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WHO世界卫生组织:2026年世界卫生组织模型风险管理计划(RMP)评估工具(英文版)

发布者:wx****b6
2026-03-24
2 MB 71 页
医疗 世界卫生组织
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WHO世界卫生组织:2026年世界卫生组织模型风险管理计划(RMP)评估工具(英文版).pdf
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The WHO Model RMP Assessment Tools comprise a guidance document, a standardized template, and a model SOP to support National Regulatory Authorities (NRAs) in conducting consistent, transparent, and risk-based evaluations of Risk Management Plans (RMPs). They are intended for regulators, pharmacovigilance assessors, and technical experts who review RMPs for medicines and vaccines throughout the product lifecycle. The tools aim to strengthen regulatory decision-making, enhance capacity for saf


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