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DIA 2021 Global Annual Meeting
Next Generation of Combination Products: Insights from the FDA Office of Combination Products and Industry Expert Application
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.
John Barlow Weiner, JD
- Associate Director for Policy, Office of Combination Products, OCPP, OC
- FDA, United States
Susan W. Neadle, MS, MSc
- Medical Device, Combination Products, Design Thinking, Process Excellence
- and Program Management Expert, United States
Kate Gillespie, BSN, MBA
- Senior Director, Global Product Vigilance and Post Market Reporting
- Johnson & Johnson, United States