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Responsible use of AI in Pharmacovigilance: Global Perspectives from CIOMS WG XIV
Session Chair(s)
Phil Tregunno
Deputy Director - Patient Safety Monitoring
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
The CIOMS Working Group XIV, presents consensus recommendations for the responsible use of AI in pharmacovigilance. Speakers will address principles of governance, transparency, robustness, fairness, and regulatory expectations using real examples.
Learning Objective : Recognize common principles in the development and use of AI to support pharmacovigilance operations with a focus on processing of individual case safety reports; Describe a practical framework for critically appraising of AI models and systems, with focus on risk based approaches, human oversight, validity and robustness, transparency, data privacy, fairness and equity and governance.
Speaker(s)
Panalist
Representative Invited
Health Canada, Canada
Principles and recommendations from CIOMS WG XIV
Niklas Noren, PHD, MSC
Uppsala Monitoring Centre (UMC) , Sweden
Chief Science Officer
Panelist
Elizabeth Anne MacEntee Pileggi, BSN, MBA
Johnson & Johnson, United States
Senior Director, Head of Global Case and Safety Data Management
Panelist
Walter Straus, DrMed, MD, MPH, FACP
Moderna, United States
Vice President, Safety and PV
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