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Session 4: AI and Digitalization in PV: Regulatory Expectations, Real-World Execution, and QPPV Oversight
Session Chair(s)
Maarten Lagendijk, MSc
Deputy EU QPPV, MSD, Netherlands
Sina Schader, DrMed
Head of QPPV Office and EU QPPV, AbbVie, Germany
Session Overview: This session provides a pragmatic overview for QPPVs navigating the integration of artificial intelligence and digital technologies in pharmacovigilance systems. Attendees will gain insight into current regulatory and inspector expectations regarding AI system validation and compliance baselines. The session will discuss how to implement these technologies using realistic, risk-based approaches, and considerations on how a QPPV can maintain oversight. There will be time for Q&A, equipping you with the information to navigate the developing digital world while maintaining QPPV oversight.
Speaker(s)
Health Authority Expectations on AI
Aise Sukran Renda, MBA
Senior Inspector, Chair of PIC/S AI/ML Working Group, Turkish Medicines and Medical Devices Agency (TMMDA), Turkey
AI Best Practices: Big Pharma Examples
Selim Aydin
Global Head AI & Digital Innovation, Novartis, Switzerland
QPPV Oversight and Training on AI
Fabian Heisig
Head Global Drug Safety & QPPV, Chief Medical Officer, Grünenthal GmbH, Germany
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