基于监管科学的医疗器械监管人才培养探索设计  

Design of Training Talents in Medical Device Regulation Based on Regulatory Science

作　　者：刘清峰[1] 刘洋[1] 蒋海洪[1] 金京[1] 魏俊璟 朱文明[1] Liu Qingfeng;Liu Yang;Jiang Haihong;Jin Jing;Wei Junjing;Zhu Wenming(Shanghai University of Medicine ＆ Health Sciences,Shanghai 201318,China)

机构地区：[1]上海健康医学院,上海201318

出　　处：《中国药事》2018年第11期1500-1504,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:阐述在我国设立医疗器械监管本科专业人才培养方案,为监管科学的发展提供参考。方法:在介绍美国监管科学人才培养实践基础上,总结出值得我国人才培养的借鉴要点,结合监管科学的要求,给我国监管人才培养方案的制定以启迪。结果与结论:医疗器械监督与管理本科专业的设立标志着监管科学正式纳入我国普通高等教育序列,将为我国医疗器械监管事业培养一批专业人才,缓解行业对专业人才的需求,有助于为医疗器械监管培养领军人物打下基础,缩小与发达国家之间的差距。但医疗器械监督管理专业的设立毕竟是全国第一次开设,有些问题亟待解决,有些问题尚未弄清楚,有待于在今后的培养过程中予以总结论证和调整规范。Objective： To introduce the training program for undergraduate talents in medical device regulation in China and to provide references for the development of regulatory science in China. Methods： The key points worthy of the talent training in China were summarized based on the introduction of the practice of training talents in regulatory science in U.S. Combined with the requirements of regulatory science, the key points enlightened the formulation of regulatory personnel training program in China. Results and Conclusion： The establishment of medical device regulation and management program for undergraduates indicated the formal integration of the regulatory science into the higher education in our country, which will train a group of professional talents for medical device regulation, alleviate the demand for professional talents in this field, lay the foundation for the training of leading personnel in medical device regulation and narrow the gap with developed countries. However, because it is the first time to establish a medical device regulation and management program in China, some problems need to be solved or clarified, which remain to be summed up and adjusted in future training process.

关 键 词：监管科学 医疗器械 监督管理 人才培养 

分 类 号：R95[医药卫生—药学]