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PAVIA Project

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PhArmacoVIgilance Africa (PAVIA) is a consortium which has recently been funded by the European Developing countries Clinical Trialsimages Partnership (EDCTP). The PAVIA project aims to strengthen pharmacovigilance (PV) in four African countries: Ethiopia, Nigeria, Swaziland and Tanzania. To achieve this aim, collaborative support will be harnessed across several institutions in Europe and Africa.

In each of the participating countries, a uniquely designed active triangle will lead the project. This triangle will consist of an intense collaboration of; i) National Medicine Regulatory Authority (including the national pharmacovigilance unit), ii) National Public Health Programme introducing a new product and; iii) local Medical Research Institutes (MRI).

PAVIA will have its initial activities premised on the introduction of new drugs and treatment regimens for multidrug-resistant tuberculosis (MDR-TB) by the National Tuberculosis Programs (NTPs). PAVIA’s focus will include strengthening the processes of routine adverse event reporting in accordance with country policies that already exist (or which will be put in place or strengthened during the course of the PAVIA project). In addition, expert guidance will be provided on causality assessment, signal detection and training at the national and lower levels to support the linkage process between disease control programmes (notably the NTPs) and the National Regulatory Authorities/Pharmacovigilance Agencies.

At the end of the project, PAVIA will deliver a blueprint for strengthening pharmacovigilance that can serve other Sub-Sahara African countries.

*The EDCTP beneficiaries under the PAVIA project are the Amsterdam Institute of Global Health, the Netherlands Pharmacovigilance Centre Lareb and the KNCV Tuberculosis Foundation (The Netherlands), the University of Verona (Italy), Tanzania Food and Drug Authority and Kilimanjaro Clinical Research Institute (Tanzania), University of Benin, Institute of Human Virology and National Agency for Food and Drug Administration Control (Nigeria), Baylor International Pediatric AIDS Initiative and Ministry of Health (Swaziland), Armauer Hansen Research Institute and Food, Medicine and Health Care Administration and Control Authority (Ethiopia)

EDCTP (The European & Developing Countries Clinical Trials Partnership) is a public-public partnership between 14 European and 15 sub-Saharan African countries. The EDCTP2 programme funding PAVIA is supported under Horizon 2020, the European Union’s Framework Programme for Research and Innovation.

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