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

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

Credits: None available.

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, MBA, PE, Consumer Safety Officer, Office of Pharmaceutical Quality, FDA/CDER
Lynn Lundy, Sr. Director, Regulatory Affairs, West Pharmaceutical Services
Susan W. Neadle, FRAPS, FAAO, 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.

You must be logged in and own this session in order to post comments.