University of Groningen, Groningen Research Institute of Pharmacy, Pharmacotherapy, Epidemiology and Economics, Groningen, The Netherlands.
Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Drug Saf. 2024 Dec;47(12):1193-1202. doi: 10.1007/s40264-024-01469-7. Epub 2024 Aug 20.
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.
参与药物安全监测和监测的利益相关者的持续专业发展对于加强药物警戒（PV）系统至关重要。“东非药品监管协调的药物警戒基础设施和上市后监测系统能力建设”（PROFORMA）项目旨在加强埃塞俄比亚、坦桑尼亚、肯尼亚和卢旺达的国家 PV 基础设施、上市后监测系统和临床试验监管能力。为此，需要开展包括短期培训（STT）在内的各级培训。本文旨在描述作者在开发和实施 STT 方面的经验，以期改善这些国家的 PV 培训格局。为了确定差距，对国家药品监管机构（NMRAs）和医科大学的 PV 教学和实践进行了基线评估。根据每个国家的具体需求和监管环境，进行了五次连续的培训课程；其中三次侧重于 PV 的基本概念，两次专门针对培训师培训课程。培训针对的是 NMRAs 和医科大学 PV 部门的工作人员。使所有四个国家都能够参加同一培训，促进了跨国学习和合作。探讨了 STT 对大学教育的贡献以及 NMRAs 内的业务方法，展示了在每个国家的知识转移和技能发展方面的影响。总之，通过在 STT 活动上进行战略投资，并与学术机构和 NMRAs 建立伙伴关系，我们展示了在资源有限的环境中加强 PV 能力建设的可持续方法。这种模式的成功突显了其在非洲大陆推广和复制的潜力，为加强药物安全监管并最终保护公众健康提供了宝贵的框架。
