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Session 1: Clinical Trials Regulation Overview, Objectives and Why the Replacement of EU Directive is Needed
Session Chair(s)
Steffen Thirstrup, MD, PhD
Chief Medical Officer
European Medicines Agency, Netherlands
Session 1: Clinical Trials Regulation Overview, Objectives and Why the Replacement of EU Directive is Needed
Speaker(s)
Key Changes from Directive to Regulation and Associated Challenges
Massimiliano Sarra, PhD, MPH
Italian Medicine Agency (AIFA), Italy
Permanent official and CTFG Secretary