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DIA 2021 Global Annual Meeting


COVID-19 Vaccines: Regulatory Strategies for Public Health Emergencies

Session Chair(s)

Jesse L. Goodman, MD, MPH

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 W. Marks, MD, PhD

Panelist

Peter W. Marks, MD, PhD

  • Director, Center for Biologics Evaluation and Research
  • FDA, United States
Donna  Boyce, RAC

Panelist

Donna Boyce, RAC

  • Vice President, Global Regulatory Affairs, Vaccines
  • Pfizer Inc, United States
Charbel  Haber, PhD, MBA, MPH

Panelist

Charbel Haber, PhD, MBA, MPH

  • Senior Vice President, Head of Regulatory Affairs
  • Moderna, United States
Mary  Plank, MBA

Panelist

Mary Plank, MBA

  • Executive Regulatory Science Director, BioPharmaceuticals R&D
  • AstraZeneca, United States
Nancy  Cauwenberghs, PhD

Panelist

Nancy Cauwenberghs, PhD

  • Head, Global Regulatory Affairs Vaccines
  • Janssen R&D, Belgium