药物临床试验质量管理规范培训融入医院药学研究生培养体系的实践与思考  

Integration of good clinical practice training into the master′s degree training system in hospital pharmacy:practical exploration and reflection

作　　者：张基[1] 梁淑红[1] Zhang Ji;Liang Shuhong(Department of Pharmacy,First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan 450052,China)

机构地区：[1]郑州大学第一附属医院药学部,河南郑州450052

出　　处：《中国药物与临床》2025年第3期160-163,共4页Chinese Remedies & Clinics

摘　　要：随着《“健康中国2030”规划纲要》的深入实施,医药创新和药物临床试验的重要性日益凸显。然而,我国药物临床试验设计、风险和质量管理等能力尚待提高,这对临床试验人才培养提出了新的挑战。本文旨在探讨将《药物临床试验质量管理规范》培训融入医院药学研究生培养体系的必要性和实践路径。通过分析当前临床试验发展和人才培养的问题,本文提出了丰富课程内容、创新教学方式、强化实践环节等策略,以期提高药学研究生的临床研究能力。With the in-depth implementation of the"Healthy China 2030 Planning Outline",the importance of pharmaceutical innovation and drug clinical trials has become increasingly prominent.However,the capabilities of drug clinical trial design,risk management,and quality control in China still need to be improved,posing new challenges to the training system for clinical trial related talents.The purpose of this paper is to explore the necessity and practical path of incorporating good clinical practice(GCP)training into the training system for master′s degrees in hospital pharmaceutical sciences.By analyzing the current issues in clinical trial development and talent cultivation,this paper proposes strategies such as innovative teaching methods,enriched course content,and strengthened practical sessions,with the aim of improving the clinical research capabilities of master′s degree candidates in graduate hospital pharmacy.

关 键 词：药物临床试验 药物临床试验质量管理规范 医院药学 研究生教育 培养体系 

分 类 号：R-4[医药卫生] G643[文化科学—高等教育学]