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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
VP, Head of Regulatory Strategy, 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)
John Weiner, JD
Associate Director for Policy, Office of Combination Products, OCPP, OC, FDA, United States
FDA Update
Susan Neadle, MS
Principal Consultant and President, Combination Products Consulting Services LLC, United States
Panelist
Kate Gillespie, BSN, MBA
Senior Director, Global Product Vigilance and Post Market Reporting , Johnson & Johnson, United States
Panelist
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