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Session 2: Procedure for Initial Authorization and Substantial Modifications
Session Chair(s)
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)
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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