Module232025

07/05/2025

Articles 17, 18 & 19

Paediatric Investigation Plan

• These articles set out timelines for review and PDCO opinion…

• …including mid-review clock-stop provisions…

• …with further reinforcement of PDCO’s right to impose waivers

You will get a lot more information on review timelines and procedures from other lectures

The Organisation for Professionals in Regulatory Affairs

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Articles 20 & 21

Paediatric Investigation Plan

“Deferral” means “will occur after submission of the initial MAA”

Deferrals for initiation and completion of PIP commitments are independent

Yes and no…

…only when PDCO agrees It’s not enough for the applicant to think this

This has never happened

The Organisation for Professionals in Regulatory Affairs

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