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COVID-19 Vaccines: Regulatory Strategies for Public Health Emergencies
Session Chair(s)
Jesse L. Goodman, MD, MPH
Director, Center on Medical Product Access, Safety and Stewardship (COMPASS)
Georgetown University, United States
This forum will focus on novel regulatory challenges for developing COVID-19 vaccines. The panel will focus on regulatory strategies and evidentiary criteria needed for the FDA EUA and BLA pathways.
Learning Objective : Describe FDA’s Emergency Use Authorization regulatory pathway; Discuss how COVID-19 vaccine manufactures developed their regulatory strategies with respect to EUA and BLA; Identify considerations for developing vaccines for future public health emergencies.
Speaker(s)
Panelist
Peter W. Marks, MD, PhD
FDA, United States
Director, Center for Biologics Evaluation and Research
Panelist
Donna Boyce, MS, RAC
Pfizer Inc, United States
Head and Senior Vice President of Global Regulatory Sciences
Panelist
Charbel Haber, PhD, MBA, MPH
Moderna, United States
Senior Vice President, Head of Regulatory Affairs
Panelist
Mary Plank, MBA
AstraZeneca, United States
Executive Regulatory Science Director, BioPharmaceuticals R&D
Panelist
Nancy Cauwenberghs, PhD
J&J Innovative Medicines, Belgium
Head Global Labeling, GRA
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