Pharmacovigilance Innovation

Pharmacovigilance is being modernised with AI, real-world data and patient-reported outcomes. The session covers real-world signal detection (FDA Sentinel Initiative, EMA EUDRAvigilance, MHRA Yellow Card), social-media surveillance, machine learning for adverse-event detection in EHRs, FDA Sentinel 2.0, and patient-reported outcomes in safety monitoring. Discussion addresses REMS programmes and evaluation, spontaneous reporting vs active surveillance, post-marketing requirements (PMRs) and commitments (PMCs), cell/gene therapy long-term follow-up, pediatric and pregnancy pharmacovigilance, and AI-driven causality assessment.