Background

The GHPP BloodTrain project at PEI seeks to ensure availability, safety and quality of blood products in Africa through regulatory systems strengthening, focusing on haemovigilance, licensing and inspection of blood establishments, and IVDs in five partner countries (Ghana, Nigeria, Tanzania, Zambia, Zimbabwe). The first phase of the project started 2018 and ended in December 2022. Here, we present the achievments from the first phase and give an outlook to the recently started second phase.

Methods

The BloodTrain Project works to strengthen the regulatory capacity in sub-Sahara Africa with the focus on Blood and Blood products. Based on the results of a benchmarking using the Global Benchmarking Tool of the WHO, we have been pursuing a three-tiered approach to

provide specialized technical support to build regulatory structures; perform capacity-building activities like workshops; support continental technical working groups to foster the harmonization of regulatory requirements in Africa.

During the first phase of the project, the activities were maintained during the Covid-19 Pandemic by using a self-developed eLearning platform to perform virtual workshops, and online meetings to advance regulatory documents.

Results

We progressed on all three tiers and achieved important milestones, which will enable our further progress in the currently ongoing second phase of the program:

Our technical support activities lead to the development of numerous regulatory documents, including a unified haemovigilance framework and guidelines in Ghana, launched in October 2022. For capacity building we performed numerous workshops including participants from our five partner countries and as well as from other interested countries. This was especially possible during the online courses (see Table in Abb.1). Concerning the effort to harmonise regulation we supported the development of three Guidance documents by the African Blood Regulators Form.

Conclusion

Together with NRA and NBTS of our partner countries, we supported the strengthening of the regulatory systems, measured by the number of performed workshops and trained participants and the number of developed regulatory system documents.

These results are the basis for the continuing work in the second phase to further strengthen the capacities of our partner countries' NRAs so that they can perform trainings of regulators from neighboring countries in the regulation of Blood Products.

Offenlegung Interessenkonflikt:

Die Autoren haben keinen Interessenkonflikt.