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.

戻る Agenda

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)

Submission of application process

Stefan Strasser, MD

Head of Clinical Trials, Institute Surveillance, AGES, Austria

Reference Safety Information (RSI)

Massimiliano Sarra, PhD, MPH

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

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

Camelia Mihaescu

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