Current Status of RWD/E Use in Regulatory Decision Making: Lessons Learned, Ongoing Challenges, and Future Directions

• Review FDA use cases where RWE has supported regulatory submissions and decisions
• Explore therapeutic-area differences in feasibility, fit-for-purpose data, and evidentiary expectations
• Discuss key challenges, lower hanging opportunities, and future directions for RWD/E in regulatory decision-making

Speakers:

Amit Raval

Director, Real World Evidence Oncology

Bayer