摘要
本研究旨在为建设和完善我国药品检查员培训体系提供参考。采用文献研究法,从培训实施机构、培训分级制度、培训内容与方式、培训效果评估等方面对比分析美国、欧盟和日本药品检查员培训体系的建设情况及关注要点,并对我国药品检查员培训工作提出建议。研究结果显示,美国、欧盟和日本已建立成熟且完备的药品检查员培训体系,包括专门的培训管理机构、专职化的人员队伍、清晰的职业发展路径、多元化的培训方式及模块化的课程体系等多个方面。而我国药品检查员培训体系尚存在缺乏统一的培训标准、培训没有针对检查员分级分类开展、检查员职业发展通道受阻等问题。建议我国加快建立药品检查员培训指导性规范,并且吸引政产学研多方投入药品检查员培训,另外还可以探索建设药品检查员微专业以重构培训课程体系,同时设置药品检查员专属职称序列,形成专业晋升机制。
The purpose of this research is to provide reference for the construction and improvement of drug inspector training system in China.Literature research method was used to compare and analyze the construction and key points of drug inspector training systems in the United States,the European Union,and Japan from the aspects of training implementation institutions,training grading systems,training content and methods,and training effectiveness evaluation.Some suggestions were put forward for the training of drug inspectors in China.The research results showed that the United States,the European Union,and Japan have established mature and comprehensive drug inspector training systems,including specialized training management institutions,specialized personnel teams,clear career development paths,diversified training methods,and modular curriculum systems.However,there are still problems in the training system for drug inspectors in our country,such as the lack of unified training standards and training targeting the classification of inspectors,and obstacles in the career development path of inspectors.It is suggested that we should accelerate the establishment of guiding standards for drug inspector training,and attract investment from government,industry,academia,and research parties in drug inspector training.In addition,it is also possible to explore the construction of Micro-specialty for drug inspectors to reconstruct the training curriculum system.At the same time,a specialized title sequence for drug inspectors should be established to form a professional promotion mechanism.
作者
孙金瑶
吴方
郭鲁波
张永泽
SUN Jin-yao;WU Fang;GUO Lu-bo;ZHANG Yong-ze(China Pharmaceutical University,Nanjing 210000,China;Jinan Central Hospital,Jinan 250000,China)
出处
《中国新药杂志》
北大核心
2025年第2期130-137,共8页
Chinese Journal of New Drugs
基金
江苏省2022年度药品监管科学研究计划项目:数字赋能视角下江苏省药品临床检查员职业化专业化队伍建设研究
甘肃省2022年度药品科研项目:甘肃省药品检查员岗位胜任力研究与培训体系构建(2022GSMPA0047)。
关键词
药品检查员
培训体系
美国
欧盟
日本
启示
drug inspector
training system
the United States
European Union
Japan
enlightenment
