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Omni Shoreham Hotel

22 ene 2018 7:00 a.m. - 24 ene 2018 5:00 p.m.

2500 Calvert Street NW, , Washington, DC 20008 , USA

Pharmacovigilance and Risk Management Strategies Conference

Session 3: Operational Hot Topic: Machine Learning/Artificial Intelligence in Pharmacovigilance

Session Chair(s)

Mariette  Boerstoel-Streefland, MD, MBA, MS

Mariette Boerstoel-Streefland, MD, MBA, MS

Senior Vice President, Worldwide Safety Officer

Bristol-Myers Squibb Company, United States

Bruce  Donzanti, PhD

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

Speaker

Bruce Donzanti, PhD

United States

PV Consultant

Shaun  Comfort, MD, MBA

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

Elenee  Argentinis, JD

Machine Learning Use Cases

Elenee Argentinis, JD

IBM Watson Health, United States

Offering Management Leader

Shaun  Comfort, MD, MBA

Machine Learning Use Cases

Shaun Comfort, MD, MBA

Genentech, A Member of the Roche Group, United States

Principal Science Enablement Director

Robert  Ball, MD, MPH, MSc

Regulatory Perspective on Machine Learning in Pharmacovigilance

Robert Ball, MD, MPH, MSc

FDA, United States

Deputy Director, Office of Surveillance and Epidemiology, CDER

Mick  Foy

Speaker

Mick Foy

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

Director of Delivery

  Panel Discussion

Panel Discussion

All Session Speakers, United States

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