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Updates and Lessons Learned from Novel Approaches to Pharmacovigilance Collaboration
Session Chair(s)
Jose Vega, MD
Chief Safety Officer , Moderna, United States
Following the initial success of an unprecedented collaboration between nineteen sponsors to address major pharmacovigilance challenges with regulators, this session will provide lessons learned and an update on an increasing scope of collaborative work. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Tuesday, June 25, 3:15-4:15PM in the DIA Community Zone 1, Sails Pavilion.
Learning Objective : Identify expert perspectives on the future of the field of clinical safety and pharmacovigilance, with a focus on trends, challenges, and how collaborations can work to advance the industry in this space; Discuss strategies to address pharmacovigilance challenges in the long-term.
Speaker(s)
The European IV Iron PASS Consortium: Experiences from Coordinating a Multi-Company, Multi-Registry PASS
Managing Director, Head of Pharmacoepidemiology Practice, Mesa Laubela-Consulting, Switzerland
Regulator Observations and Feedback
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Advancing Safety Analytics
Chief Safety Officer, Janssen Pharmaceuticals, United States
Intelligent Automation in Pharmacovigilance
Executive Vice President and Global Head of Pharmacovigilance, Astellas, United States
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