目的 强化大数据智能化在智慧城市中的科技支撑,加强药品安全风险管理能力,促进药品监管模式转变升级。方法 借鉴最新的智慧监管理念和药品智慧监管实践,在充分利用、整合现有药品质量数据基础上,提出构建药品质量大数据库的策略、内容和数据库设计。结果 根据制定的药品质量信息建库要求和管理指南,建立起包含药品质量检验信息和不良反应信息的药品质量大数据库、数据分析平台。结论 建立全新药品质量大数据库,深入挖掘和利用数据信息,为开发数据分析平台的多种监管应用,积极探索药品智慧监管的手段和方式,打下良好基础。
Abstract
OBJECTIVE To strengthen the scientific and technological support of big data intelligence in smart cities, strengthen the capabilities of drug safety risk management, and promote the transformation and upgrading of drug supervision mode. METHODS Drawing on the latest intelligent supervision and management practice of drug, on the basis of making full use of and integrating the existing drug quality data, this paper puts forward the strategies 、contents and design of constructing a large drug quality database. RESULTS According to the requirements and management guidelines for the establishment of drug quality information, a large database and data analysis platform containing drug quality inspection information and adverse reaction information were established. CONCLUSION Establishing a brand-new large database of drug quality, digging and utilizing data information in depth will lay a good foundation for developing a variety of regulatory applications of data analysis platform and actively exploring the means and methods of intelligent drug supervision.
关键词
智慧监管 /
药品质量 /
大数据 /
数据库
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Key words
smart supervision /
drug quality /
big data /
database
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中图分类号：
R954
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参考文献
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脚注
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基金
重庆市技术创新与应用示范专项资助(cstc2018jscx-mszdX0119)
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