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AI/Automation in ICSRs and Signals
Session Chair(s)
James Whitehead, MBA, MSC
Former Senior Director Device & Digital Safety - AstraZeneca, Visiting Lecturer - Pharmacovigilance MSc Course, University of Hertfordshire, United Kingdom
A session exploring how technology can enhance the practice of pharmacovigilance. Starting with an introduction on the landscape, the session’s first speaker will talk us through the EMA article on Artificial Intelligence and how regulators view technology in pharmacovigilance, followed by a member of Industry sharing its views. After both perspectives are offered, a tangible example of technology advancement will be shared.
Learning Objective : • Participants will be introduced to the different trends and technologies in automation intelligence. • Participants will be able to find out the threats associated with the automation intelligence and how to mitigate them • This session will discuss concrete examples of potentials of automation intelligence in the field of drug safety along with the threats that it poses to the industry.
Speaker(s)
Jens-Ulrich Stegmann, MD, RN
Senior Vice President, Head Clinical Safety and Pharmacovigilance and EU QPPV, GSK , Belgium
Trustworthy AI for Safe Medicines
Matthieu Hammer, DRSC, MSC
Head Safety Data Processing and Compliance Management , Merck Healthcare Kgaa, Germany
Optimizing Individual Case Safety Report Management with Process Mining: A Case Study in Pharmacovigilance
Luis Pinheiro, PHARMD, MSC
Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands
Experimentation with AI in Pharmacovigilance: Current EMA Approach
Gabriel Westman, MD, PHD, MSC
Head of Artificial Intelligence, Swedish Medical Products Agency, Sweden
Regulatory Use Cases for AI in Pharmacovigilance
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