Back to Agenda
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
Founder and Director, AWINSA Life Sciences, United States
Active Vaccine Safety Surveillance in Low- and Middle-Income Countries
Vice President, Safety and PV, Moderna, United States
GVP Module for Vaccine Pharmacovigilance
Managing Director, Sagittal Pharma Consulting Ltd, United Kingdom
Have an account?