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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
Retired from Head International Liaison Office and Conferences, Executive Depart
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