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From Conventional to Intelligent: Redefining Pharmacovigilance with AI and Global Collaboration
Session Chair(s)
Ju-Young Shin, PHD
Professor
School of Pharmacy, Sungkyunkwan University, Korea, Republic of
This session traces the evolution of PV innovation: from algorithms tailored to vulnerable groups, to FDA pilots applying AI at scale, to regulatory guidance ensuring readiness and global harmonization for next-generation safety systems.
Learning Objective : Identify algorithmic innovations that address signal detection challenges in vulnerable populations; Examine how AI is being piloted to extend these methods into large-scale pv workflows with transparency and oversight; Describe regulatory approaches that translate methodological and technological advances into practice through validation and international harmonization.
Speaker(s)
Recent advances in PV innovation: implementing/deploying for practical impact
Raymond Kassekert, MBA
GSK, United States
Executive Director, PV Systems Management
Strengthening National Pharmacovigilance Systems to Advance Drug Safety Monitoring
Representative Invited
Korea Institute of Drug Safety and Risk Management(KIDS), Korea, Republic of
A method for systematically retrieving pregnancy-related reports
Daniele Sartori, MSC
Uppsala Monitoring Centre (UMC), Sweden
Senior Pharmacovigilance Scientist
Panelist
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
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