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Wednesday, June 30 • 4:00pm - 5:00pm
#358 L: COVID-19 Vaccines: Regulatory Strategies for Public Health Emergencies

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-632-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Jesse L. Goodman, MD, MPH

Speaker

Panelist
Peter W. Marks, MD, PhD

Panelist
Donna Boyce, RAC

Panelist
Charbel Haber, PhD, MBA, MPH

Panelist
Mary Plank, MBA

Panelist
Nancy Cauwenberghs, PhD



Speakers
avatar for Peter Marks

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA, United States
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →
DB

Donna Boyce

Vice President, Global Regulatory Affairs, Vaccines, Pfizer Inc, United States
avatar for Nancy Cauwenberghs

Nancy Cauwenberghs

Head, Global Regulatory Affairs Vaccines, Janssen R&D, Belgium
Nancy is heading up the Global Regulatory Affairs organization for vaccines, within Janssen Vaccines, J&J, since 2019. Prior to this assignment, Nancy was Sn Director Regulatory Affairs, Vaccines at MSD (Merck Inc). During this period Nancy also contributed to many vaccine policy... Read More →
JG

Jesse Goodman

Director, Center on Medical Product Access, Safety and Stewardship (COMPASS), Georgetown University, United States
Jesse L. Goodman, M.D., M.P.H. is Professor of Medicine at Georgetown University, where he directs the Center on Medical Product Access, Safety and Stewardship focused on informing science based policy to address emerging public health needs, including product development and access... Read More →
avatar for Charbel Haber

Charbel Haber

Senior Vice President, Head of Regulatory Affairs, Moderna, United States
Charbel Haber joined Moderna in April 2020 as a Senior Vice-President of Regulatory Affairs. In this role, Charbel is responsible of building a global regulatory organization, comprising, Regulatory Operations, Regulatory CMC, and Regulatory Strategy, to support Moderna’s pipeline... Read More →
avatar for Mary Plank

Mary Plank

Executive Regulatory Science Director, BioPharmaceuticals R&D, AstraZeneca, United States
A regulatory professional with more than 35 years of industry experience. Experience includes work with a number of global and regional health authorities including FDA, EMA, MHRA, PEI, PMDA, Health Canada, TGA and WHO for the development and authorization of COVID-19 vaccines and... Read More →


Wednesday June 30, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum