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