PAVIA

PhArmaco Vigilance Africa

Objective

  1. To strengthen governance of Pharmacovigilance (PV) systems, by strengthening regulatory and organizational structures and defining clear roles and responsibilities for all stakeholders.
  2. 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.
  3. To build capacity and skills to sufficiently conduct safety-monitoring activities throughout the country.
  4. To improve readiness of health systems within SSA, by improving performance assessment of PV systems allowing identification of enablers and barriers for implementation.

Description

PAVIA seeks to support African health systems to effectively and safely monitor, evaluate and deliver new medications locally.

The project focuses on developing local systems and improving the safety of new drugs aimed at treating multi drug-resistant tuberculosis (MDR-TB). The goal is to develop an effective system at country level for management and reporting of adverse reactions to this family of drugs. The results and lessons learned while focusing on the treatments for MDR-TB will be transferred by PAVIA to other public health programs such as the ones on HIV and malaria.

PAVIA is designed on a highly collaborative and synergetic partnership involving four partners from Europe and nine partners drawn from four sub – Saharan African Countries (Ethiopia, Nigeria, Swaziland and Tanzania). In each of these countries, representatives from three key organizations will work together to lead the project. They include:

• The National Medicine Regulatory Authority
• The National TB Public Health program, which is responsible for introducing new TB-related products and medications; and
• A Medical Research Institute connected to a local university

The activities in PAVIA are organised along 5 work packages in which our 13 partners adopt a collaborative approach in reaching our objectives. Alignment with relevant global and regional initiatives such as AMA (African Medicines Agency ) or NEPAD (New Partnership for Africa’s Developmen)t is ensured through their representation on the PAVIA Advisory Board. At the end of the project, PAVIA will deliver a blueprint for strengthening the medication regulatory processes which can be implemented across other Sub-Sahara African countries, ultimately making medications safer for patients across the continent.


AIGHD Research Lead

Prof. dr. Frank Cobelens


Partners

AIGHD
Stichting Lareb
KNCV Tuberculosis Foundation
Università degli Studi di Verona
The Good Samaritan Foundation – Kilimanjaro Christian Medical Centre
Tanzania Food and Drugs Authority
Armauer Hansen Research Institute
Food, Medicine and Health Care Administration and Control Authority of Ethiopia Institute of Human Virology Nigeria
University of Benin
National Agency for Food and Drug Administration Control
Baylor College of Medicine Children’s Foundation Swaziland
Ministry of Health – Swaziland


Funders

European Developing Countries Clinical Trials Partnership (EDCTP)
In-kind co-funding from USAID


Countries

Africa: Ethiopia, Tanzania, Nigeria and Kingdom of Eswatini

Europe: Netherlands, Italy