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Session 3: Procedure for Initial Authorization and Substantial Modifications
Session Chair(s)
Vladimir Vujovic, MPharm
Director, Regulatory Affairs
IQVIA, Serbia
Procedure for Initial Authorization and Substantial Modifications
Speaker(s)
Submission of application process
Stefan Strasser, MD
AGES, Austria
Head of Clinical Trials, Institute Surveillance
Reference Safety Information (RSI)
Massimiliano Sarra, PhD, MPH
Italian Medicine Agency (AIFA), Italy
Permanent official and CTFG Secretary
New Process for Clinical Trial Registration and EU Clinical Trial Number Application
Camelia Mihaescu
European Medicines Agency, Netherlands
GCP, GLP and PhV Inspections
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