Fernanda Borrazas

Introduction Global health authorities are actively shaping the future of artificial intelligence (AI) in pharmacovigilance, with new guidelines and frameworks emerging across regions. This article explores how regulators in the United States, Canada, Europe, United Kingdom, Brazil, Mexico, and Australia are responding to AI’s growing role in drug safety. From signal detection to case processing, AI is transforming traditional PV workflows. Authorities are now focused on balancing innovation...

A lot has been said about artificial intelligence (AI) and pharmacovigilance (PV), but for seasoned professionals we should have seen this coming a long time ago. The traditional way PV activities have been conducted relied heavily on manual, resource‑intensive processes. Case processing involved receiving and validating adverse event reports, entering them into databases, and ensuring regulatory submissions were complete. Narrative writing required medical reviewers to craft clear,...

Serious adverse event narratives: background and definitions Before defining case narrative, it is important to explain the concept of Individual Case Safety Report (ICSR); this well-known pharmacovigilance report captures information about adverse events and product problems that are reported to public health, patient safety/quality improvement organizations or regulatory agencies. The ICSR message supports reporting from a variety of sources such as consumers, hospitals, contract research...