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Session 3: Regulatory Planning – Preparing for Day 1
Session Chair(s)
Zamshed Harun
CEO
Makaris Strategies, Switzerland
This session will review issues related to licensing, for Day 1 and looking forward. This will summarise what we know, what we still don’t know and what we have to do to be prepared.
Speaker(s)
Industry: Day One Contingency Plans and Practical Considerations
Chris Walker, MSc
Amgen, United Kingdom
VP, Head of Regulatory Affairs (EU,LATAM,MiddleEast,Africa,CAN)
EMA Relocation and Business Continuity Planning: Insights in the Operations and Relocation Preparedness Task Force
Noël Wathion, RPh
European Medicines Agency, Netherlands
Deputy Executive Director
Decentralised Arrangements & How Other National Regulators Are Responding to the Brexit Challenge
Peter Bachmann
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Deputy-Head, European Union and International Affairs
Responding to the Brexit Challenge – Ireland
Rita Purcell, LLM
Health Products Regulatory Authority (HPRA), Ireland
Deputy Chief Executive
MHRA Relocation and Preparation for Post-Brexit Regulatory Framework
Keith McDonald, MSc
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Deputy Director, Licensing Division