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