欧盟临床检查员职业化制度的经验与启示  

Experience and inspiration of European Union clinical inspector professionalization system

作　　者：吴方[1] 于倩 王康冉 王方敏 罗嵇宁 WU Fang;YU Qian;WANG Kang-ran;WANG Fang-min;LUO Ji-ning(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》2020年第7期405-410,共6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);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：欧盟的临床检查员职业化制度较为系统规范,欧盟对于临床检查员的教育培训、工作职责及检查流程已经形成了一套较完备的制度体系,可为我国提供成熟的借鉴。本文结合欧盟对临床检查员的管理,提出强化临床检查员的培训与教育、明确临床检查员的工作职责、完善临床检查工作总结制度和建立检查项目分级管理机制等建议,为推进中国临床检查员职业化制度建设提供依据。The professional system of clinical inspectors in the European Union(EU) is relatively systematic and standardized. The EU has formed a relatively complete system for the training and education, job responsibilities, and specific work processes of clinical inspectors, which can provide a mature reference for China. Based on the EU’s management of clinical inspectors, suggestions were put forward such as strengthening the training and education of clinical inspectors, clarifying the work responsibilities of clinical inspectors, improving the clinical inspection work summary system, and establishing a hierarchical management mechanism for inspection projects, in order to promote the professionalization of Chinese clinical inspectors.

关 键 词：欧盟 临床试验 检查员 职业化 启示 

分 类 号：R951[医药卫生—药学]