An effective and strong regulatory system for health technologies is critical, especially during epidemics and pandemic situations. The demand for rapid approval and application of a variety of health technologies including diagnostics and medicines during COVID-19 has reawakened the world to the urgent need to have resilient regulatory capacities that can respond in a timely manner with corresponding efficiency. National Medicines Regulatory Authorities and Research Ethics Committees are duty bound to prepare and be ready to respond in any health emergency. Through EDCTP-2-funded projects namely SMERT, PROFORMA, PAVIA and ASCEND, substantial progress has been made on strengthening some procedures for clinical trial control and pharmacovigilance. These projects have enabled Tanzania to attain WHO Maturity level 3, making it a role model in East Africa. Despite of this, health technologies regulation in Tanzania has struggled to cope with emergencies as witnessed in the COVID-19 pandemics due to limited capacity in the area of Research Ethics, therapeutics, vaccines, medical devices and other health technologies. We now propose BREEDIME to further build our capacity in the context of epidemic and pandemic preparedness. BREEDIME will enable Tanzania to achieve rapid response clinical trial regulatory capacity for therapeutics, vaccines, and diagnostics; capacity for post-market evaluation and appraisal of health technologies; establish research ethics framework for electronic health data and materials storage, access and sharing within and outside the country; and establish a south-south learning centre in clinical trials regulatory and ethical review capacities. These objectives will be achieved through engagement of stakeholders in academia, civil society, public and government to generate evidence to inform new regulatory guidelines. This will strengthen health technologies regulation and will enable rapid access to health care and technology during emergency. Rwanda, which recently established her Food and Drugs Agency will become the first mentee under the BREEDIME south-south networking in ethics and medicines regulatory capacity building. The impact of the outputs of this study will be ensuring safety of pre- and post- registration health technologies in Tanzania and East Africa at large.

The project ultimately aims at improving patient care and wellbeing in Tanzania. Central notions in this are: Respectful and Compassiante patient centered Care (RCC), communication skills and Health Literacy (HL).RCC and HL have entered strategic plans in education, but are not truly embedded in educational and professional practice in Tanzania yet. Universities have insufficient tools to develop and implement this within the study programmes. This is also identified by the Ministry of Health (involved in this proposal itself). The project aims at enabling Tanzanian universities (and hospitals) to do so.In concrete terms, the project consists of:- Curriculum development in the fields of RCC, HL, student communication skills, adapted to the situation in Tanzania.- Capacity building at university and hospital level: a train the trainer programme will be developed for Tanzania to start to build a pool of lecturers and clinical instructors, competent in teaching and assessing a curriculum based training for Nursing students in Respectful and Compassionate patient centered Care using Health Literacy communication skills. On the Tanzanian side, the partnership consists of three Tanzanian universities in Health, three referral hospitals and the Ministry of Health, Community Development, Gender, Elderly and Children. On the European side, three universities (schools in Nursing/Health) from Ireland, Norway and the Netherlands are involved, as well as a University Medical Centre in the Netherlands.The project will take place in three regions of Tanzania. It is foreseen that the curriculum and training will be introduced in the other regions as well (after the project period), with the Ministry as leading institution (Tanzania has a national curriculum in Nursing).

The African Great Lakes region is one of the most densely populated areas in Africa and also one of the areas globally with the highest biodiversity, and forced or voluntary migrations. Very limited information is available on the prevalence and epidemiology of infectious diseases, especially gastrointestinal diseases and antimicrobial resistance that has been very understudied. Logistically it is difficult to sample and conventionally study infectious diseases in the area and such studies have limited real-time value locally. In this study we will take full advantage of the potential offered by combining field-deployable nanopore sequencing combined with metagenomics and lap-top bioinformatics, to establish frontline sequencing at remote sites and linking this with central sharing of analytic output. Newly developed bioinformatics solutions by us have made it possible to perform simple bioinformatics analyses in real-time using lap-tops and subsequently share the analytic output simply using the mobile net, avoiding the need of transferring large amounts of data and access to high-performance computing. In GREAT-LIFE we will establish sequencing across six countries in the region and use this to study the abundances of AMR in villages and refugee camps. Linking this with spatial and temporal epidemiological data will enable us to identify locally relevant drivers for AMR and provide data for changing empiric treatment and policies. In addition, we will utilize sequencing directly on GI samples to identify the causative agents (and their AMR) both to provide data for policies, but also to provide immediate results for direct patient care in the frontline. We will educate a number of people in the very frontline to utilize field-sequencing and bioinformatics, as well as more advanced bioinformaticians and epidemiologist centrally. The data generated will be linked in real-time through a central hub in Tanzania to public health authorities for actions.

Diabetes Mellitus (DM) contributes to an estimated 11.3% of adult deaths worldwide. Approximately 1 in 10 adults globally are estimated to have DM and the prevalence will rise significantly over the coming decades, especially in sub-Saharan Africa. People with DM have a three-fold increased risk of developing TB, and two-fold higher risk of dying from TB or experiencing treatment failure or recurrent disease, further threatening global TB control. As such, the growing burden of DM alongside the continuing TB epidemic have huge health and socio- economic impact. PROTID performs the first randomized controlled trial (RCT) globally to evaluate efficacy, safety, cost-utility and population impact of preventive treatment of TB preventive therapy for people with DM. It also examines gaps in diagnosis and management of DM and DM-TB in Uganda and Tanzania. Our results will guide global policy on TB prevention and management in people with DM, and this can have large socio-economic impact. In Africa, this is highly relevant given the double burden of DM and TB. In Europe, our results will be highly relevant for migrants and people living in eastern Europe, as both groups have a high burden of DM, latent tuberculosis infection (LTBI) and TB disease. PROTID’s results so far, and other advancements in the field, have already set clear research priorities beyond PROTID. PROTID is very well-positioned to take these forward, with strengthened leadership and research capacity in PROTID’s African partners embedded in a global research network, and its accumulated data on the largest and most-well characterized longitudinal cohort on DM and TB globally.