AI in Pharmacovigilance: The Practical Handbook
PDF eBook · DIN A4 · 136 pages · full colour · regulatory status October 2026

How to take an AI use case in pharmacovigilance from the first idea to inspection-ready operation, and keep it there through change control, monitoring and retirement.

• Lifecycle with five phases and four gates, each with the evidence inspectors ask for
• Regulatory position: amended PV implementing rules, AI Act after the Digital Omnibus, draft GMP Annex 22, EMA reflection paper
• Human oversight designed as a control, and how to test it
• 15 adaptable templates, gate checklists, KPIs and four worked examples

By Reinhold Schilling, Head of Global Pharmacovigilance and EU QPPV.
Instant download after payment. Licensed for personal use.