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Real-World Data Webinar Series:

Assessing Registries to Support Regulatory
Decision-Making for Drug and Biological Products
(Guidance for Industry)

1:00 PM – 2:00 PM ET

Speakers

John Concato, MD, MPH, MS
Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA

Kerry Jo Lee, MD
Associate Director for Rare Diseases, Rare Diseases Team, Division of Rare Diseases and Medical
Genetics, OND, CDER, FDA

Ansalan Stewart, PhD
Health Science Policy Analyst, Division of Clinical Trial Quality, OMP, CDER, FDA

Moderator

Susan C. Winckler, RPh, Esq.
CEO, Reagan-Udall Foundation for the FDA