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Novotel Bucharest City Centre

Oct 22, 2019 8:00 AM - Oct 22, 2019 7:00 PM

Calea Victoriei 37B Sector 1, Bucharest, Romania, 010061

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)? This information day provides a platform for discussion about the status of the implementation and further compliance with the new Regulation, as well as the associated legislation in the region.

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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

Steffen Thirstrup, MD

Chief Medical Officer, European Medicines Agency, Netherlands

Clinical Trials Regulation Overview and the New Process

Speaker(s)

Massimiliano Sarra, PHD, MPH

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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