药物临床研究阶段申办者和生产场地变更研究六: 临床研究阶段申办者和生产场地跨境变更的风险分析
Research Ⅵ on the Changes of Sponsors and Production Sites during the Clinical Research Phase of Drugs:Risk Analysis of Cross-border Changes of Sponsors or Production Sites in the Clinical Research Phase
陈震 1王方敏 2吴正宇 3于冰 4陈江鹏 5高丽萍 5杨建红6
作者信息
- 1. 郑州大学药学院,郑州 450001;沈阳药科大学亦弘商学院,北京 100055
- 2. 上海市药品和医疗器械不良反应监测中心,上海 200040
- 3. 诺和诺德(上海)医药贸易有限公司,上海 200131
- 4. 中国外商投资企业协会药品研制和开发工作委员会,北京 100020
- 5. 沈阳药科大学亦弘商学院,北京 100055
- 6. 国家药品监督管理局药品审评中心,北京 100076
- 折叠
摘要
目的:通过对临床研究阶段申办者、生产场地发生跨境变更时的风险变化进行分析,为申办者和生产场地的跨境变更管理提供参考.方法:基于申办者和生产场地不同组合情形的初始风险评价结果和采取风险管控措施后的风险再评价结果,比较分析不同组合情形之间发生变更时变更前后的"风险指数水平"变化.结果与结论:基于初始风险评价结果,有两种变更情形的风险指数水平在变更后较变更前降低;基于风险再评价结果,有四种变更情形的风险指数水平在变更后较变更前降低.
Abstract
Objective:To evaluate and analyze the risk changes of cross-border changes in sponsors or production sites,and provide reference for the management of cross-border changes in sponsors and production sites.Methods:Based on the initial risk assessment results of different combination modes of the sponsors and production sites,and the risk re-evaluation results after implementing risk control measures,a comparative analysis was conducted on the changes in the"risk index level"before and after the changes occur between different combination modes.Results and Conclusion:Based on the results of the initial risk evaluation,the risk index levels of two change scenarios were lower after the change than before the change,and based on the results of the risk re-evaluation,the risk index levels of four change scenarios were lower after the change than before the change.
关键词
临床研究阶段/申办者/生产场地/跨境变更/风险分析Key words
clinical research phase/sponsor/production site/cross-border change/risk analysis引用本文复制引用
基金项目
中国药品监督管理研究会委托亦弘商学院项目(2021-Y-Y-22)
出版年
2024
NETL
NSTL
万方数据