What is a Pediatric Investigation Plan (PIP) and when should we plan for it in Europe?

Access decades of experience

Mandatory PIP Timeline Requirements

Critical timing differences between EU and US pediatric planning. Why late Phase 1 submission is essential in Europe.

Legal Obligations vs. US System

How Europe's PIP requirements differ from US PREA rules, including scope that catch US companies off-guard.

Market Exclusivity Incentives

The rewards system for completing PIP obligations and how it differs between orphan and non-orphan drug classifications.

Implementation Planning

Operational considerations for pediatric studies and alignment with adult development timelines.