Short-Term Training, a Useful Approach for Sustainable Pharmacovigilance Knowledge Development in Tanzania, Kenya, Ethiopia and Rwanda

Eugène Puijenbroek (), Abbie Barry (), Christabel Khaemba (), Lazare Ntirenganya (), Tigist Dires Gebreyesus (), Adam Fimbo (), Omary Minzi (), Eyasu Makonnen (), Margaret Oluka (), Anastasia Guantai () and Eleni Aklillu ()
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Eugène Puijenbroek: University of Groningen, Groningen Research Institute of Pharmacy, Pharmacotherapy, Epidemiology and Economics
Abbie Barry: Karolinska Institute
Christabel Khaemba: Pharmacy and Poisons Board
Lazare Ntirenganya: Rwanda Food and Drugs Authority
Tigist Dires Gebreyesus: Ethiopian Food and Drug Authority
Adam Fimbo: Tanzania Medicines and Medical Devices Authority
Omary Minzi: Muhimbili University of Health and Allied Sciences
Eyasu Makonnen: College of Health Sciences, Addis Ababa University
Margaret Oluka: University of Nairobi
Anastasia Guantai: University of Nairobi
Eleni Aklillu: Karolinska Institute

Drug Safety, 2024, vol. 47, issue 12, No 2, 1193-1202

Abstract: Abstract Continuous professional development among stakeholders involved in drug safety monitoring and surveillance is imperative in strengthening pharmacovigilance (PV) systems. The “Pharmacovigilance infrastructure and post-marketing surveillance system capacity building for regional medicine regulatory harmonization in East Africa” (PROFORMA) project aims to enhance the national PV infrastructure, post-marketing surveillance systems and clinical trial regulatory capabilities in Ethiopia, Tanzania, Kenya and Rwanda. To achieve this, training, including short-term training (STT) activities, at various levels is required. This article aims to describe the experiences of the authors during the development and implementation of STT in an attempt to improve the PV training landscape of these countries. To identify gaps, a baseline assessment of PV teaching and practices at the national medicines regulatory authorities (NMRAs) and medical universities was conducted. Five successive training sessions, tailored to each country's specific needs and regulatory environments, were conducted; three focusing on fundamental concepts in PV and two dedicated to training-of-trainers courses. The training targeted staff from PV units of the NMRAs and medical universities. Enabling participation from all four countries in the same training fostered cross-country learning and collaboration. The contribution of STT to university education and the operational methodologies within NMRAs are explored, showcasing the impact on knowledge transfer and skill development in each country. In conclusion, by investing strategically in STT activities and fostering partnerships with academic institutions and NMRAs, we demonstrated a sustainable approach to PV capacity strengthening in resource-limited settings. The success of this model underscores its potential for adoption and replication across the African continent, offering a valuable framework for strengthening drug safety regulation and ultimately protecting public health.

Date: 2024
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DOI: 10.1007/s40264-024-01469-7

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