中国药物警戒 ›› 2018, Vol. 15 ›› Issue (1): 32-35.

• 法规与管理研究 • 上一篇    下一篇

医药类高校开设药物警戒课程的实践

万帮喜, 肖亮, 徐菊萍   

  1. 嘉兴太美医疗科技有限公司,上海 200013;
  • 收稿日期:2018-02-12 修回日期:2018-02-12 出版日期:2018-01-20 发布日期:2018-02-12
  • 作者简介:万帮喜,男,硕士,中国药物警戒信息化研究。

Practice of Pharmacovigilance Courses Provision at Medical and Pharmaceutical College

WAN Bang-xi, XIAO Liang, XU Ju-ping   

  1. Jiaxing Taimei Medical Technology Co. Ltd, Shanghai 200013, China;
  • Received:2018-02-12 Revised:2018-02-12 Online:2018-01-20 Published:2018-02-12

摘要: 目的 随着制药行业对药物警戒重视程度的不断提高,药物警戒工作的开展得以快速推进,而同时专业人才缺乏,这一影响行业快速发展的问题,正逐渐显现。本文总结了在医药类高校开设药物警戒课程的方法与实践,尝试为制药行业提供药物警戒专业人才。方法 依据制药行业药物警戒工作的专业需求及国际上的实践,在某医药类高校开设药物警戒课程,设计课程内容、授课方式、学时、考核方式,进行药物警戒的教学实践,并在此基础上对开设课程的效果进行评估。结果 从考核结果来看,对药物警戒的基本概念、法规要点等均已正确掌握。有部分学生进入到企业从事药物警戒相关工作,从认知到行为体现出了对药物警戒的理解,说明本课程的讲授在一定程度上达到了专业人才培养的目的。结论 随着高校在开设药物警戒课程实践的不断深入和经验积累,高校教育有望成为解决专业人才缺乏问题的一条有效途径。

关键词: 药物警戒, 大学教育, 课程, 实践

Abstract: Objective With the increasing attention on pharmacovigilance, the pharmacovigilance activities are conducted and developed rapidly. Therefore the problem of pharmacovigilance professionals shortage is gradually emerging. This article summarizes the method and practice of teaching pharmacovigilance in medical college. It attempts to provide pharmacovigilance professionals for the pharmaceutical industry. Methods According to the professional needs of pharmacovigilance in pharmaceutical industry and international education practice, pharmacovigilance courses were set up in a medical college. The curriculum contents and learning hours were arranged and implemented with well prepared teaching Methods. The students also participated in real world working practice activities of pharmacovigilance in a supplier of corresponding services. At the end of courses, the students took an examination for assessment of the learning effects. Results According to the assessment Results, the basic concepts and key points of pharmacovigilance regulations were properly mastered by the students. Some of the students were employed in enterprises and engaged in pharmacovigilance related jobs. The emplyees reflected the understanding of pharmacovigilance from thier cognitions to thier behaviors. The teaching of the courses achieved the purpose of training pharmacovigilance professionals to a certain extent. Conclusion with the deepening of practice and accumulation of experience in pharmacovigilance courses in colleges, college education is expected to become an effective way to solve the problem of professionals shortage.

Key words: pharmacovigilance, college education, course, practice

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