technology Assessment
• Working together with the Regulators to ensure Success

Speakers include

• Marie-Hélène Pinheiro, Regulatory Affairs Adviser, European Medicines Agency (EMA)
• Bob Clay, Vice President, Oncology and Infection, Astra Zeneca, UK
• Mike Bateman, Director – European Regulatory Consulting and Submissions, Kendle International Ltd, UK
• Jackie Mitchell, Director Regulatory Affairs, Archimedes Pharma Ltd, UK
• Mira Pavlovic, Head of Unit for National Scientific advice, AFSSAPS and vice chair EMA SAWP, France
• Kim Wharton, Managing Director, Regulis Consulting Ltd., UK
• Dave Gilbert, Vice President, NDA Regulatory Science, UK
• Anna Somuyiwa, Director, Segulah Consulting Ltd, UK