Industry Perspective on Artificial Intelligence/Machine Learning in Pharmacovigilance.

Journal: Drug safety
Published Date:

Abstract

TransCelerate reports on the results of 2019, 2020, and 2021 member company (MC) surveys on the use of intelligent automation in pharmacovigilance processes. MCs increased the number and extent of implementation of intelligent automation solutions throughout Individual Case Safety Report (ICSR) processing, especially with rule-based automations such as robotic process automation, lookups, and workflows, moving from planning to piloting to implementation over the 3 survey years. Companies remain highly interested in other technologies such as machine learning (ML) and artificial intelligence, which can deliver a human-like interpretation of data and decision making rather than just automating tasks. Intelligent automation solutions are usually used in combination with more than one technology being used simultaneously for the same ICSR process step. Challenges to implementing intelligent automation solutions include finding/having appropriate training data for ML models and the need for harmonized regulatory guidance.

Authors

  • Raymond Kassekert
    GlaxoSmithKline, Global Safety, Upper Providence, PA, USA.
  • Neal Grabowski
    AbbVie, Pharmacovigilance and Patient Safety Business Process Office, North Chicago, IL, USA. neal.grabowski@abbvie.com.
  • Denny Lorenz
    Bayer AG, Medical Affairs and Pharmacovigilance, Pharmaceuticals, Berlin, Germany.
  • Claudia Schaffer
    Merck Healthcare, Case and Vendor Management-Global Patient Safety, Darmstadt, Germany.
  • Dieter Kempf
    Genentech, A Member of the Roche Group, South San Francisco, CA, USA.
  • Promit Roy
    Novartis, Chief Medical Office and Patient Safety, Novartis Global Drug Development, Dublin, Ireland.
  • Oeystein Kjoersvik
    R&D IT, MSD, Prague, Czech Republic.
  • Griselda Saldana
    Amgen, Pharmacovigilance Operations, Los Angeles, CA, USA.
  • Sarah ElShal
    Department of Electrical Engineering (ESAT), STADIUS Center for Dynamical Systems, Signal Processing and Data Analytics, KU Leuven and imec, Kapeldreef Leuven, Belgium.