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Learning By Doing: Regulatory Applications for Breakthrough Therapies
Session Chair(s)
M. Scott Furness, PhD
Deputy Director, Office of New Drug Products, OPQ, CDER
FDA, United States
This session will present and facilitate discussion on the opportunities and challenges associated with breakthrough therapies with an emphasis on the innovative approaches to consider for submission of chemistry, manufacturing and control information in breakthrough (or otherwise expedited) submissions.
Learning Objective : Explain breakthrough therapy designation; Describe the CMC challenges associated with these expedited submissions as well as the best practices and submission strategies for these designated drugs.
Speaker(s)
FDA Perspective
Suparna Wedam, MD
FDA, United States
Medical Officer, OHOP, OND, CDER
Industry Experience
John Groskoph, MBA
Pfizer Inc, United States
Executive Director, Global CMC
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Ways to register
Registration override should work.