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 3: Procedure for Initial Authorization and Substantial Modifications

Session Chair(s)

Vladimir Vujovic, MPHARM

Director, Clinical Trials Regulatory, IQVIA, Serbia

Procedure for Initial Authorization and Substantial Modifications

Speaker(s)

Stefan Strasser, MD

Head of Clinical Trials, Institute Surveillance, AGES, Austria

Submission of application process

Massimiliano Sarra, PHD, MPH

Permanent official and CTFG Secretary, Italian Medicine Agency (AIFA), Italy

Reference Safety Information (RSI)

Camelia Mihaescu

GCP, GLP and PhV Inspections, European Medicines Agency, Netherlands

New Process for Clinical Trial Registration and EU Clinical Trial Number Application

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