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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

Session Chair(s)

James Wabby, MHS

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)

John Barlow Weiner, JD

FDA Update

John Barlow Weiner, JD

  • Associate Director for Policy, Office of Combination Products, OCPP, OC
  • FDA, United States
Susan W. Neadle, MS, MSc

Panelist

Susan W. Neadle, MS, MSc

  • Medical Device, Combination Products, Design Thinking, Process Excellence
  • and Program Management Expert, United States
Kate Gillespie, BSN, MBA

Panelist

Kate Gillespie, BSN, MBA

  • Senior Director, Global Product Vigilance and Post Market Reporting
  • Johnson & Johnson, United States