Optimizing Pediatric Formulation Development Strategy Using MIDD: ~ A Case Study in Aligning the Regulatory Approval Path Without a Pediatric Trial
Time: 2:00 pm
day: Day 1
Details:
- Hear real-world insights from the strategy lead behind successful regulatory interactions using MIDD to reduce or eliminate clinical studies, particularly in pediatric programs
- Discover how purpose-fit modeling tools were applied to align both FDA and EMA expectations
- Understand the challenges and successes in navigating complex regulatory landscapes, and how persistence helped secure regulatory alignment
