Module232025

07/05/2025

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

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Once you have an approved PIP, you need to follow it strictly!

Fulfil all measures in PIP Decision Include new developments

● Changes are addressed through modification of PIP

What happens if you don ´ t?

The Organisation for Professionals in Regulatory Affairs

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