A Paediatric Investigation Plan is on the critical path to obtain market approval in Europe, even if the condition does not occur in children. A PIP must be agreed with regulators before submitting a Marketing Authorization Application. If PIP requirements can be waived or deferred under specific circumstances, the negotiation process takes up to a year.
In the US, a Paediatric Study Plan must be submitted not later than 60 after the end-of-phase 2 meeting. Such a requirement can also be waived or deferred. How does the PSP process compares with the EU PIP, and can both be coordinated?
The webinar covered:
- Understanding of PIP requirements
- Obstacles and approaches to successful PIP submission
- Regulatory assessors’ perspective
- PIP implications and timelines
- Comparison with US PSP
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