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Content 1 : Opening Remarks

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 : Bringing Consistency and Efficiency to Regulatory Decision-Making

Session 6 : Communication

Session 7 : The Access Consortium New Active Substance working-sharing procedure – An Australian perspective

Session 8 : Considerations of the Application of RWD/RWE in Regulatory Decision-Making