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Session 1: Artificial Intelligence in Pharmacovigilance
Session Chair(s)
Doris Irene Stenver, MD, MPA
Independent Pharmacovigilance Adviser, Unique Advice, Denmark
Nicolas Tsiakkas, MD
Scientific Director, Greece
Artificial Intelligence in Pharmacovigilance is an area where the degree of confusion is proportionate to the number of published information and advertisement of AI products that will offer “holistic and integrated SaaS solution that covers everything”. The aim of this presentation will be to demystify AI, explain what automation solutions are and, present the current status of developments in this field, their chances of making it to PV practice and the experience and position of the regulatory authorities. QPPVs will receive adequate input that will help them, among others, decide whether it is time to seriously deal with AI or just keep watching until a viable solution is in sight.
Speaker(s)
Phil Tregunno
Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Regulators’ perspective – Legal framework
Marco Anelli, MD
Principal Consultants Coordinator and Head of Data, Information, Knowledge & , Productlife Group, Italy
Industry Perspective
Salvatore Giorgio Cicirello, PHARMD
Senior Director Safety Science & PASS, Celgene a BMS Company, Switzerland
Industry Perspective
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