From SPaRCS to CEPSA – introducing the Centre of Excellence for Pharmacovigilance in Southern Africa
The EDCTP2-funded SPaRCS project (Strengthening Pharmacovigilance and Regulatory Capacity across four Southern African countries), was a key contributor to the establishment of the new Centre of Excellence for Pharmacovigilance in Southern Africa (CEPSA) based at the University of the Western Cape (UWC) in Cape Town, South Africa. SPaRCS was a 3,5 year project from 2020-2023 to strengthen pharmacovigilance (PV) systems and clinical trials oversight in four countries – Eswatini, Namibia, South Africa and Zimbabwe. Learnings from the project found that a multifaceted approach is required to strengthen PV and regulatory capacity including addressing training and research capacity gaps and building communication strategies. Collaborative activities were valued and the country partners were keen to build a community of practice.
CEPSA, which is being supported with a newly signed grant from the European Commission (through the EU Delegation in South Africa) was presented on 25 November 2024 at a Public Health Session hosted at UWC in collaboration with the Department of Science, Technology, and Innovation. The Public Health Session was attended by Mr Marc Lemaître, European Union’s Directorate-General for Research and Innovation (RTD), as part of his visit to South Africa. The session at UWC focused on some of the EU-SA collaborations in the area of public health innovations and included UWC, the South African Medical Research Council (SAMRC) and the Global Health EDCTP3 programme.
CEPSA is an initiative between the Institute of Tropical Medicine, Antwerp in Belgium (ITM) in Europe and the School of Public Health and the School of Pharmacy at UWC. UWC and ITM have been collaborating in the emerging but strategic area of pharmaceutical public health since 2013; and the newly established Centre will leverage the strengths of the collaborating partners.
CEPSA, located at the UWC, with co-leadership and joint expertise at ITM, will lead impactful initiatives to strengthen pharmacovigilance activities in South Africa and more broadly in the Southern African Region. It will strengthen all the components of safety monitoring of medicines and vaccines across their life cycle, from research and development to the post-marketing phase, supporting an enabling regulatory environment for local pharmaceutical research and development and manufacturing.
The Centre will focus on three key areas:
- Advanced training and capacity strengthening in order to support a new generation of PV experts in Southern Africa;
- Providing support to operational research in the field of pharmacovigilance, to maximise the generation and sharing of locally relevant knowledge; and
- Enhancing information and communication systems to enable clear and timely information with public health decision-makers about medicines and vaccine safety.
It will build a network among different stakeholders, including academia, regulators and the local pharmaceutical sector, contributing to regional collaboration and strengthened capacities in pharmacovigilance activities.
The Centre will further leverage and complement the activities of the Team Europe Initiative (TEI) in South Africa on “Manufacturing and access to vaccines, medicines and health technologies in Africa (MAV+)”. In addition to hosting the visit by the DG, UWC will also present the Centre during a workshop on “Implementing the AU-EU Innovation Agenda” at the CSIR – International Convention Centre in Pretoria on 3 December 2024.
The UWC team leading the Centre are Dr Hazel Bradley, Prof. Renier Coetzee, Prof. Michelle Viljoen and Prof. Star Khoza. The ITM team brings together Prof. Raffaella Ravinetto and Dr Carine Dochez, alongside pharmacovigilance experts.