Live Webinar
Regulatory framework and guidelines for AI in Pharmacovigilance
28th April 2026
From 4 PM to 5 PM (Rome)
From 10 AM to 11 AM (New York)
Abstract
Artificial intelligence is rapidly advancing across industries, and healthcare is no exception. From data screening to AI‑enabled medical devices, AI is transforming processes throughout life sciences—including pharmacovigilance and patient safety. This webinar outline the current regulatory landscape regarding the use of AI in Pharmacovigilance, covering key regulatory obligations as well as good practices for the development, deployment and application of AI tools. Next, we will dive deeper into how AI is applied in Pharmacovigilance today, unpacking the machine learning processes behind the outputs and how to ensure proper transparency and human oversight throughout the AI's lifecycle.
You will gain insight into
The current regulatory framework for AI in PV
Principles on AI good practices in PV
Workflow behind AI solutions in PV, specifically signal management
Speakers

Carolina Dimitrov
Speaker
Pharmacovigilance Compliance Expert
PQE Group

Robert Stoop
Speaker
PV Quality and Compliance Senior Consultant
PQE Group
.png?width=200&height=200&name=Daniela%20(2).png)
Daniela Rota
Moderator
Head of PV and RA Operations
PQE Group
