实时算法交换和处理药品质量数据和信息
Craig Anderson1, Marquerita Algorri2, Michael J Abernathy2
1Department of Global Regulatory Science - International Labeling Group, Pfizer Inc., Kirkland, Quebec H9J 2M5, Canada.
International journal of pharmaceutics
|August 24, 2023
概括
一种新方法使用了健康7级国际标准.
科学领域:
- 生物制药行业 生物制药行业
- 医疗信息学 医疗信息学
- 监管科学是一种监管科学.
背景情况:
- 目前的制药监管工作流需要几个月到几年.
- 卫生7级国际 (HL7) 快速医疗互操作性资源 (FHIR) 标准用于电子健康记录交换.
- 目前正在为FHIR适应监管用例,包括电子产品信息 (ePI),化学,制造和控制 (CMC) 数据以及不良事件报告.
研究的目的:
- 提出实时药品信息交换的现代方法.
- 为了利用FHIR标准,API,数字化和AI用于制药监管数据.
- 检查FHIR用于CMC信息交换的现实世界实施示例.
主要方法:
- 使用HL7 FHIR标准和API进行数据交换.
- 实施数字化和人工智能来处理信息.
- 专注于生物制药行业内的CMC数据交换.
主要成果:
- 预计将提高效率,减少监管信息管理的时间和精力.
- 加快决策过程的加速.
- 可能将数据交换时间表从几个月缩短为几天或几小时.
结论:
- 拟议的基于FHIR的方法可以显著提高制药监管工作流程的效率和速度.
- 预计这种方法将促进创新,提高信息交换的灵活性.
- 生物制药行业可以通过改进的数字化,自动化和互操作性更快地接触到更多的患者.
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