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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, Patient Safety Officer , Bristol Myers Squibb, 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)
Bruce Donzanti, PHD
PV Consultant, United States
Speaker
Shaun Comfort, MD, MBA
Principal Science Enablement Director, Genentech, A Member of the Roche Group, United States
New Kid on the Block: Machine Learning and Why it’s Important for Pharmacovigilance
Elenee Argentinis, JD
Offering Management Leader , IBM Watson Health, United States
Machine Learning Use Cases
Shaun Comfort, MD, MBA
Principal Science Enablement Director, Genentech, A Member of the Roche Group, United States
Machine Learning Use Cases
Robert Ball, MD, MPH, MSC
Deputy Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Regulatory Perspective on Machine Learning in Pharmacovigilance
Mick Foy
Director of Delivery, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Speaker
Panel Discussion
, All Session Speakers, United States
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