Module232025

07/05/2025

Paediatric Investigation Plan (PIP) Development

Michelle Blake, Associate Director and Senior Consultant, DLRC Ltd

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in Regulatory Affairs

1

Learning outcomes

• The requirements and timing of the initial PIP submission • PIP terminology and concepts • Compiling the PIP strategy • The key components of the PIP application • Similarities and differences in EU PIP content vs the US iPSP and UK PIP • IRIS considerations for the PIP submission

The Organisation for Professionals in Regulatory Affairs

PIP Development

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