Project: PhArmaco Vigilance Africa

Acronym	PAVIA (Reference Number: CSA2016S-1627)
Duration	01/03/2018 - 28/02/2022
Project Topic	Aim & Objectives: PAVIA aims to improve the readiness of sub-Saharan Africa (SSA) health systems to effectively deliver new medical products and to monitor their post-market safety. PAVIA’ objectives are: I) To strengthen governance of Pharmacovigilance (PV) systems, by strengthening regulatory and organisational structures and defining clear roles and responsibilities for all stakeholdersII) To improve efficiency and effectiveness of national surveillance systems, by strengthening active (sentinel) surveillance of adverse drug reactions and implementation of tools and technologies for their detection, reporting, analysis and dissemination III) To build capacity and skills to sufficiently conduct safety-monitoring activities throughout the country IV) To improve readiness of health systems within SSA, by improving performance assessment of PV systems allowing identification of enablers and barriers for implementation How these objectives will be achieved: PAVIA’s strategy is to strengthen national PV systems through a highly collaborative effort involving Public Health Programmes (PHPs), Country National Medical Regulatory Authorities (NMRAs) and Medical Research Institutions (MRIs). PAVIA will initially build up medicines safety surveillance activities in the context of the of new drugs and treatment regimens for multidrug-resistant tuberculosis (MDR-TB) introduced through the national tuberculosis programs (NTPs). The national PV Centre/ NMRA within Nigeria, Tanzania, Ethiopia and Swaziland will collaborate with the NTP as well as a local MRI in a “triangular” cooperation in which the MRI provides clinical expertise. This “triangle” will provide a channel for reporting and interpreting safety signals in MDR-TB treatment, serve as a training ground for country PV staff and clinicians, and provide a demonstration project for similar linkages with other disease control programs.Capacity at the PV Centre/NMRA will be built gradually taking the PV activities for tuberculosis as the “building and training ground” for a generic PV system including data collection, database entry, data analysis, signal identification and causality assessment. The results and lessons learned will be transferred by PAVIA to other PHPs, such as those for HIV and malaria. Combined with identified enablers and barriers in addressing regional differences and needs, a blueprint will be developed to that can guide other countries in strengthening their PV systems.The activities in PAVIA are organised along 5 work packages in which 14 partners adopt a collaborative approach in reaching its objectives. PAVIA's alignment with relevant global and regional initiatives is ensured through their representation within the PAVIA International Advisory Board. PAVIA will strengthen the PV surveillance system and capacity of the PV staff within the four participating countries building upon the USAID financed Challenge TB program. Through a collaborative approach between PV, PHP and clinicians, the coverage, accessibility and effectiveness of existing evidence-based interventions will be strengthened not only for MDR-TB but also for other poverty-related diseases.Website and social media links:www.pavia-project.netwww.twitter.com/paviaprojectwww.facebook.com/paviaprojectwww.linkedin.com/company/paviaproject
Network	EDCTP2
Call	Strategic actions supporting health systems/services optimisation research capacities in cooperation with development assistance initiatives

Project partner

Number	Name	Role	Country
1	Stichting Amsterdam Institute for Global Health and Development	Coordinator	Netherlands
2	Armauer Hansen Research Institute	Partner	Ethiopia
3	Ethiopian Food, Medicine and Health Care dministration and Control Authority	Partner	Ethiopia
4	Institute of Human Virology Nigeria	Partner	Niger
5	Koninklijke Nederlandse Centrale Vereniging tot Bestrijding ter Tuberculose	Partner	Netherlands
6	Ministry of Health - Swaziland	Partner	Eswatini
7	National Agency for Food and Drug Administration and Control	Partner	Niger
8	Stichting Lareb	Partner	Netherlands
9	Tanzania Food and Drugs Authority	Partner	Tanzania
10	The Baylor College of Medicine Children’s Foundation	Partner	Eswatini
11	The Good Samaritan Foundation, Kilimanjaro Christian Medical Centre	Partner	Tanzania
12	Università degli Studi di Verona	Partner	Italy
13	University of Benin	Partner	Niger