CRED ERP 25
01/07/2025
Main pillars Paediatric Regulation
• An expert committee: the Paediatric Committee ( PDCO )
• An agreed (evolving) paediatric development: the Paediatric Investigation Plan ( PIP ) • A system of obligations and rewards (e.g. ‘patent’ extension, free scientific advise)
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Paediatric Investigation Plan (1/2)
⚫ Paediatric investigation plan (PIP) – a development plan aimed at ensuring that the necessary data are obtained to support the authorisation for children of new medicines or new indication, pharmaceutical form or route of administration
- Should be submitted around end of Phase I studies
- Outlines timing and measures to be undertaken
- Deferral or waiver possible, if applicable
- Modifications possible
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