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。
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.
出处
《中国药事》
CAS
2017年第4期354-357,共4页
Chinese Pharmaceutical Affairs
关键词
哨点行动
迷你哨点
数据管理
食品药品监管
sentinel initiative
mini sentinel
data management
food and drug administration
