药品上市许可持有人药物警戒远程检查流程探索研究-国际临床研究杂志-CSCIED科技核心评价数据库-手机版

药品上市许可持有人药物警戒远程检查流程探索研究

Study on remote pharmacovigilance examination process for drug marketing authorization holders

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DOI	10.12208/j.ijcr.20240192
刊名	国际临床研究杂志 International Journal of Clinical Research
年，卷(期)	2024, 8(5)
作者	田慧娜*,刘美香,蔡慧玲,郭岩,尹利丹,
作者单位	山东丹红制药有限公司山东菏泽 ; 山东康爱制药有限公司山东菏泽
摘要	随着信息技术的迅猛发展，远程检查作为一种新型的监管手段，在药品上市许可持有人的药物警戒体系中扮演着日益重要的角色。本文围绕持有人展开，深入探讨了药品上市许可持有人药物警戒远程检查流程。文章首先介绍了远程检查的概念、应用背景及其必要性；接着详细阐述了远程检查流程的具体环节，包括准备阶段、实施阶段以及后续处理阶段；随后，通过具体案例分析，揭示了远程检查在持有人实际应用中的优势与面临的挑战；最后，针对存在的问题提出了相应的改进建议。本文旨在为持有人实施药物警戒远程检查提供参考，促进药品监管工作的现代化、信息化和高效化。
Abstract	With the rapid development of information technology, remote inspection, as a new regulatory means, plays an increasingly important role in the pharmacovigilance system of drug marketing authorization holders. This paper focuses on the holder and deeply discusses the remote inspection process of pharmacovigilance for the holder of drug marketing authorization. This paper first introduces the concept, application background and necessity of remote inspection. Then it elaborates the specific links of the remote inspection process, including the preparation stage, the implementation stage and the follow-up treatment stage. Then, through the concrete case analysis, the advantages and challenges of remote inspection in the practical application of holders are revealed. Finally, the corresponding improvement suggestions are put forward in view of the existing problems. The purpose of this paper is to provide reference for the implementation of pharmacovigilance remote inspection, and to promote the modernization, information and high efficiency of drug supervision.
关键词	药品上市许可持有人；药物警戒；远程检查；持有人；监管流程
KeyWord	Drug marketing authorization holder; Pharmacovigilance; Remote inspection; The holder; Supervision process
基金项目
页码	99-102

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引用本文

田慧娜*,刘美香,蔡慧玲,郭岩,尹利丹. 药品上市许可持有人药物警戒远程检查流程探索研究 [J]. 国际临床研究杂志. 2024; 8; (5). 99 - 102.

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