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Session 1: Clinical Trial Regulation Implementation – Latest Status
Session Chair(s)
Nick Sykes, MS
Policy Advisor, Regulatory Strategy
EFPIA, Belgium
This session gives a high-level update on status of the implementation of the Clinical Trials (CT) Regulations and an update on available guidance and implementation status in the EU Member States. The aim is to ensure all delegates are up-to-date with latest developments.
Speaker(s)
Elke Stahl, PhD
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Senior Expert, Clinical Trials Department