Sarah Alummootil
Director Early Access Programs Early Access Care
Seminars
Wednesday 25th March 2026
When Access Creates Evidence: Real‑World Data from Expanded Access Programs
10:00 am
- Real‑world evidence generated through these programs that has informed regulatory decision‑making, contributing to EMA scientific advice discussions and, in specific cases, resulted in FDA labeling indications and marketing authorizations
- This session will focus on the types of approaches and real regulatory results
