The US Food and Drug Administration (FDA) and payers are increasingly using real-world evidence (RWE) to support key regulatory and market access decisions. In fact, real-world evidence can now be used throughout the product lifecycle to support regulatory approval, receive optimal positioning in formularies, and eventual label expansion. How can study sponsors achieve these goals in a timely and efficient way?
This webinar covers the following topics:
What recent activities has the FDA conducted around RWE?
What aspects of the FDA’s RWE guidance are most relevant for study sponsors?
How can RWE be used during the pre-, peri-, and post-approval phases of product development?
Do RWE use cases differ for regulatory and payer submissions?
How can RWE be integrated into my clinical trial program?
What common pitfalls should be avoided when using RWE for these activities?
What is the current status of the Inflation Reduction Act in the US?
Date: 21st May 2025
Time: 10am ET | 3pm BST | 4pm CEST
Speakers
