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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
Michael Forstner, PhD, MPH, MSc
Mesa Laubela-Consulting, Switzerland
Managing Director, Head of Pharmacoepidemiology Practice
Regulator Observations and Feedback
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
Advancing Safety Analytics
Paul Chang, MD
Janssen Pharmaceuticals, United States
Chief Safety Officer
Intelligent Automation in Pharmacovigilance
Songlin Xue, MD, PhD
Astellas, United States
Executive Vice President and Global Head of Pharmacovigilance
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