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美国药品监管科学人才培养实践探究及对我国的启示
引用本文:贺亮,董晨东,茅宁莹,李军.美国药品监管科学人才培养实践探究及对我国的启示[J].中国新药杂志,2021(5):385-393.
作者姓名:贺亮  董晨东  茅宁莹  李军
作者单位:中国药科大学国际医药商学院;华润三九医药股份有限公司
基金项目:中国药科大学“双一流”学科创新团队建设项目(CPU2018GY39);中国药品监督管理研究会资助课题:监管科学发展视角下的药品监管人才能力素质模型研究——基于长三角区域的调查研究(2018);监管科学视角下创新药审评决策自由裁量权研究(2019)。
摘    要:药品监管科学研究与建设已成为世界各国21世纪药品监管战略重点,而人才队伍建设是进行监管科学研究与建设首要考虑的问题之一。我国对于监管科学人才培养尚处于起步阶段,存在人才培养规模小、程度浅、体系乱等突出问题。美国在药品监管科学人才培养方面探索多年,已形成较为成熟的监管科学人才培养体系。本文通过对美国药品监管科学人才培养创新实践进行研究,对其人才培养定位以及具体培养措施进行分析总结,以了解我国在药品监管科学人才培养方面存在的不足,并在此基础上提出完善我国药品监管科学人才培养体系的建议。

关 键 词:监管科学  人才培养  能力素质

The cultivation practice of drug regulatory science talents in the United States under the background of regulatory science and its enlightenment to China
HE Liang,DONG Chen-dong,MAO Nng-ying,LI Jun.The cultivation practice of drug regulatory science talents in the United States under the background of regulatory science and its enlightenment to China[J].Chinese Journal of New Drugs,2021(5):385-393.
Authors:HE Liang  DONG Chen-dong  MAO Nng-ying  LI Jun
Institution:(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing 211198,China;China Resources Sanjiu Medical&Pharmaceutical Co.,Ltd.,Shenzhen 518110,China)
Abstract:The research and construction of drug regulatory science has become the focus of drug supervision strategies in the world in this century,and the construction of talent teams is one of the first considerations in the research and construction of regulatory science. China is still in its infancy in the cultivation of regulatory science talents,and there are prominent problems such as the small scale,shallow degree,and chaotic system of talent cultivation. The United States has been exploring the cultivation of talents for drug regulatory science for many years,and has formed a mature regulatory science talent training system. This article studies the innovative practice of the training of regulatory science talents in the United States,analyzes and summarizes its talent training orientation and specific training measures to understand the deficiencies in China,and on the basis of which,suggestions were put forward to improve the cultivation system of drug regulatory science talents in China.
Keywords:regulatory science  talent training  competency
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