Module232025

07/05/2025

NEW version of PIP scientific document

Graphs for development Leaner structure overall

New features

Embed extrapolation Updated modelling and simulation section Feedback from other regulators Input from experts

New aspects reflected

Fully revised formulation and non-clinical sections

Facilitates assessment and input from working parties/working groups

More rational waiver section

Commenting streamlined

The Organisation for Professionals in Regulatory Affairs

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Typical PIP validation issues

Section 2 :  Lack of information on maturation parameters affecting PK/PD in different age subsets  Insufficient paediatric incidence/prevalence data - all age groups, European and worldwide Section 3:  Build up PIP by combination of development plan and waiver Section 4:  Detailed information including justification needed on the clinical trial design  M&S, extrapolation concept and plan not sufficiently described  Include study synopses for all studies – also quality, nonclinical, M&S – and in KEF  Do not write ”TBD”!

The Organisation for Professionals in Regulatory Affairs

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