Spring Intro 2023

16/02/2023

Consideration & tips

Compliance check: ● Partial ● Full (including all deferred measures) Content of annual report: ● Is overall paediatric development continuing as planned?  If not, why?

● Comment on individual measures incl. timelines ● Is there intent to submit a PIP modification? Modifications ● Plan timings, are there any measures that can be modified/closed out earlier/together? ● Better to approach PDCO earlier if a change to study design is needed

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Top Tips

● Maintain compliance to avoid the EMA ‘name and shame’ list. Published annually outlines all companies who did not:  Submit PIP on time (no later than end of human PK studies)  Complied with PIP measures  Submitted annual report When to submit PIP annual report: ● Only required after MAA is granted, prior to 1 st anniversary ● Keep on top of agreed measures – annual report good opportunity to check in with team to see if any measures can be closed out or if modifications are required.

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