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CBER Town Hall: Innovation and Public Health Response
Session Chair(s)
Karen Midthun, MD
Principal, Drug and Biological Products
Greenleaf Health, United States
Join us for this unique opportunity that includes members from Center for Biologics Evaluation and Research’s (CBER) leadership for an overview of CBER’s regulatory programs, including efforts related to expedited review, regulatory science, and postmarketing surveillance. We will discuss how the Center has used expedited programs in response to public health issues and how it facilitates the development of innovative products. Attendees are welcome to submit questions to the panel by emailing annualmeetingprogram@diaglobal.org; subject line: CBER Town Hall Q/A.
Learning Objective : Summarize key issues discussed by CBER; Identify regulatory hot topics in biologics.
Speaker(s)
Panelist
Theresa M. Finn, PhD
FDA, United States
Associate Director for Regulatory Policy, OVRR, CBER
Panelist
Wilson W. Bryan, MD
Greenleaf Health, United States
Executive Vice President, Drug and Biological Products
Panelist
Steven A. Anderson, PhD
FDA, United States
Director, Office of Biostatistics and Epidemiology, CBER
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