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DIA 2021 Global Annual Meeting
COVID-19 Vaccines: Regulatory Strategies for Public Health Emergencies
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.
Peter W. Marks, MD, PhD
- Director, Center for Biologics Evaluation and Research
- FDA, United States
Donna Boyce, RAC
- Vice President, Global Regulatory Affairs, Vaccines
- Pfizer Inc, United States
Charbel Haber, PhD, MBA, MPH
- Senior Vice President, Head of Regulatory Affairs
- Moderna, United States
Mary Plank, MBA
- Executive Regulatory Science Director, BioPharmaceuticals R&D
- AstraZeneca, United States
Nancy Cauwenberghs, PhD
- Head, Global Regulatory Affairs Vaccines
- Janssen R&D, Belgium