监管科学视角下国外药品监管人才能力与素质研究以及对我国人才培养的思考  

Research on the ability and quality of foreign drug regulatory talents from the perspective of regulatory science and thoughts on talent cultivation in our country

作　　者：王芷薇 郑信信 茅宁莹[1] 李军[1] WANG Zhi-wei;ZHENG Xin-xin;MAO Ning-ying;LI Jun(China Pharmaceutical University Institute of Regulatory Science,Key Laboratory for Drug Regulatory Innovation and Evaluation of National Medical Products Administration,Nanjing 211198,China)

机构地区：[1]中国药科大学药品监管科学研究院,国家药品监督管理局药品监管创新与评价重点实验室,南京211198

出　　处：《中国新药杂志》2022年第2期193-200,共8页Chinese Journal of New Drugs

基　　金：产学研深度融合的江苏省生物医药技术创新体系建设研究(BR2020089);江苏省科技厅政策引导类计划(软科学研究)。

摘　　要：近年来,国家大力推进监管科学发展,我国监管科学发展方向和发展路径已初步形成,新监管态势将会对药品监管人员提出新的和更高的要求。本文通过研究监管科学的本质和新时代下监管科学功能和特点,结合国外对药品监管科学人才能力与素质的要求、人才重点培养方向以及具体实践内容,为我国监管科学人才能力的培养和素质的提升提出建议。In recent years,our country has been vigorously promoting the development of regulatory science.The development direction and development path of our country's regulatory science have been preliminarily formed.The new regulatory situation will place new and higher requirements on drug regulation.This article studied the nature of regulatory science and the functions and characteristics of regulatory science in the new era,then combined foreign requirements for the ability and quality of drug regulatory science talents,key training directions,and specific practical content.Then suggestions were put forward for the cultivation and quality improvement of our country's drug regulator talents.

关 键 词：监管科学 能力素质模型 药品监管人员 人才培养实践 

分 类 号：R95[医药卫生—药学]