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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)
Chris Walker, MSC
VP, Head of Regulatory Affairs (EU,LATAM,MiddleEast,Africa,CAN), Amgen, United Kingdom
Industry: Day One Contingency Plans and Practical Considerations
Noël Wathion, RPH
Deputy Executive Director, European Medicines Agency, Netherlands
EMA Relocation and Business Continuity Planning: Insights in the Operations and Relocation Preparedness Task Force
Peter Bachmann
Retired from Head International Liaison Office and Conferences, Executive Depart, Federal Institute for Drugs and Medical Devices (BfArM), Germany
Decentralised Arrangements & How Other National Regulators Are Responding to the Brexit Challenge
Rita Purcell, LLM
Deputy Chief Executive, Health Products Regulatory Authority (HPRA), Ireland
Responding to the Brexit Challenge – Ireland
Keith McDonald, MSC
Deputy Director, Licensing Division, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
MHRA Relocation and Preparation for Post-Brexit Regulatory Framework
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