Back to Agenda
Real World Evidence: How Does its Use Challenge Quality and Compliance Programs?
Session Chair(s)
Kassa Ayalew, MD, MPH
Director, DCCE, OSI, Office of Compliance, CDER
FDA, United States
Evaluation of real world evidence (RWD) in the context of regulatory decision making depends not only on the evaluation of the methodologies used to generate the evidence, but on the reliability and relevance of the underlying RWD. FDA uses on-site inspections and data audits to evaluate all aspects of the conduct and reporting of FDA regulated research including data derived in real world settings. Speakers will provide views from regulatory perspective.
Learning Objective : Discuss the importance of reliable data derived from sources other than traditional clinical trials to support regulatory decision making; Identify factors that FDA considers for assessing the reliability of real world data through on site inspections.
Speaker(s)
CPRD Update
Susan Beatty, MSc
The Clinical Practice Research Datalink Group (CPRD); MHRA, United Kingdom
Clinical Operations Manager
FDA Update
Ni Aye Khin, MD, MS
FDA, United States
Director, Division of Clinical Compliance Evaluation, OSI, OC, CDER
Industry Update
Jonathan Andrus, MS
CRIO, United States
President and Chief Operating Officer
Have an account?