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Session 3: Operational Hot Topic: Machine Learning/Artificial Intelligence in Pharmacovigilance
Session Chair(s)
Mariette Boerstoel-Streefland, MD, MBA, MS
Senior Vice President, Worldwide Safety Officer
Bristol-Myers Squibb Company, United States
Bruce Donzanti, PhD
PV Consultant
United States
The application of Machine Learning/Artificial Intelligence (ML/AI) to support drug safety activities is in its infancy but it will drastically change the way we manage the huge volumes of potential safety data. It will have a significant impact on how we use our resources, freeing up much of what is currently used for manual, transactional tasks. Perhaps more importantly, it will improve our ability to work with traditional and new data sources and to gain better insights faster from larger sets of data.
This session will provide a brief introduction on the need for new technologies to address the growing concerns around the ability to assess the ever-increasing volumes of data for valuable safety information, the applicability of ML/AI to address this concern, and will bring in perspectives from regulatory authorities, pharma industry, and a technology innovator, to conclude with a panel discussion on where we are going with the application of ML/AI in pharmacovigilance.
Speaker(s)
Speaker
Bruce Donzanti, PhD
United States
PV Consultant
New Kid on the Block: Machine Learning and Why it’s Important for Pharmacovigilance
Shaun Comfort, MD, MBA
Genentech, A Member of the Roche Group, United States
Principal Science Enablement Director
Machine Learning Use Cases
Elenee Argentinis, JD
IBM Watson Health, United States
Offering Management Leader
Machine Learning Use Cases
Shaun Comfort, MD, MBA
Genentech, A Member of the Roche Group, United States
Principal Science Enablement Director
Regulatory Perspective on Machine Learning in Pharmacovigilance
Robert Ball, MD, MPH, MSc
FDA, United States
Deputy Director, Office of Surveillance and Epidemiology, CDER
Speaker
Mick Foy
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Director of Delivery
Panel Discussion
All Session Speakers, United States