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Session 1 Introduction of GRM

Session 2 Planning of Application

Session 3 Preparation of Application Dossier

Session 4 Managing and Conducting the Review

Session 5 Using Facilitated Regulatory Pathways (FRPs) for Special Case Authorizations

Session 6 Communication

Session 7 Topic of Special Interest I: Orphan Drug Regulations

Session 8 Topic of Special Interest II: RWD/RWE for regulatory decision-making