Many of the issues of healthcare quality and safety are consequences of poor management of pharmaceuticals. Globally it is estimated that an average 25% of the total health expenditure is on medicines, with poorer countries spending as much as 30%. Knowledge of the full supply chain cycle of pharmaceuticals and practical skills to enhance its performance are important, not only for managers in leadership positions but for all health workers. Supply chain management activities are fundamental to any health programme's performance and all personnel involved, whether it's an inventory manager in a warehouse, a doctor in a health facility or a procurement officer at the central medical store, must have a good understanding of the basic principles of managing health commodities.

This course is designed to introduce you to the basic concepts of supply chain management with specific focus on pharmaceuticals and health commodities in a developing country context. Whilst covering a broad range of topics, the course delivery will emphasize the importance of integrating supply chain activities for overall health system strengthening.
Course programme

There is currently a strong momentum for the strengthening of the local pharmaceutical sector in developing and emerging markets. Regional and national strategies to promote local pharmaceutical production in line with international standards are being developed. Besides 'modern' or 'western' medicines, this also includes herbal and traditional medicines - in line with their increasing popularity and market shares worldwide.

While the rationale for local production is simple - including factors such as independence from donor programmes which may not run forever, more steady supply chains, and greater control to local regulators - there is still a long way to go and markets are tough... Local companies, especially in low and middle income countries, often face substantial hurdles.

One of the big challenges is the lack of a qualified human resources base in the manufacturing sector of medicines and other healthcare products. In particular, there is need for skilled personnel for quality units (quality assurance, quality control) and other GMP relevant areas. Costs for bringing in experts from abroad are high. Combined with other challenges, local manufacturers often struggle to compete and even survive. Not being in line with international quality standards, they are prevented from passing WHO prequalification, participating in international tenders, and entering international markets.

Moreover, the national medicines regulatory agencies (NMRAs) of these countries experience a shortage too of qualified staff in GMP, GMP inspection and dossier evaluation. This creates difficulties for the NMRAs to enforce internationally acceptable regulatory requirements (including GMP standards) thereby preventing the availability of affordable quality generics for the majority of their low income population groups.

Traditional and herbal medicines have great potential and can enrich the modern medical landscape – given that they are safe, effective and quality-assured. Despite the requirement to follow GMP standards for production of traditional and herbal medicines, not all actively producing manufacturers, especially in developing countries, comply with international GMP standards - with potential serious consequences for the health of consumers.

This e-learning course introduces Good Manufacturing Practices for medicines and healthcare products, including herbal and traditional medicines. The course focuses on WHO GMP standards and requirements as one of the major GMPs. Course participants will learn about GMP requirements, including procedural, organizational and infrastructural aspects, as well as about the GMP inspection process. They will be able to critically analyse and implement basic GMP requirements in their daily working routine in the manufacturing and regulatory environment. The participants will practice course contents in quizzes, assignments, and discussion forums. While the main focus is on medicines, an extra session of the course introduces the requirements for healthcare products, specifically for female condoms.

In the end, these capacity building measures in the area of GMP and GMP inspection will make participants from local manufacturers and national regulatory authorities better equipped for production and regulation of quality assured essential medicines and healthcare products, in line with national and international standards.

Course programme

Many of the challenges related to healthcare quality and stock-out situations in low and middle income countries are consequences of poor warehouse management of medicines. Appropriate warehousing of medicines, health products and medical laboratory supplies is an essential component of the supply chain management system, required to maintain the integrity of the health products and prevent stock-out or overstocking at any given time.

This course is designed to introduce you to good warehousing practices for medicines and health products within the health system. We will look at warehouse operations in detail covering the receipt, storage and dispatch of essential medicines. Other topics directly related to warehousing are health and safety, waste management and inventory control. Special focus will also be placed on monitoring and evaluation indicators for warehousing, quality assurance, and rational use.

Course programme

O acesso a medicamentos essenciais a preços acessíveis é um dos grandes desafios de hoje em países de baixa e média renda. Ele foi reconhecido como tal nos Objetivos de Desenvolvimento do Milénio (ODM) e agora faz parte dos Objetivos de Desenvolvimento Sustentável. O relatório 2015 da ONU resumindo o progresso dos objetivos calculou a disponibilidade de medicamentos genéricos em países de baixa e média renda em uma média de 58% nos centros de saúde públicos e 67% nas farmácias privadas. Ainda assim, a disponibilidade não é o único desafio. Muitos dos problemas de qualidade e segurança em matéria de saúde pública são devidos a má gestão da cadeia de aprovisionamento. No entanto, os medicamentos são caros. Globalmente, estima-se que 25% do orçamento da saúde é alocado aos medicamentos. Em países com menos recursos, esse valor sobe para 30%. Compreender a cadeia de aprovisionamento de medicamentos do início ao fim, e ter habilidades práticas para melhorar o seu desempenho, são hoje faculdades essenciais para um grande número de profissionais em todos os níveis do sistema de saúde. Eles também são necessários para muitos gestores de programas de saúde que contêm um elemento de abastecimento. Este curso que abrange todas as etapas da cadeia de aprovisionamento de medicamentos e dá uma introdução às funções de gestão mais importantes (como são a garantia de qualidade e o monitoreo e avaliação) esta destinado para fazer isso. Além disso, faz ênfase especial na integração entre as atividades de aprovisionamento e o reforço global do sistema de saúde. O corpo de seu ensino está firmemente apoiado pelos muitos anos de experiência no aprovisionamento de medicamentos essenciais como parceiro de projetos de cooperação internacional pela ONG holandesa i+solutions.

