| 黄宝斌,许明哲.欧洲官方药品质量控制实验室联盟管理机制介绍[J].中国药事,2019,33(4):408-415 |
| 欧洲官方药品质量控制实验室联盟管理机制介绍 |
| Introduction to the Management System of European Official Medicines Control Laboratories Network |
| 投稿时间：2018-10-11 |
| DOI：10.16153/j.1002-7777.2019.04.010 |
| 中文关键词: 欧洲官方药品质量控制实验室联盟 欧洲药品健康管理局 资质管理和申请 |
| 英文关键词: European Official Medicines Control Laboratories Network European Directorate for the Quality of Medicines qualification management and membership application |
| 基金项目: |
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| 摘要点击次数: 1281 |
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| 中文摘要: |
| 目的：介绍欧洲官方药品质量控制实验室联盟的管理机制，为我国药检系统的管理和能力建设提供借鉴。方法：通过调研和查阅欧洲药品健康管理局（EDQM）发布的系列关于欧洲官方药品质量控制实验室联盟的章程、制度和技术指导原则，以及与欧洲药品质量控制实验室同行面对面的交流，全面详细地了解欧洲官方药品质量控制实验室联盟的资质管理、状态评估和成员申请等各项组织管理工作。结果与结论：在秘书处的统一协调领导下，欧洲官方药品质量控制实验室联盟在资质管理、成员申请等方面具有一套严格完整的工作程序和评估办法，确保各成员实验室能够按照联盟的要求高质量地履职尽责。 |
| 英文摘要: |
| Objective: To introduce the management system of European Official Medicines Control Laboratories Network (OMCL) in order to provide references for the management and capacity building of drug control institutes in China. Methods: The items about organization management such as the management of qualification, status assessment and member application of the European OMCL were discussed in great details based on the survey and reviews of the charters, regimes and technical guidelines about European OMCL issued by European Directorate for the Quality of Medicines (EDQM), as well as face-to-face communications with the staff of the European OMCL. Results and Conclusion: Under the unified coordination and leadership of the secretariat, the European OMCL has formed a rigorous and complete set of working procedures and assessment methods for qualification management and membership application to ensure that each member laboratory can completely fufill its responsibility according to the requirements of the European OMCL. |
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