Division G3 - International Coordination, Regulatory Service, Paul-Ehrlich-Institut, Langen, Germany.
Department of Biological Sciences, Faculty of Science, University of Bamenda, Bambili, Cameroon.
Transfus Med. 2022 Dec;32(6):467-474. doi: 10.1111/tme.12925. Epub 2022 Oct 20.
The online workshop on IVD regulation was performed to broaden the understanding of the technical documentation needed for IVD licensing and the strategies to asses it.
Testing of blood donors and donations significantly reduces the risk of transmitting transfusion-transmissible infections. Many test systems are commercially available, but not all meet the recommended sensitivity and specificity standards. Many African countries either lack functional structures for the regulation of IVDs this poses a threat to the quality of the blood supply.
The Paul-Ehrlich-Institut BloodTrain organised an online workshop in September 2021 to introduce staff from several National Regulatory Authorities (NRAs) in Africa to the regulation of IVD and the technical information that need to be provided by the manufacturers of blood screening IVD. Their evaluation was trained in practical exercises.
This online workshop brought together over hundred participants from NRAs of 12 African countries. Speakers from PEI, Blood Train, WHO and academia, with experience in IVD regulation trained participants in the various topics addressed during this workshop.
This workshop presented a great starting point for most participating NRAs to set up and/or strengthen their regulatory structures for IVDs.
举办在线体外诊断试剂监管研讨会，旨在加深对体外诊断试剂注册所需技术文件的理解，并探讨评估策略。
对献血者和献血进行检测可显著降低经输血传播感染的风险。有许多商业化的检测系统，但并非所有系统都符合推荐的灵敏度和特异性标准。许多非洲国家要么缺乏体外诊断试剂监管的有效机构，这对血液供应的质量构成了威胁。
2021 年 9 月，保罗·埃利希研究所血液培训中心举办了一次在线研讨会，向来自非洲几个国家监管机构的工作人员介绍体外诊断试剂的监管以及制造商需要提供的血液筛查体外诊断试剂的技术信息。他们的评估在实践练习中得到了培训。
此次在线研讨会汇集了来自 12 个非洲国家的 100 多名国家监管机构的参与者。来自 PEI、Blood Train、世卫组织和学术界的演讲者，他们在体外诊断试剂监管方面拥有丰富的经验，培训了参与者关于本次研讨会涉及的各个主题。
本次研讨会为大多数参与的国家监管机构提供了一个很好的起点，以建立和/或加强其对体外诊断试剂的监管结构。
