European Drug Safety & AI 2026

24–25 Feb 2026 | Barcelona, Spain

Wednesday, 25 February 2026 | 13:50 - 14:30

INSIGHT EXCHANGE: PV RISK MANAGEMENT IN THE AGE OF AI

Location:Gloria B, C, D
  • THE INDUSTRY IS LARGELY AUTOMATING TASKS, NOT TRANSFORMING RISK-BASED DECISION-MAKING. 

    At what point can an AI-generated insight be considered reliable enough to inform a Risk Management Plan or regulatory strategy decision? 

  • EVALUATING RISK MINIMIZATION MEASURES WITH AI 

    Assessing whether risk minimisation measures are actually working is one of the most valuable things AI could do in PV. Why is it still the weakest link, and what are the practical, regulatory, and organizational barriers to getting there? 

  • IF "CONTINUOUS RMP" POWERED BY AI IS MOSTLY STILL A ROADMAP, WHAT ARE THE REALISTIC FIRST STEPS PV DIRECTORS CAN TAKE TODAY? 

    Most organizations operate in siloed safety systems without a continuous RMP framework. What could a realistic 12–24 month transformation look like, and what governance, data, and change management prerequisites must come first?” 

  • AI CAN TECHNICALLY EXTRACT SIGNALS FROM REAL-WORLD DATA, SO WHY ISN'T IT INFLUENCING OUR RMP DECISIONS YET? 

    The technology exists. The data exists. Yet for most organizations, RWD still doesn't meaningfully feed into continuous risk assessment or RMP updates. Is the barrier the data quality, regulatory, organizational? As PV Directors, which of those barriers do we actually own, and where do we start?

1 speaker

  • Global Safety Director, EU/ EEA QPPV

    Indivior

Location image

Session location Gloria B, C, D