Module232025

07/05/2025

• No processing of Variation application is possible until Compliance Check of finalised PIP studies is performed • Be aware of the time between LPLV and final CSR and the following Compliance Check • Follow up with EMA Paediatric coordinator

Case study – project´s learnings

The Organisation for Professionals in Regulatory Affairs

57

Agenda

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

The Organisation for Professionals in Regulatory Affairs

58