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Wednesday, June 22 • 1:45pm - 2:45pm
#340: Monitoring COVID-19 Vaccine Safety

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-620-L04-P ; CME 1.00; RN 1.00

In response to the rollout of COVID-19 vaccines, governments around the world launched an unprecedented vaccine safety monitoring program. Using active and passive surveillance systems, these programs monitored multiple potential adverse events in near real time. This session will describe some of those programs and discuss future methods development for vaccine safety monitoring.

Learning Objectives

Describe the purpose of the FDA’s Biologics Evaluation and Effectiveness (BEST) Initiative; Describe the key findings of EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance).

Chair

Richard Forshee, PhD

Speaker

Moderator
Meredith Smith, PhD, MPA, FISPE

FDA's Post-Market Activities
Azadeh Shoaibi, MHS, PhD, MS

Academic Update
Marc A. Suchard, MD, PhD


Speakers
avatar for Richard Forshee

Richard Forshee

Deputy Director, OBPV CBER, FDA, United States
Richard Forshee is the Deputy Director for the Office of Biostatistics and Pharmacovigilance in the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration. He works on a wide range of issues related to the risks and benefits of blood and blood products... Read More →
avatar for Azadeh Shoaibi

Azadeh Shoaibi

Associate Director Post-Market Surveillance, OBPV,CBER, FDA, United States
Azadeh Shoaibi, PhD, MHS is the Associate Director for Post-market Surveillance at the FDA Center for Biologics Evaluation and Research (CBER) where she leads the Biologics Effectiveness and Safety (BEST) Initiative which conducts post-market surveillance activities of biologic products... Read More →
avatar for Meredith Smith

Meredith Smith

Sr Director, Risk Management, Global Patient Safety, Alexion Astra Zeneca Rare Disease, United States
Meredith Smith is Risk Management Director at AstraZeneca where she is responsible for medicinal product benefit-risk management for the Alexion Rare Disease Business Unit portfolio. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →
MS

Marc Suchard

Professor, UCLA Fielding School of Public Health, United States
Marc Suchard is helping to develop the nascent field of evolutionary medicine. This field harnesses the power of methods and theory from evolutionary biology to advance our understanding of human disease processes. Just as phylogenetic approaches have stimulated the field of evolution... Read More →

Wednesday June 22, 2022 1:45pm - 2:45pm CDT
Room 178 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  01: ClinSafety-PV, Session