FDA Grand Rounds – Advancing Real-World Evidence in FDA Regulatory Decision Making Thursday, December 11, 2025 12:00 p.m. - 1:00 p.m. ET

https://www.fda.gov/science-research/about-science-research-fda/fda-grand-rounds?utm_medium=email&utm_source=govdelivery Title: FDA Grand Rounds: Advancing Real-World Evidence in FDA Regulatory Decision Making (CE credit offered) Date: Thursday, December 11, 2025 Time: 12:00 pm - 1:00 pm ET Via webcast About the Speaker: Marie Bradley, PhD Senior Advisor for Real-World Evidence Office of Medical Policy Center for Drug Evaluation and Research 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. CE credit will be offered. For more event information and to register: https://www.fda.gov/grandrounds https://www.fda.gov/science-research/about-science-research-fda/fda-grand-rounds?utm_medium=email&utm_source=govdelivery