European Drug Safety & AI 2026

24–25 Feb 2026 | Barcelona, Spain

Wednesday, 25 February 2026 | 14:30 - 15:00

AI IN PHARMACOVIGILANCE INSPECTIONS: EVIDENCE FROM EVOLVING GVP INSPECTION TRENDS AND PRACTICAL INSPECTION READINESS AND MITIGATION STRATEGIES

Location:Gloria B, C, D
  • Cross‑agency evolution: How EMA, MHRA, and FDA are converging on AI governance, transparency, validation, and human oversight across PV systems. 

  • Evidence from recent inspections: What the 2025 EMA/AGES supervisory inspections and MHRA/FDA initiatives reveal about AI scrutiny in ICSR workflows, chatbots, signals, literature, and IT systems. 

  • Building readiness: Practical strategies to prepare PV systems, affiliates, vendors, and QPPVs for end‑to‑end AI inspection readiness.

1 speaker

  • R&D Quality Regulatory Authority Inspection Management

    Bristol Myers Squibb

Location image

Session location Gloria B, C, D