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RBQM (Risk-Based Quality Management): What Topics Should be Discussed with Whom in the Room?
Session Chair(s)
Terry Katz, MS
Senior Director, Biostatistics and DM Planning and Functional Excellence
Daiichi Sankyo, United States
Critical-to-Quality (CtQ) factors are key to determining which protocol-related processes and variables matter. These should be defined cross-functionally during risk assessment and built into all functional plans to have a common focus and approach.
Learning Objective : Define Critical-to-Quality (CtQ) variables; Streamline CtQ to all functional plans for common approach; Understand the benefits from reduced SDR/SDV by focusing on CtQ as variables that matter.
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