Webinar: Framework for FDA’s Real-World Evidence Program – Mar 15, 2019
Framework for FDA’s Real World Evidence Program
About this Webinar
As part of the 21st Century Cures Act, the FDA released a framework for our Real-World Evidence (RWE) program. The goal for this webinar is to inform the public of FDA’s effort to understand the utility of real-world data (RWD) to generate evidence for regulatory decisions.
At the end of this webinar, participants will be able to:
- Describe the main elements of FDA’s real-world evidence (RWE) Program.
- List FDA considerations for evaluating the use of real-world data to generate RWE for regulatory decisions.
- Explain program items the Agency plans to address in the RWE Program.
- Describe at least one demonstration project that will help inform the use of RWD and RWE.
Who Should Attend
Stakeholders working on RWD and RWE to include:
- Regulatory affairs professionals
- Clinical research organizations
- RWD Curators
Jacqueline Corrigan-Curay, J.D., M.D.
Office of Medical Policy
Center for Drug Evaluation and Research