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2020 ISPE Annual Meeting & Expo


SES405 - Combination Products Part 2: Evolving Global Regulations: Health Authority Perspective


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

Expiration Date: Nov 30, 2021

Description

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.

Session Leader(s):

  • Susan W. Neadle, FAAO, FBCLA, Sr. Director, Global Value Chain Quality Design, Johnson & Johnson

Speaker(s):

  • CAPT. Melissa B. Burns, PhD, Senior Program Manager, Office of Combination Products, FDA/CDER
  • Stephanie Goebel, Dipl Ing (FH), Senior Consultant, Beyond Conception GmbH
  • Steven Hertz, MS, MBA, PE, Consumer Safety Officer, FDA/CDER/OPQ
  • Lynn Lundy, MS, MBA, RAC, Sr. Director, Regulatory Affairs, West Pharmaceutical Services
  • Jonathan Sutch, Tech Specialist & Scheme Manager - Med & Bio, BSI
  • Jörg Zimmermann, Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co.

Panelist(s):

  • Tobias Nemeth, Director, Vetter Development Services
  • Kirsten Paulson, MS, RAC, Sr. Director, Global Regulatory CMC-Medical Devices, Pfizer Inc.
  • Mike Wallenstein, Novartis Global Head MDR Implementation & DD&C Compliance, Novartis Pharma AG

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