Talk Risk-Based Quality Management track
From Signals to Decisions: Making RBQM Actionable at the Study-Level
Wed, Oct 14, 2026 · 9:10–9:35 AM CEST InterContinental Barcelona
About this session
Risk-Based Quality Management generates increasing volumes of study-level signals, yet translating those signals into timely, consistent decisions remains a challenge. In the context of ICH E6(R3), this session examines why decisions stall and how to operationalise decision-making in practice. Practical approaches to defining thresholds, clarifying ownership, and enabling timely, traceable actions will support more effective, inspection-ready study oversight and continuous improvement.
Speaker
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TA Director, Oncology, Risk-Based Quality Management · AbbVie
Speaker
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