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Next Generation of Combination Products: Insights from the FDA Office of Combination Products and Industry Expert Application
Session Chair(s)
James Wabby, MHS
Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
AbbVie, United States
This forum will present FDA regulatory insights and discuss examples of current trends in the space of combination products. A panel of FDA representatives will provide updates on FDA policy and industry experts will share practices on application.
Learning Objective : Discuss and analyze the latest FDA regulatory expectations and challenges; Recognize current topics the FDA is observing and what industry should continue to do and what is causing challenging circumstances.
Speaker(s)
FDA Update
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC
Panelist
Susan Neadle, MS
Combination Products Consulting Services LLC, United States
Principal Consultant and President
Panelist
Kate Gillespie, BSN, MBA
Johnson & Johnson, United States
Senior Director, Global Product Vigilance and Post Market Reporting
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