风险管理在药品审评核查机构应用.docVIP

风险管理在药品审评核查机构应用 　　摘 要 目的：探讨如何在药品审评核查机构开展风险管理，以积极地面对风险，确保实现预期的目标，更有效地管理变更，利用资源，实现良好的内部控制并不断改进。方法：参考英国MHRA风险管理框架，结合上海药品审评核查中心开展风险管理的经验，探讨在药品审评核查机构开展风险管理的策略。结果与结论：深入开展政府风险管理已成为当前的国际趋势，在当前深化机构和行政体制改革，以及深化药品审评审批制度改革的大背景下，药品审评核查机构需要根据自身特点，建立风险管理系统，不断完善内部运行的风险控制机制，同时需要注重切实增强全体工作人员的风险管理意识，提高机构在深化改革的大浪潮中应对风险和把握机遇的能力。 　　关键词 风险管理 药品审评核查机构 应用 　　中图分类号：R951 文献标志码：C 文章编号：1006-1533（2018）13-0052-04 　　Application of risk management in drug evaluation and inspection institution 　　SHI Lyuyan*， ZHANG Hua， JIN Dezhuang** 　　（Shanghai Center for Drug Evaluation and Inspection， Shanghai 201203， China） 　　ABSTRACT Objective： To discuss the strategy for risk management in drug evaluation and inspection institutions so as actively confront risks， ensure that the desired goals can be achieved， the changes can be managed and resources can be used more effectively， and finally to achieve good internal controls and make the improvement to be continued. Methods： The strategy for risk management in drug evaluation and inspection institutions was explored by referring to risk management framework and guideline of MHRA and combining with the experience of our center. Results Conclusion： Implementation of risk management in governmental institutions has become an international trend， which corresponds to the domestic environment of deepening reform of institutional and administrative system and the review and approval system of drug. Drug evaluation and inspection institutions should establish internal control system based on their business objective and continuously improve their internal operation risk control mechanism， and meanwhile they should pay attention to effectively strengthen the awareness of risk management of all staff and improve the ability of institutions to cope with risks and seize opportunities in the process of deepening reforms. 　　KEY WORDS risk management； drugs evaluation and inspection institution； application 　　?τ谝┢芳喙苋嗽崩此担?风险管理的概念并不陌生。《药品生产质量管理规范》（2010年修订）中明确要求“应当根据科