Course programme

Assurer la qualité des médicaments est un problème majeur de santé publique. L'émergence de médicaments de qualité inférieure et contrefaits, liée à des systèmes de chaîne logistique inefficaces, présente non seulement un risque de résultats négatifs en matière de santé, mais peut également mener à des pertes économiques et à un manque de confiance dans le système de santé. Pour faire face à ces problèmes et développer des stratégies fondées sur des données probantes, il est important que les individus à tous les niveaux, des décideurs politiques aux agents de santé principaux, comprennent le besoin de systèmes d'assurance qualité efficaces.

Ce cours vous présentera les concepts et principes essentiels de l'assurance qualité, et vous permettra de développer des compétences et connaissances dans différents aspects de l'assurance qualité comme la réglementation pharmaceutique, la pharmacovigilance et le contrôle qualité des médicaments.

Course programme

Il existe de nombreux enjeux découlant du nombre croissant des acteurs dans le secteur de la santé des pays en voie de développement. Divers acteurs ont souvent différent mécanismes de financement et conditions de rapport, ce qui complique davantage la quantification des médicaments essentiels et des fournitures médicales. Le cours répond aux défis rencontrés lors de la prévisions et la quantification des médicaments essentiels, y compris les médicaments anti-VIH/SIDA, antipaludéens et antituberculeux. Il vise à renforcer les capacités des participants à maîtriser les tâches de prévision et quantification et à décider du processus de planification d’approvisionnement approprié en se basant sur une analyse approfondie des données.

Course programme

Bon nombre des problèmes de qualité et de sécurité des soins de santé sont les conséquences de la mauvaise gestion des produits pharmaceutiques. La connaissance du cycle de la chaîne d'approvisionnement complète de produits pharmaceutiques et les compétences pratiques pour améliorer ses performances sont importantes, non seulement pour les gestionnaires des postes de direction, mais pour tous les travailleurs de la santé. Activités de gestion de la chaîne d'approvisionnement sont essentielles à la performance de tout programme de santé et l'ensemble du personnel impliqués, qu'il s'agisse d'un gestionnaire d'inventaire dans un entrepôt, un médecin dans un établissement de santé ou un agent d'approvisionnement au magasin médical central, doit avoir une bonne compréhension des principes de base de la gestion des produits de santé.

Ce cours est conçu pour vous présenter les concepts de base de la gestion de la chaîne d'approvisionnement en mettant l'accent spécifique sur les produits pharmaceutiques et les produits de santé dans un contexte de pays en développement. Bien que couvrant un large éventail de sujets, la prestation de cours mettra l'accent sur l'importance de l'intégration des activités de la chaîne d'approvisionnement pour l'ensemble renforcement du système de santé.

Course programme

The course “Procurement of Medicines and Medical Supplies” covers every area of the procurement process with a special focus on procuring essential health commodities. To understand how medicines procurement differs from procurement of other goods, one needs to consider the key characteristics of medicines and health commodities in general (such as international non-proprietary name, storage conditions, shelf life, packaging, quality standards, regulatory requirements, psychotropics/narcotics and patents).

Procurement plays a critical role in ensuring the availability of essential quality-assured medicines at all times at an affordable price for the people that need them.

Often international donor organisations and governmental organisations are involved in funding medical programs, resulting in the need of professionally run procurement processes. This course pays special attention to meeting the most common donor requirements and public procurement regulations.

The course guides the student through all steps of the procurement process, such as supplier selection, how to select the best value offer, contracting, quality assurance, measuring supplier performance and much more.

The objective of the course is to provide students solid knowledge about and a good understanding of the procurement process that will help them implement and/or professionalise procurement processes.

The procurement course is suitable for procurement/purchase officers, logistic officers, health officers and professionals with a responsibility in procurement, members of tender committees, pharmacists, program managers and supply chain managers in the public and private sector.

