| 宗欣,王迎利.美国FDA哨点行动及其对我国食品药品监管数据管理的启示[J].中国药事,2017,(4):354-357 |
| 美国FDA哨点行动及其对我国食品药品监管数据管理的启示 |
| Sentinel Initiative of U.S. Food and Drug Administration and the Inspiration to Data Management of Food and Drug Administration in China |
| 投稿时间：2016-01-01 |
| DOI：10.16153/j.1002-7777.2017.04.002 |
| 中文关键词: 哨点行动 迷你哨点 数据管理 食品药品监管 |
| 英文关键词: sentinel initiative mini sentinel data management food and drug administration |
| 基金项目: |
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| 摘要点击次数: 958 |
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| 中文摘要: |
| 目的：介绍美国FDA哨点行动背景、项目、内容、特点，为我国食品药品监管数据共享利用和管理提供参考。方法：使用文献研究的方法，围绕美国食品药品管理局哨点行动计划收集材料并梳理分析。结果与结论：信息化和大数据时代背景下数据资源共享与食品药品监管业务工作密不可分；顶层支持有助于数据协同共享等工作开展；分布式数据管理模式值得借鉴；产学研结合有助于开展数据分析挖掘；相关方广泛参与有助于从源头保障数据质量。 |
| 英文摘要: |
| Objective: To put forward suggestions for data management of food and drug administration in China. Methods: The policies, regulations and guidelines of U.S. FDA sentinel initiative released in recent years were collected and analyzed by using the literature research method. Results and Conclusion: In informatization and big data era, data sharing is closely related to food and drug supervision. Support from decision makers can facilitate data sharing and other jobs. The distributed data management mode is worth learning. The combination of production, teaching and research helps to carry out data mining analysis. The extensive participation of interested parties helps to ensure the data quality form the source. |
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