Role of regulatory agencies
Role of regulatory agencies
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DOI：
10.1016/j.biologicals.2009.01.004
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发表时间：
2009-04-01
期刊：
影响因子：
1.7
通讯作者：
Reddy, Ravi
中科院分区：
文献类型：
--
作者：
Epstein, Jay;Seitz, Rainer;Reddy, Ravi
本文论述了监管在保障血液安全中的作用。在一位著名专家对这一主题进行概述之后，提供了几个国家和地区输血服务监管制度的例子。此外，世卫组织的观点是国家监管当局在确保国家血液规划的质量方面的重要作用，总的来说，本文件的各节为读者提供了一个机会，使不同的监管框架之间的比较和现有系统之间的“基准”。尽管在方法上存在许多差异，但在全世界加强血液监管系统的努力中出现了一个明确的模式。由Elsevier Ltd代表国际生物制品协会出版。
In this paper the authors discuss the role of regulation in assuring blood safety. After an overview of the subject by a leading expert, examples are provided of regulatory systems for blood transfusion services in several Countries and regions. Additionally, the perspective of WHO is given on the essential role of national regulatory authorities in assuring the quality of national blood programmes.Collectively, the sections of this paper afford an opportunity for readers to make comparisons among different regulatory frameworks and to "benchmark" among the existing systems. Despite many differences in approach, a clear pattern emerges of worldwide efforts to strengthen blood regulatory systems. Published by Elsevier Ltd on behalf of The International Association for Biologicals.