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Combination Products - Part 2: Evolving Global Regulations: Health Authority Perspective


Nov 6, 2020 9:00am ‐ Nov 6, 2020 10:30am



Credits: None available.

Description

Combination Products - Part 2: Evolving Global Regulations: Health Authority Perspective | US FDA has continued to evolve the regulatory space for combination products in the United States, EU MDR implementation is upcoming. Efforts to align definitions are underway through ASTM International. In this session we will get health authorities perspectives on the dynamic combination products regulatory space, what's working, what's challenging, what's next.

Speaker(s):

  • CAPT. Melissa B. Burns, Senior Program Manager, Office of Combination Products, FDA/CDER
  • Stephanie Goebel, Senior Consultant, Beyond Conception GmbH
  • Steven Hertz, MS, MBA, PE, Consumer Safety Officer, Office of Pharmaceutical Quality, CDER/FDA
  • Lynn Lundy, Sr. Director, Regulatory Affairs, West Pharmaceutical Services
  • Susan W. Neadle, FAAO, FBCLA, President, Combination Products Consulting Services LLC
  • Tobias Nemeth, Director Primary Packaging Service & Projects, Vetter Development Services
  • Kirsten Paulson, Sr. Director, Global CMC-Medical Devices, Pfizer, Inc.
  • Jonathan Sutch, Tech Specialist & Scheme Manager - Med & Bio, BSI
  • Mike Wallenstein, Novartis Global Head MDR Implementation & DD&C Compliance, Novartis Pharma AG

Credits

Credits: None available.

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