Since the CIOMS expert Working Group XIV on AI in Pharmacovigilance (PV) kicked off in early 2022, the field has seen some serious momentum. One of the biggest game-changers? The rise of generative AI (GenAI), which has gone from niche tech to mainstream buzzword in what feels like no time. Naturally, this has sparked a lot of excitement about how GenAI could shake things up in PV. But, as with any shiny new tool, there’s a lot to unpack—especially in a highly regulated space like drug safety.
The challenge isn’t just about using GenAI; it’s about using it right. PV is a domain where precision, compliance, and patient safety are non-negotiable, so we can’t just copy-paste AI practices from other industries and call it a day. That’s why the CIOMS group has been laser-focused on creating a roadmap—not a technical “how-to,” but a set of principles and good practices to help navigate this fast-changing landscape. Think of it as a compass for staying relevant and responsible as AI evolves.
This report isn’t about AI in general; it’s about what matters most to PV. It dives into the nitty-gritty of how AI can help with PV-specific challenges, like spotting adverse drug reactions faster or improving case processing. It also tackles some of the thornier issues that might not get as much attention elsewhere—like ensuring transparency in AI-driven decision-making or dealing with the complexities of regulatory compliance.
Bottom line? The world of AI is moving fast, and PV needs to keep up—but with care. This framework is all about making sure we harness the power of AI responsibly, keeping patient safety front and center while staying adaptable to whatever comes next.
The CIOMS Working Group report, Artificial Intelligence in Pharmacovigilance (Draft, 1 May 2025), centers on AI applications that are uniquely relevant to pharmacovigilance or address critical issues within the field. It emphasizes topics of significant importance or priority to PV, even if they are less prominent or applicable in broader AI contexts.
Link: CIOMS-WG-XIV_Draft-report-for-Public-Consultation_1May2025.pdf