Course programme

Ensuring the quality of medicines is a major public health concern. The emergence of substandard and counterfeit medicines, coupled with inefficient supply chain systems, not only poses a risk of negative health outcomes but also leads to economic losses and lack of trust in the health system. To address these issues and develop evidence-based strategies, it is important that people at all levels, from policy makers to primary healthcare workers appreciate and comprehend the need for effective QA systems.

This course will introduce you to the concepts and main principles of quality assurance, and will develop further skills and knowledge in different aspects of quality assurance such as pharmaceutical regulation, pharmacovigilance and quality control of medicines.

Course programme

Il existe de nombreux enjeux découlant du nombre croissant des acteurs dans le secteur de la santé des pays en voie de développement. Divers acteurs ont souvent différent mécanismes de financement et conditions de rapport, ce qui complique davantage la quantification des médicaments essentiels et des fournitures médicales. Le cours répond aux défis rencontrés lors de la prévisions et la quantification des médicaments essentiels, y compris les médicaments anti-VIH/SIDA, antipaludéens et antituberculeux. Il vise à renforcer les capacités des participants à maîtriser les tâches de prévision et quantification et à décider du processus de planification d’approvisionnement approprié en se basant sur une analyse approfondie des données.

Course programme

There are many challenges ensuing from the increasing number of stakeholders in the health sector of developing countries. Different stakeholders often have different funding mechanisms and reporting requirements, which makes quantification of essential medicines and medical supplies more complicated. The course addresses the challenges faced during the forecasting and quantification of essential medicines, including HIV/AIDS medicines, antimalarials and TB medicines. It aims at building up the participants’ capacity to master the forecasting and quantification tasks and to decide for the appropriate procurement planning process based on a profound analysis of the data.

Course programme

Ensuring the quality of medicines is a major public health concern. The emergence of substandard and counterfeit medicines, coupled with inefficient supply chain systems, not only poses a risk of negative health outcomes but also leads to economic losses and lack of trust in the health system. To address these issues and develop evidence-based strategies, it is important that people at all levels, from policy makers to primary healthcare workers appreciate and comprehend the need for effective QA systems.

This course will introduce you to the concepts and main principles of quality assurance, and will develop further skills and knowledge in different aspects of quality assurance such as pharmaceutical regulation, pharmacovigilance and quality control of medicines.

Course programme

Assurer la qualité des médicaments est un problème majeur de santé publique. L'émergence de médicaments de qualité inférieure et contrefaits, liée à des systèmes de chaîne logistique inefficaces, présente non seulement un risque de résultats négatifs en matière de santé, mais peut également mener à des pertes économiques et à un manque de confiance dans le système de santé. Pour faire face à ces problèmes et développer des stratégies fondées sur des données probantes, il est important que les individus à tous les niveaux, des décideurs politiques aux agents de santé principaux, comprennent le besoin de systèmes d'assurance qualité efficaces.

Ce cours vous présentera les concepts et principes essentiels de l'assurance qualité, et vous permettra de développer des compétences et connaissances dans différents aspects de l'assurance qualité comme la réglementation pharmaceutique, la pharmacovigilance et le contrôle qualité des médicaments.

Course programme

El acceso a medicamentos esenciales a precios asequibles es uno de los grandes retos de hoy en día en los países de bajos y medianos ingresos. Fue reconocido como tal en los Objetivos de Desarrollo del Milenio (ODM) y ahora forma parte de los Objetivos de Desarrollo Sostenible. El informe de la ONU de 2015 que resume los avances en los objetivos calculó la disponibilidad de medicamentos genéricos en países de bajos e medianos ingresos en un promedio de 58% en centros de salud pública y 67% en las farmacias privadas.

Aún así, la disponibilidad no es el único reto. Muchos de los problemas de calidad y seguridad en el ámbito de la salud pública se deben a la mala gestión de la cadena de suministro. No obstante, los medicamentos son costosos. A nivel mundial, se estima que 25% del presupuesto destinado a la salud se asigna a medicinas. En los países con menos recursos, esta cantidad sube hasta un 30%.

Entender la cadena de suministro de medicamentos desde principio a fin, y tener capacidades prácticas para mejorar su rendimiento, son hoy en día facultades esenciales para un gran número de profesionales a todos niveles del sistema de salud. También son necesarios para muchos gestores de programas sanitarios que contienen un elemento de abastecimiento. Este curso que cubre todos los pasos de la cadena de suministro de medicamentos y da una introducción a sus funciones directivas más importantes (como son la garantía de calidad y el monitoreo y evaluación) es destinado a hacer esto. Además, pone especial énfasis en la integración entre las actividades de suministro y el fortalecimiento global del sistema de salud. El cuerpo de su enseñanza está firmemente sustentado por los muchos años de experiencia en abastecer medicamentos esenciales como socio de proyectos de cooperación internacional por la ONG holandesa i+solutions.

Course programme