短期培训是坦桑尼亚、肯尼亚、埃塞俄比亚和卢旺达可持续发展药物警戒知识的有效方法。

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Eugène van Puijenbroek, Abbie Barry, Christabel Khaemba, Lazare Ntirenganya, Tigist Dires Gebreyesus, Adam Fimbo, Omary Minzi, Eyasu Makonnen, Margaret Oluka, Anastasia Guantai, Eleni Aklillu
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引用次数: 0

摘要

要加强药物警戒(PV)系统,参与药物安全监测和监督的利益相关方必须不断进行专业发展。药物警戒基础设施和上市后监测系统能力建设促进东非地区药品监管协调"(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药物警戒基础设施、上市后监测系统和临床试验监管能力。为此,需要在各个层面开展培训,包括短期培训 (STT) 活动。本文旨在介绍作者在制定和实施 STT 期间的经验,以改善这些国家的 PV 培训状况。为了找出差距,我们对国家药品监管机构 (NMRA) 和医科大学的光伏教学和实践进行了基线评估。根据各国的具体需求和监管环境,连续举办了五次培训课程;其中三次侧重于光伏的基本概念,两次专门用于培训员培训课程。培训对象是来自国家医疗卫生机构光伏部门和医科大学的工作人员。让所有四个国家的人员参加同一培训促进了跨国学习与合作。我们探讨了 STT 对大学教育的贡献以及国家医疗资源管理局内部的操作方法,展示了 STT 对各国知识转让和技能发展的影响。总之,通过对 STT 活动进行战略性投资,并促进与学术机构和国家监测和评估机构的合作,我们展示了在资源有限的环境中加强光伏能力的可持续方法。这一模式的成功强调了其在整个非洲大陆采用和推广的潜力,为加强药品安全监管并最终保护公众健康提供了一个宝贵的框架。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Short-Term Training, a Useful Approach for Sustainable Pharmacovigilance Knowledge Development in Tanzania, Kenya, Ethiopia and Rwanda.

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.

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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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