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Congress report: Online workshop on assessment of technical files for blood screening in vitro diagnostics for
Herbert A Mbunkah1,2, Chancelar Kafere1, Washington Samukange1
1Division G3 - International Coordination, Regulatory Service, Paul-Ehrlich-Institut, Langen, Germany.
Objectives:
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.
Background:
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.
Materialsand Methods:
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.
Results:
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.
Conclusions:
This workshop presented a great starting point for most participating NRAs to set up and/or strengthen their regulatory structures for IVDs.
