Leveraging Real-World Evidence for Regulatory Use
The interest in real‐world evidence in a regulatory context is rapidly growing. Recent advances in data quality and experience with appropriate regulatory use cases are crucial steps towards effective use of RWE for regulatory decision-making.
This session will introduce a quality checklist for regulatory-grade RWE and will present recent applications of RWE for regulatory use cases. A key feature of this session is a moderated discussion among regulatory thought leaders from the FDA, life sciences and real-world data experts about the current and future use of regulatory-grade real-world evidence.
Rebecca Miksad, MD, MPH
Senior Medical Director, Research Oncology at Flatiron Health
Amy Abernethy, MD, PhD
Chief Medical Officer / Chief Scientific Officer & SVP - Oncology at Flatiron Health
Sean Khozin, MD, MPH
Associate Director, Oncology Center of Excellence at FDA
Mike Kelsh, PhD, MPH
Executive Director, Center for Observational Research at Amgen
Katherine Tsokas, JD
Regulatory Head of Regenerative Medicine & Advanced Therapy at Janssen
Director, Regenerative Medicine & Advanced Therapy Network at Johnson & Johnson