药品评价抽验的综合管理模式研究

发布时间：2018-03-19 22:31

本文选题：药品　切入点：抽验　出处：《中国新药杂志》2017年01期 　论文类型：期刊论文

【摘要】：药品评价性抽验是上市后监管的重要手段,也是目前大数据战略的热点。然而对于每个承检机构而言,时间紧、任务重已逐步成为常态,因此高效管理已成为必需。作为评价抽验的组织管理部门之一,中国食品药品检定研究院化学药品检定所在回顾性研究的基础上,形成流程化管理模式;通过采取4个基本策略,在高效完成评价抽验工作的同时,在12个方面取得了突破,因此相关思路也在2015年度中国食品药品检定研究院管理创新工作评比中获奖。本文通过对多年的抽验材料进行研究,梳理组织管理脉络,分析实施要点,为提高药品评价抽验管理的工作效率提供参考。
[Abstract]:Drug evaluation sampling is an important means of post-market supervision, and also a hot spot of big data's strategy. However, for every inspection organization, time is tight and the task has gradually become the norm. Therefore, efficient management has become a necessity. As one of the organization and management departments for evaluation and sampling inspection, the Chemical Control Institute of the China Food and Drug Control Institute has formed a process management model on the basis of retrospective research. By adopting four basic strategies, a breakthrough has been made in 12 aspects while the evaluation and sampling work has been completed efficiently. Therefore, the relevant ideas were also awarded in the evaluation of the management innovation work of the China Institute for Food and Drug Control in 2015. Through the study of the sampling materials for many years, this paper combs the context of organization management and analyzes the key points of implementation. It provides a reference for improving the efficiency of drug evaluation and sampling management.
【作者单位】：中国食品药品检定研究院;
【分类号】：R95

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