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Overview of the Paediatric Investigation Plan (PIP) procedure, including in-depth discussion of specific scientific/regulatory issues in relation to PIPs, case-studies and instructor-led group work on specific cases.

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.

Key Topics

  • EU paediatric regulation
  • PIP lifecycle
  • How to get your PIP approved
  • PIPs after approval