Such a grasp includes realistic assessments of the people, technologies, processes, and methods of the existing environment and proposed solution, and the drawbacks of any potential solution.
这种把握能力包括对于人员、技术、过程、现有环境的方法、已提议解决方案以及任何潜在解决方案缺陷的现实估价。
Risk assessments according to ICH Q9 "are usually the basis for the control strategy and those submitted in the application can justify the proposed flexible regulatory approaches."
根据ICH Q9进行的风险管理“一般是控制策略的基础,在申报资料中提交可以论证所拟的灵活的法规方法”。
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