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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 2: Procedure for Initial Authorization and Substantial Modifications

Session Chair(s)

Massimiliano Sarra, PhD, MPH

Massimiliano Sarra, PhD, MPH

Permanent official and CTFG Secretary

Italian Medicine Agency (AIFA), Italy

Session 2: Procedure for Initial Authorization and Substantial Modifications

Speaker(s)

Stefan Strasser, MD

Submission of Application Dossier • Part I common scientific documents • Part II the national documents

Stefan Strasser, MD

AGES, Austria

Head of Clinical Trials, Institute Surveillance

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