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

  • check markThe current regulatory framework for AI in PV
  • check markPrinciples on AI good practices in PV
  • check markWorkflow behind AI solutions in PV, specifically signal management

Speakers

Carolina-1

Carolina Dimitrov
Speaker

Pharmacovigilance Compliance Expert
PQE Group

Robert-1

Robert Stoop
Speaker

PV Quality and Compliance Senior Consultant
PQE Group

Daniela (2)

Daniela Rota
Moderator

Head of PV and RA Operations
PQE Group