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The Enhanced Risk-Based Quality Management (RBQM) Approaches for First-in-Human and/or Small Clinical Trials Project within the Risk Based Quality Management Working Group has published a new White Paper.

This paper provides practical recommendations for applying risk‑based quality management (RBQM) in small and early‑phase clinical trials, covering quality‑by‑design principles, risk assessment using critical‑to‑quality factors, targeted monitoring strategies, and approaches to overcome adoption challenges, while ensuring participant safety and regulatory compliance.