Webinar: Framework for FDA’s Real-World Evidence Program – Mar 15, 201 (original) (raw)

Slides

_Framework for FDA’s Real World Evidence Progra_m

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.

Learning Objectives

At the end of this webinar, participants will be able to:

1. Describe the main elements of FDA’s real-world evidence (RWE) Program.
2. List FDA considerations for evaluating the use of real-world data to generate RWE for regulatory decisions.
3. Explain program items the Agency plans to address in the RWE Program.
4. 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
• Academia
• Clinical research organizations
• RWD Curators

FDA Speaker

Jacqueline Corrigan-Curay, J.D., M.D.
Director
Office of Medical Policy
Center for Drug Evaluation and Research
FDA