Module232025

07/05/2025

The PIP Procedure Mette Due Theilade Thomsen mt@pipadviser.com

The Organisation for Professionals in Regulatory Affairs

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Agenda

 GMA and implications for PIP Procedures  Scope of PIP  PIP approval  PIP opinion  PIP modification, Stepwise PIP  Compliance check  Paediatric scientific advice  PDCO PIP assessment, recurring issues

The Organisation for Professionals in Regulatory Affairs

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