Dr. Marie Bradley is a Senior Advisor for RWE in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER). Her responsibilities related to real-world evidence (RWE) include serving as lead for the Advancing Real-World Evidence Program, the Real-World Evidence Subcommittee, and a portfolio of RWE demonstration projects. She also evaluates complex RWE-related study protocols submitted to the FDA. Recently, she has been helping to drive Agency level RWE initiatives in the Office of the Commissioner. Dr. Bradley is an established advocate, speaker, and panelist across national and international platforms on RWE-related topics and participates extensively in external engagement. She is a pharmacoepidemiologist and a pharmacist with over 16 years of experience working in regulatory, government, and academic sectors in the U.S. and the UK, including 11 years at the FDA. Dr. Bradley has a doctorate in pharmacoepidemiology and a master’s in pharmacy from Queen’s University Belfast, as well as a Master of Science in public health degree from London School of Hygiene and Tropical Medicine.

About the Presentation

This presentation will explore how the FDA is using real-world data (data routinely collected in clinical practice) to generate real-world evidence (RWE) to inform regulatory decisions about the effectiveness and safety of medical products. The lecture will cover the evolution of this approach, highlight key activities of the FDA’s Real-World Evidence program, and showcase selected guidance documents and demonstration projects that are advancing how we evaluate medical products.

Learning Objectives

Describe how the FDA evaluates regulatory submission containing real-world evidence.
Summarize key messages from the FDA’s RWE guidance documents.
Explain how FDA-supported RWE demonstration projects have addressed gaps in knowledge to support medical product development.

To Register

Non-FDA employees must register in:

After MS Teams Webinar registration, you will receive a link via email to access the live webinar. You must log in with the username and password created when you registered. Please pre-register at least two days before the event to ensure you receive the access link and outlook invitation for the session.

For technical assistance please contact: Rakesh.Raghuwanshi@fda.hhs.gov

Continuing Education (CE) Credit

Participants wishing to obtain CE credit must first register for the Grand Rounds using the MS Teams Webinar Registration link above. As CE credit is being offered through the Johns Hopkins University School of Medicine, those wishing to obtain CE credit must create a user profile on the Hopkins Cloud CME platform. If you have never had a CME certificate/credits awarded and need a user profile created, please log onto https://hopkinscme.cloud-cme.com and click the “Sign Up Now” button. DO NOT create a new account if you have already received credit for Johns Hopkins CME activities at any time. Click on Forgot Password if you already have an email on file with the JHU OCME office. Instructions on how to claim the CE credit will be provided during the Grand Rounds presentation, but participants must already have a Hopkins Cloud CME user profile before the presentation.