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血液建立过程中的创新,斯特拉斯堡,2025年:会议报告

Marie Pflieger¹, Annika Sepich¹, Julie Harriague²

¹European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, StrasbourgFrance.

Blood transfusion = Trasfusione del sangue

|November 3, 2025

概括

欧洲药品和医疗保健质量总局会议的重点是血液建立过程中的创新. 讨论的重点是新的人类起源物质 (SoHO) 条例,以提高安全性和供应连续性.

科学领域:

输血医学输血医学
监管科学监管科学
公共卫生公共卫生

背景情况:

欧盟 (EU) 正在从现有指令过渡到新的人类起源物质 (SoHO) 条例 (EU) 2024/1938,自2027年生效.
这一监管转变旨在协调欧盟对来自人类来源的物质的方法.
确保SoHO的高质量和安全标准对于捐赠者和接受者保护以及供应链完整性至关重要.

研究的目的:

总结了国际EDQM血液会议上提出的关键讨论和创新.
探讨即将出台的SoHO法规对血液机构流程的影响.
提高人们对实施新的SoHO法规所带来的好处和挑战的认识.

主要方法:

该报告是基于国际EDQM血液会议的会议记录和讨论,该会议是关于血液机构流程创新的国际EDQM血液会议.
会议记录了会议期间分享的关键主题和专家见解.
重点是确定血液部门的创新实践和监管进步.

主要成果:

会议强调了即将出台的SoHO法规对血液和血液成分质量和安全标准的协调产生重大影响.
参与者分享了各种经验和在献血和血液处理方面的创新策略.
讨论强调了需要做好准备,以解决采用新监管框架的优势和障碍.

结论:

预计SoHO法规的实施将加强健康保护,并确保关键SoHO的稳定供应.
合作和知识共享对于成功导航向新监管格局过渡至关重要.
血液机构流程的持续创新对于满足不断变化的医疗保健需求和监管要求至关重要.

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Blood Transfusion and Agglutination

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Blood transfusion is a therapeutic measure to restore the blood volume after extensive blood loss due to an accident or a medical procedure. Blood transfusion involves drawing a certain amount of blood from a suitable donor and infusing it into the recipient.
History
The history of blood transfusion dates back to the 17th century, when early attempts were made in animals. In 1818 James Blundell, a British doctor, performed the first successful human blood transfusion. Later in 1900, Karl...