摘要
临床试验期间药物警戒是药品全生命周期安全监管的重要内容,本研究对申办者安全性评价及药物警戒体系建设意识较薄弱、临床试验机构不良事件监控手段及药品风险交流意识待提升、研究者收集记录及上报不良事件规范性待加强、跨部门智能化信息上报及沟通协作渠道有待优化等问题进行剖析,并基于全面质量管理理论对临床试验期间药物警戒体系与模式建设进行有益的探索,提出相应对策建议。
Pharmacovigilance is an important content of the whole life cycle of drug safety regulation,this study of the sponsor safety evaluation and pharmacovigilance system construction consciousness is weak,clinical trial institution adverse event monitoring means and drug risk communication consciousness to be promoted,researchers collect records and reporting adverse events normative to strengthen,cross-departmental intelligent information reporting and communication channels to optimize,and based on the comprehensive quality management theory of pharmacovigilance system and mode construction during the clinical trial,and put forward the corresponding countermeasures and suggestions.
作者
秦宇珊
郑伟
潘琪
QIN YUshan;ZHENG WEI;AN Qi(Zhejiang Pharmaceutical Vocational University(Pharmaceutical Business School),Ningbo,Zhejiang 315000;Department of Respiratory and Critical Care Medicine,Affiliated People's Hospital of Ningbo University,Ningbo,ZheJiang 315000)
出处
《智慧健康》
2025年第1期161-164,共4页
Smart Healthcare
基金
2023年浙江省药品监督管理与产业发展研究会项目《基于全面质量管理理论的临床试验期间药物警戒体系与模式建设研究》(项目编号:ZYH2023004)。
关键词
临床试验
药物警戒
不良事件
全面质量管理
Clinical trials
Pharmacovigilance
Adverse events
And overall quality management
