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Overview

This course will provide a full introduction to PIPs and the EU Paediatric Regulation. The course faculty are European-based leading experts from EMA and industry.

Topics will be presented through interactive lectures and hands-on workshop training. Overview of the Paediatric Investigation Plan (PIP) procedure and lifecycle, including in-depth discussion of specific scientific/regulatory issues in relation to PIPs will be discussed. Case-studies and instructor-led group work on specific cases will be presented.