management cost summary-current 管理成本汇总
Summary of business management 商务管理概述
Project management system summary 项目管理系统总结
Summary Staff Management System 简易员工管理系统
Training records summary and management 员工培训记录的汇总
An important part of the document is the Annex 1 providing the example of a risk management summary (RMS) which lists the 24 elements of the ich Q3D guideline in a table.
文件中一个重要的部分是附录1,它提供了一个风险管理总结(RMS)的样例,其中以表格方式列出了ICH Q3D指南中的24个元素。
Risk Management Summary report should be provided in module 3 of the dossier, in the form of a Table, as described in Annex 1 of this document (preferably in CTD section 3.2.
风险管理摘要报告应在申报文件的第3模块中提交,采用表格方式,按本文件和附录1所述形式(最好是在CTD第3.2。
The ICH Q3D guideline emphasises developing a risk-based control strategy to limit elemental impurities which is summarised in an appropriate "Risk Management Summary" document.
ICH Q3D指南强调了开发基于风险的控制策略来限制元素杂质,该方法在“风险管理总结”文件里进行汇总。
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