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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)
Peter Marks, MD, PHD
Senior Vice President, Molecule Discovery and Head of Infectious Disease, Eli Lilly and Company, United States
Panelist
Donna Boyce, MS, RAC
Senior Vice President & Head, Global Regulatory Sciences, Pfizer, United States
Panelist
Charbel Haber, PHD, MBA, MPH
Senior Vice President, Head of Regulatory Affairs, Moderna, United States
Panelist
Mary Plank, MBA
Executive Regulatory Science Director, BioPharmaceuticals R&D , AstraZeneca, United States
Panelist
Nancy Cauwenberghs, PHD
Head Global Labeling, GRA, J&J Innovative Medicines, Belgium
Panelist
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