文章摘要
黄文慧,田少雷,董江萍,刘培英.PIC/S检查员培训体系及对完善我国药品检查员培训制度的启迪[J].中国药事,2017,(11):1276-1280
PIC/S检查员培训体系及对完善我国药品检查员培训制度的启迪
PIC/S Inspector Training System and Its Enlightenment on the Improvement of Chinese Drug Inspector Training System
投稿时间：2017-05-05  
DOI：10.16153/j.1002-7777.2017.11.009
中文关键词: 药品检查协定和药品检查合作组织  检查员  培训手段  培训内容  培训制度
英文关键词: PIC/S  inspector  training means  training content  training system
基金项目:
作者单位E-mail
黄文慧 国家食品药品监督管理总局食品药品审核查验中心, 北京 100061
北京大学药学院, 北京 100191 		 
田少雷 国家食品药品监督管理总局食品药品审核查验中心, 北京 100061 tianshl@cfdi.org.cn 
董江萍 国家食品药品监督管理总局食品药品审核查验中心, 北京 100061  
刘培英 国家食品药品监督管理总局食品药品审核查验中心, 北京 100061  
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中文摘要:
      目的：探讨PIC/S组织检查员培训体系的经验，以资在我国完善药品检查员培训制度时借鉴。方法：检索、分析PIC/S组织官方网站以及我国检查员培训方面的文献资料，进行比对研究。结果：PIC/S组织的检查员培训体系具有手段多样、培训内容全面、针对性强等特点，这些均是我国现行检查员培训制度的薄弱环节。结论：PIC/S的培训体系对我国检查员培训制度的建立与完善具有重要的参考和借鉴意义。
英文摘要:
      Objective: To discuss the experience of pharmaceutical inspection convention and pharmaceutical inspection co-operation scheme (PIC/S) inspector training system in order to provide references for improving Chinese drug inspector training system. Methods: The PIC/S offcial website and the literature on Chinese drug inspector training were searched and analyzed. Moreover, the PIC/S training system was compared to the current Chinese drug inspector training system. Results: PIC/S inspector training system has the following characteristics, such as various means, comprehensive content and high pertinence, which are the weakness of current Chinese drug inspector training system. Conclusion: The PIC/S training system has very important referential value for the establishment and improvement of Chinese inspector training system.
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