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Platform Technology Designation: Opportunities and Challenges for Implementation
Session Chair(s)
Andrea Doyle, MBA
Global Regulatory Affairs NA Head, Sanofi, United States
This forum will review the key components of the new FDA Platform Technologies Designation program. A panel of experts will provide their perspectives on the proposal and discuss opportunities and challenges related to its implementation.
Learning Objective : Describe the key attributes of the proposed Platform Technology Designation Program as described by the anticipated FDA draft guidance; Discuss stakeholder perspectives about the new designation program; Describe anticipated opportunities and challenges related to its implementation.
Speaker(s)
Panelist
Rachael Anatol
Deputy Super Office Director, Office of Therapeutic Products, CBER, FDA, United States
Panelist
Evdokia Korakianiti, PharmD
Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Panelist
Monica Veldman
Director, Global Regulatory Policy, Alliance for Regenerative Medicine, United States
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