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Report from the GHPP-BloodTrain inspection workshop in Harare the 20th to the 24th of May 2019.
Biologicals ( IF 1.7 ) Pub Date : 2020-09-06 , DOI: 10.1016/j.biologicals.2020.08.012
Washington T Samukange 1 , Verena Klümpers 1 , Chancelar Kafere 1 , Frank Schuler 2 , Florence Jonazi Tirane 3 , Beatrice Kabaso 3 , David Chama 4 , Edwin Ajiga Ejeh 5 , Jens Reinhardt 6
Affiliation  

During the training workshop on Inspection of Blood Establishments, which was hosted by the PEI GHPP BloodTrain in Harare from the 20th to the 24th of May 2019, participants from the National Regulatory Authorities from seven Sub-Sahara African countries presented their current experiences related to regulation and inspection of blood establishments in their respective countries. While in all seven countries regulation and inspection of conventional medicinal products manufacturer is performed, the regulatory situation of blood and blood components as well as inspection of blood establishments is still heterogeneous.



中文翻译:

2019 年 5 月 20 日至 24 日在哈拉雷的 GHPP-BloodTrain 检查车间报告。

在 PEI GHPP BloodTrain 于2019 年 5 月20 日至 24在哈拉雷举办的血液机构检查培训研讨会期间,来自撒哈拉以南非洲七个国家的国家监管机构的参与者介绍了他们目前与监管和检查各自国家的血液机构。虽然在所有七个国家都对常规药品生产商进行了监管和检查,但血液和血液成分的监管情况以及血液机构的检查仍然存在异质性。

更新日期:2020-09-06
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