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Designing and Implementing a Robust Pharmacovigilance System for Vaccines
Session Chair(s)
Sanjeev Miglani, MD
Founder and Director
AWINSA Life Sciences, United States
This session will provide insights into the distinct challenges in vaccine pharmacovigilance. Vaccine postmarketing surveillance is critical to mitigating risks, aiding in a response to vaccine safety concerns, and building public trust. The session will present the common need around the globe to manage public concerns about events related to vaccine safety. It will also discuss the differences in safety reporting requirements in vaccines in the US versus EU and the specific points to be taken into account in safety management and signal evaluation of vaccines both from the US and EU perspective.
Learning Objective : Discuss differences in safety reporting requirements in vaccines in the US versus EU; Recognize special considerations in safety management and signal evaluation of vaccines.
Speaker(s)
Special Safety Considerations in Vaccines: US Perspective
Sanjeev Miglani, MD
AWINSA Life Sciences, United States
Founder and Director
Active Vaccine Safety Surveillance in Low- and Middle-Income Countries
Walter Straus, DrMed, MD, MPH, FACP
Moderna, United States
Vice President, Safety and PV
GVP Module for Vaccine Pharmacovigilance
Seema Jaitly, DrMed
Sagittal Pharma Consulting Ltd, United Kingdom
Managing Director