Module232025

07/05/2025

What happens with an agreed PIP? PDCO adopts the PIP opinion. One month later, EMAs executive director signs it,

and it then becomes the binding PIP decision. EMA PIP decisions published on EMA Website Not published: ● Details on individual studies/measures

European database of all clinical trials (EudraCT/CTIS) ● Protocol and results related information for all paediatric studies to be public, usually at time of clinical trial application Mandatory inclusion of paediatric information in Product Information ● (To be eligible for reward)

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  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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