How EMA & FDA are Shaping the Future of Real-World Evidence for Regulatory Decision-Making
- Explore how EMA and FDA are evolving their frameworks and reflection papers to define when and how Real-World Evidence can support INDs, BLAs, and marketing authorisations
- Review recent case examples where RWE successfully contributed to regulatory decisions and what made these datasets “regulatory-grade”
- Discuss how improved data access, standardisation, and global collaboration can help biopharma generate credible, fit-for-purpose evidence accepted by multiple regulators