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Virtual Event

Sep 18, 2020 8:30 AM - Sep 18, 2020 5:30 PM

(Central Europe Standard Time)

4051 Basel, Switzerland

Clinical Trial Regulation Information Day for CEE Countries

Are Central and Eastern European Union member states ready to implement the new EU Clinical Trial Regulation (536/2014)? Join the discussion on managing clinical trials in the face of changes coming soon in 2021.

Back to Agenda

Session 1: Clinical Trials Regulation Overview, Objectives and Why the Replacement of EU Directive is Needed

Session Chair(s)

Steffen Thirstrup, MD, PhD

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

Key Changes from Directive to Regulation and Associated Challenges

Massimiliano Sarra, PhD, MPH

Italian Medicine Agency (AIFA), Italy

Permanent official and CTFG Secretary

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