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Boston Convention and Exhibition Center

24 jun 2018 1:00 p.m. - 24 jun 2018 4:30 p.m.

415 Summer Street, , Boston, MA 02210 , USA

#31: Machine Learning in Pharmacovigilance

Instructors

Linda  Belmont, MD

Linda Belmont, MD

Project Coordinator, Learning & Digital Solutions, DIA, United States

Shaun  Comfort, MD, MBA

Shaun Comfort, MD, MBA

Principal Science Enablement Director, Genentech, A Member of the Roche Group, United States

Dr. Comfort is a Principle Scientific Enablement Director for Roche in Science Enablement and Processes, leading innovation work supporting Pharmacovigilance. He is a Board Certified Neurologist with 20 years combined biopharma industry/regulatory experience. Dr. Comfort’s current work focuses on developing machine-learning models to evaluate Drug-Adverse Event causality and predict Project/Phase Probability of Success. Recently he published his first book focused on using mathematical estimation in healthcare: How Much Is that Cure in the Window? Simple Math Solutions for Complicated Problems in Biology, Medicine, and Healthcare.

Bruce  Donzanti, PhD

Bruce Donzanti, PhD

PV Consultant, United States

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 in academia. He continued his research in industry before moving over to clinical development and eventually Medical Affairs. Bruce has held various positions in industry, including Head of Drug Safety at Genentech and now Senior Group Director of Pharmacovigilance Innovation Policy in Global Regulatory Affairs. In this role, Bruce focuses on current challenges in pharmacovigilance, such as predictive drug safety and quality of safety data sources.

Mick  Foy

Mick Foy

Director of Delivery, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Mick Foy has been with the MHRA for more than 35 years, he is a member of the MHRA’s Executive Committee and has recently been appointed Director of Delivery . Amongst his responsibilities is to drive initiatives to introduce new and improved services to stakeholders. Mick is SRO for the SafetyConnect and RegulatoryConnect programmes. He also leads MHRA efforts to build PV capabilities in other countries particularly low and middle income countries as part of a global initiative with the Bill and Melinda Gates Foundation.

Robert  Ball, MD, MPH, MSc

Robert Ball, MD, MPH, MSc

Deputy Director, Office of Surveillance and Epidemiology, CDER, FDA, United States

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 and biologic product safety and effectiveness using Real World Evidence, including managing the Sentinel System.

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