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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)
Stefan Strasser, MD
Head of Clinical Trials, Institute Surveillance, AGES, Austria
Submission of Application Dossier • Part I common scientific documents • Part II the national documents
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