戻る Agenda
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)
Trustworthy AI for Safe Medicines
Jens-Ulrich Stegmann, MD, RN
GSK , Belgium
Senior Vice President, Head Clinical Safety and Pharmacovigilance and EU QPPV
Optimizing Individual Case Safety Report Management with Process Mining: A Case Study in Pharmacovigilance
Matthieu Hammer, DRSC, MSC
Merck Healthcare Kgaa, Germany
Head Safety Data Processing and Compliance Management
Experimentation with AI in Pharmacovigilance: Current EMA Approach
Luis Pinheiro, PHARMD, MSC
European Medicines Agency, Netherlands
Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce
Regulatory Use Cases for AI in Pharmacovigilance
Gabriel Westman, MD, PHD, MSC
Swedish Medical Products Agency, Sweden
Head of Artificial Intelligence