Artificial Intelligence in Pharmacovigilance (AI IN PHARMACOVIGILANCE)

Artificial Intelligence in Pharmacovigilance – Live Online Training Course

Artificial Intelligence in Pharmacovigilance is a comprehensive 3-day Live Online Training Course organized by Fleming Events, taking place from 19–21 October 2026, with daily sessions from 14:00 to 18:00 CEST. This advanced programme is designed for professionals across the pharmaceutical, biotechnology, biologics, and life sciences industries who want to understand how Artificial Intelligence (AI) can be effectively implemented within regulated pharmacovigilance (PV) systems while ensuring compliance, patient safety, and data integrity.

The course will be led by Reinhold Schilling, Head of Global Pharmacovigilance, EU-QPPV and Stufenplanbeauftragter at Wörwag Pharma, Germany, an internationally recognized expert in pharmacovigilance, regulatory compliance, inspection readiness, signal management, vendor oversight, and digital transformation. Participants will also benefit from insights provided by an experienced industry co-trainer.

Throughout the three-day programme, attendees will explore how AI is reshaping pharmacovigilance operations, from case intake, literature screening, duplicate detection, MedDRA coding, narrative generation, quality control, workload prioritization, and signal detection to risk management, benefit-risk evaluation, AI governance, validation, vendor qualification, and regulatory oversight. The training also provides in-depth coverage of **GxP requirements, GAMP 5 principles, EU GMP Annex 11, draft EU GMP Annex 22 considerations, the EU AI Act, EMA/HMA expectations, and relevant ICH guidance**, helping participants understand how to implement AI responsibly while remaining inspection-ready.

The programme combines expert presentations, practical workshops, interactive discussions, group exercises, and real-world case studies to provide hands-on experience in evaluating AI use cases, assessing implementation risks, designing governance frameworks, validating AI-enabled systems, establishing human oversight, and developing scalable AI implementation roadmaps.

What You Will Learn

• Practical AI applications across the pharmacovigilance lifecycle.
• AI-supported case processing, literature screening, MedDRA coding, and signal detection.
• AI governance and regulatory compliance.
• Human oversight and decision-making in AI-assisted PV.
• Validation of AI-enabled systems using GAMP 5 principles.
• Vendor qualification, supplier oversight, and performance monitoring.
• Risk classification, audit trails, data integrity, and inspection readiness.
• Strategies for implementing AI while maintaining patient safety and regulatory compliance.

This programme is ideal for:

• QPPVs and Deputy QPPVs
• Pharmacovigilance Managers and Drug Safety Professionals
• Regulatory Affairs Specialists
• Quality Assurance and Compliance Teams
• Medical Safety and Benefit-Risk Professionals
• Biotechnology and Pharmaceutical Scientists
• AI, Digital Transformation, and PV Technology Leaders
• Computer System Validation (CSV) Specialists
• Vendor Management and Outsourcing Professionals
• Clinical Research and Life Sciences Professionals

Training Features

• Live online expert-led sessions.
• Interactive workshops and practical group exercises.
• Real-world pharmacovigilance case studies.
• Comprehensive digital course materials and implementation checklists.
• Live Q&A sessions with industry experts.
• Networking opportunities with international professionals.
• Practical tools for immediate workplace implementation.
• Official **Certificate of Completion** awarded to all participants who successfully complete the programme.

Event Details

• Event: Artificial Intelligence in Pharmacovigilance
• Format: Live Online Training Course
• Dates: 19–21 October 2026
• Duration: 3 Days
• Daily Time: 14:00–18:00 CEST
• Organizer: Fleming Events
• Lead Trainer: Reinhold Schilling, Head of Global Pharmacovigilance & EU-QPPV, Wörwag Pharma, Germany.

Benefits of Attending

Participants will leave the programme with practical, inspection-ready knowledge that can be immediately applied within their organizations. They will understand how to evaluate AI technologies, strengthen pharmacovigilance processes, improve operational efficiency, reduce compliance risks, enhance data quality, support regulatory inspections, and develop effective AI governance strategies. The course also provides valuable networking opportunities with industry peers and internationally recognized experts, enabling attendees to stay ahead of the latest developments in AI-driven pharmacovigilance.

**Register today to gain practical expertise in Artificial Intelligence for Pharmacovigilance and prepare your organization for the future of AI-enabled drug safety.**

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