Research

REGULATORY & POLICY

1:00 – 2:00PM EST

Live Q&A

Industry experience in applying RWE to support regulatory decisions has significantly expanded over the past year as the inclusion of RWE in regulatory submissions increased. Feedback stemming from regulator review of submissions leveraging RWD serves as a valuable opportunity to understand how RWD is considered and reviewed in the regulatory context. This session will be an open dialogue between the FDA and biopharma partners to share successes and address concerns in incorporating RWE in regulatory submissions.