Menu Back toInstructors

#31: Machine Learning in Pharmacovigilance


  • Shaun  Comfort, MD, MBA

    Shaun Comfort, MD, MBA

    • Associate Director and Senior Safety Science Leader IIDO
    • Genentech, A Member of the Roche Group, United States

    Dr. Comfort is Associate Director for Risk Management and Sr. Safety Science Leader for Roche-GNE Late Stage Ophthalmology/Hematology Products. He is a Board Certified Neurologist with 13 years combined industry experience including roles as former Medical Reviewer at the US FDA and VP of Clinical Research at Anesiva. Most recently, he has been involved in evaluating Artificial Intelligence solutions in Pharmacovigilance.

  • Bruce  Donzanti, PhD

    Bruce Donzanti, PhD

    • Senior Group Director, Global Pharmacovigilance Innovation Policy
    • Genentech, A Member of the Roche Group, United States

    Bruce has a PhD in pharmacology with 20+ years experience in the pharma/bio industry, mostly in drug safety but he has also worked in other areas such as pre-clinical research. During the past 5 years, Bruce was Head, Drug Safety at Genentech before transitioning into a new role in that focuses on proactive ways to enhance drug safety as well as addressing current challenges. Bruce is also the current Chair of the Pharmacovigilance/Benefit Risk Working Group at BIO.

  • Mick  Foy

    Mick Foy

    • Head of Pharmacovigilance Strategy, Vigilance Intelligence and Research Group
    • MHRA, United Kingdom

    Mick has been with the MHRA’s Vigilance Intelligence and Research Group for 11 years. Amongst his responsibilities is the operation of the UK’s Yellow Card Scheme and the signal detection system. He is responsible for two major projects to improve drug safety. Firstly a Gates Foundation funded project to build PV capacity in low and middle income countries and the IMI funded WEB-RADR project to deliver mobile Apps for reporting ADRs and to utilise social media for drug safety purposes.

  • Robert  Ball, MD, MPH

    Robert Ball, MD, MPH

    • 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 risks and promoting the safe use of drugs by the American people, including managing the Sentinel System. Dr. Ball’s research interests lie at the interface of clinical medicine, epidemiology, and computational science. His recent research has concentrated on the application of computational and informatics approaches, including natural language processing and machine learning, to improve the evaluation of medical product safety in electronic health data systems.

Contact us

Registration Questions?

Send Email