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Work­shops in Four African Part­ner Coun­tries on Li­cens­ing Blood Es­tab­lish­ments

Through the BloodTrain project, the Paul-Ehrlich-Institut (PEI) has committed to improving the availability, quality and safety of blood and blood products and supports the participating partner countries in developing the necessary regulatory structures. The project is part of the Global Health Protection Programme (GHPP), a programme launched by the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) with the aim of improving health on an international level. The BloodTrain team conducted practical workshops in four African partner countries from March to June 2022 on the subject of quality requirements for blood products and licensing of blood establishments. These workshops also functioned as the kick-off to country-specific development of lacking or insufficient regulatory requirements in the area of blood and blood products regulation.

Slideshow

Why Regulatory Approval Is Important for Safe Blood Products

In order to ensure the quality and safety of blood and blood products, it is necessary that blood establishments adhere to certain standards and that these standards are checked by the authorities. These standards include specifications for the selection and testing of donors, testing methods, collection procedures, production, storage and transport of blood and blood products. Together with its partner countries, the BloodTrain project has set a goal of supporting the development of important regulatory structures for each country in order to increase the safety and effectiveness of blood products.

Virtual E-Learning Offer as a Basis for On-Site Workshops

In order to follow protective measures against the Coronavirus, the BloodTrain team organised its training program on the topic of "Approval and Licensing of Blood Establishments" in two stages: The first workshop, held virtually in July 2021, included lectures with highly practical relevance and best-practice examples of critical steps in the production and storage of blood products. The training content with literature, presentations and audio recordings is still available online for the partner countries via an e-learning platform.

"With more than 170 participants from 17 countries, the virtual knowledge transfer benefited far more interested parties than we could have achieved with on-site training. In addition, the online training has already been able to impart a basic understanding of the topic, the content of which can be accessed at any time via the e-learning platform. With this preparatory work, we were able to use the country visits effectively to go directly into the details and work on missing documents," said Dr Jens Reinhardt, Deputy Head of the BloodTrain Project at the Paul-Ehrlich-Institut.

On-Site Workshops in Zambia, Zimbabwe, Tanzania and Ghana

The second part of the workshop took place on-site and, for the first time, with each partner country individually. As a result, ten employees from the regulatory authority and the national blood donation service were able to participate in each workshop per partner country. The focus was on practical exercises tailored to the regulatory environment of each country. "The country workshops enabled us to go deeper into the country-specific system and document analysis from the outset and to organise the group work accordingly," said Dr Reinhardt. The task was to check which requirements from the WHO Global Benchmarking Tool already apply in each country and which ones are only partially implemented or not at all existent. The agenda also included the analysis of how responsibilities and roles are distributed in the respective country, the sequence of approval processes and the submission of the necessary documents and data. The goal of each workshop was a work plan for the participants with the aim of revising or creating new regulatory documents.

Country-Specific Core Teams Develop Regulatory Requirements

As a next step, the BloodTrain team formed core teams in each country with representatives from the regulatory authority and blood donation service. The teams had the task of developing missing regulatory documents for the approval and licensing of blood donation institutions. "Working with core teams, the task teams that draft the documents, has proven to be very effective in the area of haemovigilance," added Dr Reinhardt.

Updated: 30.06.2022