高职教育食品药品监督管理专业(药械监管方向)教材建设现状与策略探析  

The Present Situation and Strategy of Teaching Material Construction in Respect of Drug and Medical Device Supervision for Food and Drug Supervision Specialty in Higher Vocational Education

作　　者：梁玄 郑海岚 杨田 王海东 吴天河 张梓敏 林秀旎 陈间玲 LIANG Xuan;ZHENG Hai-lan;YANG Tian;WANG Hai-dong;WU Tian-he;ZHANG Zi-min;LIN Xiu-ni;CHEN Jian-ling(Evaluation&Inspection Center of GDMPA;Guangdong Food&Drug Technology Association for Evaluation&Certification;Transaction Center of Guangdong Medical Products Administration;Guangdong Pharmaceutical University)

机构地区：[1]广东省药品监督管理局审评认证中心 [2]广东省食品药品审评认证技术协会 [3]广东省药品监督管理局事务中心 [4]广东药科大学药学院

出　　处：《中国食品药品监管》2025年第3期154-161,共8页China Food & Drug Administration Magazine

摘　　要：加强药品和医疗器械监管是保障人民群众身体健康和生命安全的重要手段。全面加强高职教育食品药品监督管理专业药械监管方向的教材建设对培养医药行业技能人才,有效预防和降低药械质量风险具有重要意义。本文从教材顶层设计、体系整合情况、内容呈现方式、岗位契合度4个维度分析了该专业药械监管方向教材建设现存问题,并从体制机制建设、编写团队组建、“岗课赛证”融通、教材呈现方式创新4个方面提出对策,以期提高人才培养质量,为医药行业发展奠定坚实的基础。Strengthening the supervision of drugs and medical devices is an important means to protect people's health and safety.Enhancing supervision in this field is of great significance not only for training skilled personnel in the pharmaceutical industry but also for effectively preventing and reducing quality risks associated with drug and medical devices.This paper analyzes the existing issues in the construction of teaching materials for drug and medical device supervision from four perspectives:top-level design,system integration,content presentation,and alignment with job requirements.Strategies are proposed focusing on system and mechanism construction,building a competent writing team,integrating“post-course-competition-certificate”programs,and innovating the presentation of teaching materials,aiming to improve talent cultivation and lay a solid foundation for the development of the pharmaceutical industry.

关 键 词：食品药品监督管理 教材建设 高职教育 人才培养 医疗器械 

分 类 号：G714[文化科学—职业技术教育学]