CRED 8 Presentations

01/07/2024

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)

The Organisation for Professionals in Regulatory Affairs 47

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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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The Organisation for Professionals in Regulatory Affairs

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