Inside Clinical Translation Session 4: Regulatory Affairs and Compliance

​Session 4: Regulatory Affairs and Compliance

​Speaker: Jeff Yuan, PhD (VP, Regulatory Affairs and Drug Safety Operations, Roivant Sciences)

​Speaker: Amber Silva (Senior Director, Head of Clinical Operations, Roivant Sciences)

​This five-part series will be led by industry experts charting the clinical roadmap for innovative therapies—from lead optimization to NDA submission. Sessions will cover the critical considerations for entering the clinic, trial design, regulatory frameworks, executing successful trials, and what happens post-completion.

Our speakers will not only share actionable frameworks for navigating clinical development—they’ll offer candid insights from personal successes and failures along the way.