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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)
Massimiliano Sarra, PHD, MPH
Permanent official and CTFG Secretary, Italian Medicine Agency (AIFA), Italy
Key Changes from Directive to Regulation and Associated Challenges
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