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Strategies to Implement Routine Intelligent Automation Technologies within Pharmacovigilance for the ICSR Process
Session Chair(s)
Raymond Kassekert, MBA
Senior Director PV Systems
GSK, United States
Intelligent automation can transform the ICSR process. We discuss how this technology may be implemented and validated to ensure solutions are fit for purpose.
Learning Objective : • Understand PV automation technologies that exist and determine which ICSR process steps are ripe for automation • Understand the effort, risks, and benefits of using intelligent automation for specific process steps within ICSR • Learn which ICSR technologies are being planned, piloted, or are in production, and understand key considerations for validation
Speaker(s)
AI in Pharmacovigilance Case Processing – An MHRA Pharmacovigilance Inspector’s Perspective
Dominic Nguyen-Van-Tam, PHD, MSC
Medicines and Healthcare Products Regulatory Agency, United Kingdom
Senior GPvP Inspector
Title to be Announced
Luisa Fernanda Barrios, DrMed
Merck & Co., Inc., Colombia
CSRM Executive Director