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Platform Technology Designation: Opportunities and Challenges for Implementation
Session Chair(s)
Andrea Doyle
GRA Head, Region North America, Global Advertising and Promotion
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Describe the key attributes of the proposed Platform Technology Designation Program as described by the anticipated FDA draft guidance; Discuss stakeholder perspectives about the new designation program; Describe anticipated opportunities and challenges related to its implementation.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
FDA, United States
Deputy Super Office Director, Office of Therapeutic Products, CBER
Panelist
Evdokia Korakianiti, PhD, MSc
European Medicines Agency, Netherlands
Head of Quality and Safety of Medicines
Panelist
Monica Veldman
Alliance for Regenerative Medicine, United States
Director, Global Regulatory Policy
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