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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

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

Panelist(s):

Speaker(s):

Panelist(s):

  • Mike Wallenstein, Novartis Global Head MDR Implementation & DD&C Compliance, Novartis Pharma AG

Speaker(s):

  • Joerg Zimmermann, Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co.

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