Industry Perspective on Artificial Intelligence/Machine Learning in Pharmacovigilance

Raymond Kassekert, Neal Grabowski (), Denny Lorenz, Claudia Schaffer, Dieter Kempf, Promit Roy, Oeystein Kjoersvik, Griselda Saldana and Sarah ElShal
Additional contact information
Raymond Kassekert: GlaxoSmithKline, Global Safety
Neal Grabowski: AbbVie, Pharmacovigilance and Patient Safety Business Process Office
Denny Lorenz: Bayer AG, Medical Affairs and Pharmacovigilance, Pharmaceuticals
Claudia Schaffer: Merck Healthcare, Case and Vendor Management-Global Patient Safety
Dieter Kempf: Genentech, A Member of the Roche Group
Promit Roy: Novartis Global Drug Development
Oeystein Kjoersvik: MSD, R&D IT
Griselda Saldana: Amgen, Pharmacovigilance Operations
Sarah ElShal: UCB, IT Patient Safety

Drug Safety, 2022, vol. 45, issue 5, No 5, 439-448

Abstract: 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.

Date: 2022
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DOI: 10.1007/s40264-022-01164-5

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