Artificial intelligence in pharmacovigilance. Report of the CIOMS Working Group XIV

Abstract

This report on Artificial intelligence in pharmacovigilance addresses a rapidly emerging cross-disciplinary field that is at the intersection of pharmacovigilance, computer science, mathematics, regulation, law, medicine, human rights, psychology and social science. Consequently, just as with medicinal products, it is important to establish the approved indications, posology, side effects, and warnings and precautions for use of artificial intelligence in pharmacovigilance. The latter must be clearly defined and understood by many people from different backgrounds to propel research and practical implementation in an effective, safe and responsible manner. The diverse pool includes professionals, researchers, and decision makers working in pharmacovigilance in biopharmaceutical industry, regulatory authorities, and academia. It also includes software vendors that develop artificial intelligence solutions for pharmacovigilance, including signal management and all aspects of Individual Case Safety Report processing. This report provides the requisite terminology and conceptual understanding to actively engage in this space, either by participating in the applied scientific research and public discourse, or by performing evaluations and making decisions at their respective organisations.