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Tuesday, June 25 • 2:00pm - 3:15pm
#255: Pharma and Regulatory Perspectives on Machine Learning Applications in Pharmacovigilance

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-610-L04-P; CME 1.25; IACET 1.25; RN 1.25

Machine Learning is one approach in the fast-paced field of artificial intelligence that is positioned to address many key issues in pharmacovigilance. However, it presents several challenges which must be addressed by both industry and regulators. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Wednesday, June 26, 3:15-4:15PM in the DIA Community Zone 2, Sails Pavilion.

Learning Objectives

Review updated developments in machine learning in PV; Discuss risks and challenges; Describe updates on regulatory landscape and areas of future development and collaboration.


Bruce Donzanti, PhD


Chapter Two: Implementing Automation, Machine Learning, and Analytics in Pharmacovigilance - Case Study
Lisa George, RPh

FDA Perspective
Robert Ball, MD, MPH, MSc

MHRA Perspective
Mick Foy

avatar for Robert Ball

Robert Ball

Deputy Director, Office of Surveillance and Epidemiology, CDER, FDA
Robert Ball MD, MPH, ScM is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for leading OSE staff evaluating drug risks and promoting the safe use of drugs by the American... Read More →
avatar for Bruce Donzanti

Bruce Donzanti

Senior Group Director, Global Pharmacovigilance Innovation Policy, Genentech, A Member of the Roche Group
Bruce has a PhD in pharmacology/neuroscience with almost 30 years of experience in the pharma/biotech industry. Prior to industry, he performed research on mechanisms of neuronal degeneration and neurotoxicology and lectured in neuropharmacology to graduate and medical students while... Read More →
avatar for Mick Foy

Mick Foy

Head of Pharmacovigilance Strategy, Vigilance Intelligence, and Research Group, Medicines and Healthcare Products Regulatory Agency (MHRA)
Mick Foy is Head of Pharmacovigilance Strategy at the MHRA. Among is responsibilities is the running of the UK ADR reporting system and signal detection activities. Mick is also leads the MHRA's work with WHO and the Bill and Melinda Gates Foundation on capacity building in low and... Read More →
avatar for Lisa George

Lisa George

Advisor, Global Patient Safety, Case Management, Eli Lilly and Company
Lisa George has a B.S. in Pharmacy from Butler University, Indianapolis IN. Lisa started in the pharmaceutical industry in 1998 with Eli Lilly and Company's Global Patient Safety (GPS) department. During her time in GPS, she has worked with case management in various capacities. Lisa... Read More →

Tuesday June 25, 2019 2:00pm - 3:15pm
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA