PICS检查员培训体系及对完善我国药品检查员培训制度的-中国药事.PDFVIP

1276 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 1,2 1* 1 1 （1. 国家食品药品监督管理总局食品药品审核查验中 黄文慧 ，田少雷 ，董江萍 ，刘培英 心，北京 100061；2. 北京大学药学院，北京 100191） 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。 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 R95 R954.2 A 1002-7777(2017)11-1276-05 中图分类号： ； 文献标识码： 文章编号： doi:10.16153/j.1002-7777.2017.11.009 PIC/S Inspector Training System and Its Enlightenment on the Improvement of Chinese Drug Inspector Training System 1,2 1* 1 1 Huang Wenhui , Tian Shaolei , Dong Jiangping , Liu Peiying (1. Center for Food and Drug Inspection of CFDA, Beijing 100061, China; 2. School of Pharmaceutical Science, Peking University, Beijing 100191, China ) Abstract 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 official 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. Keywords: PIC/S; inspector; training means; training content; training system 药品质量关系着广大人民群众的生命安全， 检查员。为了建设一支专业化的检查员队伍，对 对药品生命全周期进行监管，保障药品质量安