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WHO:2023全球药品监管机构能力框架报告(英文版)(108页).pdf

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1、Global competency framework for regulators of medicinesGlobal competency framework for regulators of medicines Global competency framework for regulators of medicines ISBN 978-92-4-007875-8(electronic version)ISBN 978-92-4-007876-5(print version)World Health Organization 2023Some rights reserved.Thi

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本文主要介绍了全球药品监管者能力框架(Global competency framework for regulators of medicines),由世界卫生组织(WHO)发布。该框架旨在为药品监管机构提供一套全面的能力模型,以加强药品监管体系。 全文分为五个部分: 1. 引言:介绍了框架的背景、目标、范围和预期效益。 2. 监管者能力模型概述:介绍了通用能力模型和药品监管者全球能力模型。 3. 实施:介绍了如何将能力要求应用于组织结构,以及如何制定培训计划。 4. 组织级能力:介绍了元能力、与监管系统核心活动相关的能力和核心能力。 5. 角色特定能力:介绍了审查员、检查员、实验室分析师和警戒人员的角色特定活动和能力。 该框架旨在帮助药品监管机构提高其能力,以更好地履行其职责,确保药品的安全性和有效性。
药品监管者应具备哪些核心能力? 药品监管机构如何实施全球能力框架? 药品监管者如何通过培训提升个人能力?
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