CRED-European Regulatory Procedures: strategy and practice

European Regulatory Procedures - Strategic and Practical Considerations

Aims of the course:

This CRED Workshop is designed to provide information on European Regulatory procedures from a strategic and a practical point of view. If you are about to plan a marketing application in Europe then this course will provide you with practical advice on how to work with the regulators, how to plan scientific advice, which procedures can be used, planning your filing, negotiations during review and the appeals process and how to manage your company’s expectations. There will also be workshop sessions to help reinforce the theoretical presentations.

Who should attend

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

Speakers include

• Bob Clay, Pfizer, USA
• Debbie Haynes, Genentech UK
• Patrick Salmon, Irish Medicines Board,Ireland
• Kim Wharton, Regulis Consulting Ltd,UK
• Philip Senior, GlaxoSmithKline, UK
• Dave Gilbert, NDA Regulatory Science, UK

Course content

Day 1: 12th November - Strategic considerations

• Overview of European Regulations including role of regulatory bodies, orphan drugs, paediatrics and SME’s
• Developing your global Filing Strategy
• Developing Strategy for Non – NCEs
• Finalising your European Regulatory Strategy including trade names and pre-submission meetings
• Working Effectively with Regulators – Regulators Perspective
• Case Study Session and Feedback
• Question & Answer Session

Day 2: 13th November - Practical considerations

• Key Eu Region Considerations including CTD/ eCTD, “user testing”, translations, risk management and PiPs
• Decentralised Procedure – The Details Mutual Recognition Procedure
• Centralised Procedure – The Details
• Case Study
• Working together with the Regulators to Ensure Success including managing internal and external communications

Lifelong Learning (LLL):
The workshop contributes 6 hours per day of training to your LLL (sometimes known as Continuing Professional Development) and will enhance your Regulatory Skills relevant in the areas of human and veterinary medicines