药品监管科学概论课程设计与教学实践探索

Exploration of syllabus design and teaching practice of the course Introduction to Regulatory Science

国家药品监督管理局于2019年启动了中国药品监管科学行动计划,同时推进药品监管科学学科建设和人才培养。为适应医药产业发展和监管科学人才培养需要,研究论证并开设了药品监管科学概论选修课。为探索课程建设总体目标和建设方案,立足中医药院校教育特点,参考中国药品监管科学的学科进展和国家政策,通过调研学生需求和专家论证方式,设计了18学时6个专题的课程教学内容,并在2022年下半年进行了初步实践。问卷调查显示,学生对于新课程与教学给予肯定评价,认为该课程对引领学生客观认识药品监管科学这门新学科,培养本科生跨学科视野和综合创新能力具有重要实践价值,但后续仍需进一步探索新教学模式和教学方法。药品监管科学概论的课程建设和初步实践,将为医药院校推进药品监管科学课程建设和制定人才培养方案提供借鉴和启迪。

Since 2019 when National Medical Products Administration of China launched the national action plan for regulatory science,corresponding discipline and talent training have started.In order to meet the needs of the development of the pharmaceutical industry and talent training,an elective course Introduction to Regulatory Science was proposed,discussed and approved to offer at Beijing University of Chinese Medicine.To set the overall goal and make the plan for starting the course,I took into consideration the educational characteristics of traditional Chinese medicine colleges and universities and the disciplinary progress and national policies of regulatory science.On this basis,I designed the course content around 6 topics to be covered in 18 contact hours by investigating the needs of students and the suggestions of experts.The course was initially offered in fall 2022.My teaching practice and a questionnaire survey showed that the students gave positive feedback to the new course and my teaching,and confirmed that the course has important practical value in guiding students to objectively understand the new discipline of regulatory science,and cultivating interdisciplinary vision and comprehensive innovative ability of undergraduates.However,new ways of teaching should be further explored.The course design and practice of Introduction to Regulatory Science can provide reference and inspiration for medical colleges and universities to promote the establishment of relevant courses and talent training programs.