Module232025

07/05/2025

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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PIP: Strategy for development in children 0 - < 18 years

Quality Non-clinical aspects Clinical aspects PIP proposes measures to obtain a paediatric indication in all subsets Marketing Authorisation criteria

Planned studies:

- study outlines - timelines

The PIP ● Is to be agreed upon and/or amended by the PDCO ● Is bindingon company

The Organisation for Professionals in Regulatory Affairs

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