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

作　　者：黄文慧 田少雷[1] 董江萍[1] 刘培英 

机构地区：[1]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 [2]北京大学药学院,北京100191

出　　处：《中国药事》2017年第11期1276-1280,共5页Chinese Pharmaceutical Affairs

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。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.

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 

分 类 号：R95[医药卫生—药学] R954.2