PAVIA and PROFORMA are two large, coordinated, African pharmacovigilance consortia that are part of the EDCTP2 programme supported by the European Union’s Horizon 2020 research and innovation programme:
PharmacoVigilance Africa (PAVIA) aims to strengthen pharmacovigilance in four African countries. To achieve this, collaborative support will be harnessed across several institutions in Europe and Africa including in Ethopia (the Armhauer Hansen Research Institute (AHRI), the Ministry of Health, and the Food, Medicine, and Health Care Administration and Control Authority), Nigeria (the Institute of Human Virology Nigeria (IHVN), the University of Benin, and the National Agency for Food and Drug Administration and Control (NAFDAC)), eSwatini (the Management of Sciences for Health, and Ministry of Health), Tanzania (Kilimanjaro Clinical Research Institute, Moshi, and the Tanzania Food and Drugs Authority (TFDA)), The Netherlands (the Amsterdam Institute of Global Health, the Netherlands Pharmacovigilance Centre Lareb, and the KNCV Tuberculosis Foundation,) and Italy (the University of Verona).
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 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.
PROFORMA is a joint venture between experts from academia, regulatory authorities and other pharmacovigilance stakeholders including: Sweden (Karolinska Institutet), Ethiopia (College of Health sciences, Addis Ababa University and The Ethiopian Food, Medicine and Health Care Administration and Authority (EFMHACA)), Kenya (School of Pharmacy, University of Nairobi and the Pharmacy and Poisons Board (PPB)), Tanzania (Muhimbili University of Health and Allied Sciences (SoP-MUHAS), and the Tanzania Food & Drugs Authority (TFDA)), Ruwanda (University of Rwanda, and the Ministry of Health, Rwanda), and two Regional Centre of Regulatory Excellences (RCOREs) in Africa: PPB: RCORE in Pharmacovigilance, TFDA and SoP-MUHAS: RCORE in medicine evaluation and registration and the WHO collaborating centres in Pharmacovigilance Centre-Lareb.
The aim is to generate a cohort of pharmacovigilance trained/aware patients, healthcare providers, and regulatory staff engaged in pharmacovigilance data collection, analysis, interpretation and data sharing. Emphasis will be given to implement pharmacovigilance in clinical trials regulation and post-marketing surveillance in public health programmes involving mass drug administration and immunization programmes.