药物安全与药物警戒
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小结(Summary)

在ICSR的整个上报和评估过程中,只有根据国际指导原则、指南和本国、本地区的法律、法规及具体情况对上报过程中的每个环节进行有效管理、质量控制,才能及时准确地提供数据和证据以支持医疗产品的安全性资料,确保高质量的药物警戒和风险管理,由此切实保障科学的决策和人民健康。

During the whole process of reporting and evaluation of ICSR,only effective management and quality control on every single step,based on international guidance,guidelines and the regulations of the local country or region,can assure the provision of data and evidence in a timely and accurate way leading to good pharmacovigilance and risk management,thus ensuring scientific decisions and protecting public health.

(夏 峰)