Cheng Chang

Company: Pfizer

Job title: Director, Clinical Pharmacology

Seminars:

Optimizing Pediatric Formulation Development Strategy Using MIDD: ~ A Case Study in Aligning the Regulatory Approval Path Without a Pediatric Trial 2:00 pm

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 Read more

day: Day 1