Centre of Excellence for Pharmacovigilance in Southern Africa

Overall objective (Impact):
To strengthen national and regional capacities for effective Pharmacovigilance (PV) to support/foster an enabling environment for local Pharma Research & Development and the regional value chain in South Africa and the Southern African region.
Specific objectives (Outcomes):
• Enhanced skills in PV in South Africa and the Southern African region.
• Increased evidence-based support to National Regulatory Authorities and relevant stakeholders on PV in Southern Africa.
• Increased connectivity and collaboration between relevant stakeholders in Southern Africa, contributing to a stronger value chain.
Target group(s):
• PV healthcare professionals working in PV centres in Southern Africa, who aspire to enhance their skills, and/or to broaden their complementary research and communication skills, and/or extend their professional and scientific network.
• The PV centres where these healthcare professionals work. These include the PV centres in South Africa - SAHPRA, the University of Cape Town (UCT) Medicines Information Centre and the Pharmacovigilance Centre for Public Health Programmes at the National Department of Health, Pretoria-, as well as PV centres of neighbouring Southern African countries (such as Namibia Therapeutics Information and Pharmacovigilance Center (TIPC)). A situational assessment of PV centres and their staff in the Southern African region will be undertaken at the beginning of the project.
• In the longer term, recently graduated healthcare professionals, aiming to move into a career in PV.
Final beneficiaries
• The communities will benefit from better prescribing, dispensing and use of medicines.
• Medical practitioners, pharmacists, nursing personnel and community-level healthcare workers will benefit from improved safety research, preventive safety activities and better
communication on medicines risks.

• Local and international manufacturers that conduct R&D and/or manufacture in the region, because of the added value of mature PV programmes, as well as of well-trained PV experts who may see their position in the labour market change; this would then improve the quality of the pharmaceutical companies’ PV departments, which, in turn, will increase the safety monitoring and the public trust toward locally- manufactured products.
• Regional and national policymakers and health authorities will benefit from locally generated, well-informed policy guidance on safety issues -which will also underpin the health
sovereignty-related policies and practices. Expected outputs
• A Centre of Excellence on pharmacovigilance is established as a hub for training on PV in South Africa and the region
• Awareness and visibility of the PV Centre of Excellence are bolstered
• The Centre of Excellence provides research support on PV in South Africa and the region.
• Capacities of PV experts on science-driven policy support have significantly increased.
• The intervention results and the specific PV advances obtained with the support of the CoE are disseminated within the science-policy context
• The Centre of Excellence on pharmacovigilance supports life-long learning FOR PV experts A multi-year strategy to sustain the role and contribution of the CoE is developed in close collaboration with the relevant national and regional stakeholders. Main activities
1.1.1. Development and roll-out of a unique training programme for PV professionals within NRA and Academic institutions that bridges existing practical training gaps by compiling best practices regionally, and by filling existing knowledge gaps to strengthen National PV programmes.
1.1.2. A mobility programme to allow selected PV officers (from the short course) to acquire practical experience in PV at a recognized regional or international center.
1.1.3. A mentorship programme for selected PV officers (from the short course) to attain international excellence.
1.1.4. Dedicated coaching and pilots on crisis-communication and support to communities related to PV.
1.2.1. Development, roll-out and use of Communication instruments.
2.1.1. Methodological and dissemination support to PV research in the region.
2.2.1. Dedicated coaching to provide policy support is embedded in the programming and activities of the Centre of Excellence.
2.2.2. Dedicated coaching and pilots on crisis communication and support to communities related to PV.
2.3.1. Publishing of results through peer-reviewed publications, presentations at conferences, reports, policy briefs.
2.3.2. Risk-communication support: follow-up webinars, Q&A on safety incidents or controversies if any, infographics.
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2021.1 Annex A1. Grant application form-Concept note _07June rr.docx
3.1.1. Launch and coordination of community of practice (network of excellence) between existing PV experts in South Africa, enriched with alumni of the CoE training cycles.
3.2.1. A (base-line) study and workshop mapping the offer, demand , interests, constraints of PV stakeholders in Southern Africa feeds into a continuous dialogue between stakeholders through annual workshops and the final conference.
3.2.2. Strategy development on multistakeholder involvement, with specific attention to pharmacovigilance and preparedness in view of the local research, development and production initiatives contributes to the projects final conference (see activity 3.2.1)