日本临床检查员职业化制度的经验与启示  

Experience and inspiration of Japanese clinical inspector professionalization system

作　　者：吴方[1] 徐杨燕 任旭 王方敏 高敏洁 WU Fang;XU Yang-yan;REN Xu;WANG Fang-min;GAO Min-jie(School of International Pharmaceutical Business of China Pharmaceutical University,Nanjing JIANGSU 211198,China;Shanghai Center for Drug Evaluation and Inspection,SHANGHAI 201203,China)

机构地区：[1]中国药科大学国际医药商学院,江苏南京211198 [2]上海药品审评核查中心,上海201203

出　　处：《中国新药与临床杂志》2019年第12期721-725,共5页Chinese Journal of New Drugs and Clinical Remedies

基　　金：教育部人文社会科学研究青年基金项目（19YJC630183）;江苏省高校哲学社会科学研究一般项目（2019SJA0058）;沈阳药科大学亦弘商学院“我国临床检查员胜任力素质研究”课题;中国药科大学国际医药商学院力凡胶囊科研基金（CPUSIPB-LFJJ-04)

摘　　要：日本的临床检查员职业化制度发展较为完善,日本临床检查员的招募、培训、检查流程已形成了一套成熟的制度,对我国有一定的借鉴意义。本文结合日本对临床检查员的管理,提出完善培训教育体系、加强国际化队伍建设、加强国家的引导作用、完善申办方检查制度、完善职业发展通道等经验启示,为推进中国临床检查员职业化制度建设提供依据。The development of the professional system of clinical inspectors in Japan is relatively complete.The recruitment,training and inspection processes of Japanese clinical inspectors have formed a mature system,which has certain reference significance for China.This article combines Japan’s management of clinical inspectors,proposes a training and education system,strengthens the international team,strengthens the country’s guiding role,improves the bidder’s inspection system,and improves the career development channel,in order to promote the professionalization of Chinese clinical inspectors.

关 键 词：日本 临床试验 检查员 职业化 启示 

分 类 号：R951[医药卫生—药学]