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M. B. Mello
1
M. Bakare
1
M. D. S. de Latini
1
M. F. Silveira
1
M. Fabiola Arias, et al.
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Marchiol, A
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The Global guidance framework for the responsible use of the life sciences: mitigating biorisks and governing dual-use research (the framework) aims to provide values and principles, tools and mechanisms to support Member States and key stakeholders to mitigate and prevent biorisks and govern dual-u...se research.
The framework adopts the One health approach and focuses on the role that responsible life sciences research can play in preventing and mitigating risks caused by accidents, inadvertent or deliberate misuse with the intention to cause harm to humans, nonhuman animals, plants and agriculture, and the environment.
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The WHO BioHub Biosafety & Biosecurity: criteria and operational modalities sets out the requirements to which laboratories wishing to receive biological materials as part of this international exchange system should abide, to ensure safe and secure operations. These provisions are in accordance wit...h the recommendations of the WHO Laboratory Biosafety Manual 4th edition (LBM4), adopting an evidence- and risk-based approach to enable scalable and adaptable biosafety provisions and actions, proportionate to the assessed risk
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The HHFA Comprehensive guide serves as the main reference document for planning and implementing a country HHFA. This guide will promote understanding of:
What the HHFA is and the information it can and cannot provide.
The HHFA modules, questionnaires and CSPro electronic data collection tool.
Th...e HHFA indicators, indices and their organization within the HHFA indicator inventory platform.
The HHFA data analysis platform.
The HHFA sampling and data collection methodologies.
The detailed steps involved in planning and implementing an HHFA.
Key concepts in review, interpretation and communication of HHFA findings.
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The Africa Centres for Disease Control and Prevention (Africa CDC) Biosafety and Biosecurity Initiative was launched by the Africa CDC in April 2019 with the aim of strengthening the African Union (AU) Member States’ biosafety and biosecurity systems and enabling them to comply with national and i...nternational requirements for biosafety and biosecurity including the International Health Regulations (IHR) (2005), the Biological Weapons Convention (BWC), and United Nations Security Council Resolution (UNSCR) 1540 and the multi-country Global Health Security Agenda (GHSA). The World Health Organization (WHO) Joint External Evaluation (JEE) and the Global Health Security Index report confirmed the known capacity gaps in biosafety and biosecurity among Africa Union Member (AU).
The regional consultations by Africa CDC conducted between 2019-2021 highlighted the deficiency or limited availability of standardized and regionally recognized training programs in the continent, limiting biosafety and biosecurity capacity building efforts in the region. In response, Africa CDC working with AU Member States developed a home grown, implementable and accessible professional training and certification program that is both recognized and endorsed by AU Member States. The Regional Training and Certification Program for Biosafety and Biosecurity Professionals, for African Biosafety and Biosecurity Professionals (RTCP-BBP) has four (4) areas of specialization, namely
Selection, Installation, Maintenance and Certification of Biological Safety Cabinets
Biorisk Management
Design and Maintenance of Facilities Handling High Risk Pathogens (Biocontainment Engineering)
Biological Waste management
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The Africa Centres for Disease Control and Prevention (Africa CDC) Biosafety and Biosecurity Initiative was launched by the Africa CDC in April 2019 with the aim of strengthening the African Union (AU) Member States’ biosafety and biosecurity systems and enabling them to comply with national and i...nternational requirements for biosafety and biosecurity including the International Health Regulations (IHR) (2005), the Biological Weapons Convention (BWC), and United Nations Security Council Resolution (UNSCR) 1540 and the multi-country Global Health Security Agenda (GHSA). The World Health Organization (WHO) Joint External Evaluation (JEE) and the Global Health Security Index report confirmed the known capacity gaps in biosafety and biosecurity among Africa Union Member (AU).
The regional consultations by Africa CDC conducted between 2019-2021 highlighted the deficiency or limited availability of standardized and regionally recognized training programs in the continent, limiting biosafety and biosecurity capacity building efforts in the region. In response, Africa CDC working with AU Member States developed a home grown, implementable and accessible professional training and certification program that is both recognized and endorsed by AU Member States. The Regional Training and Certification Program for Biosafety and Biosecurity Professionals, for African Biosafety and Biosecurity Professionals (RTCP-BBP) has four (4) areas of specialization, namely
- Selection, Installation, Maintenance and Certification of Biological Safety Cabinets
- Biorisk Management
- Design and Maintenance of Facilities Handling High Risk Pathogens (Biocontainment Engineering)
- Biological Waste management
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Trustworthy, evidence-based health guidelines form the basis of national policies affecting both patients and health-care workers. Emphasizing the link between robust evidence and people’s trust in their health systems, Dr Hans Henri P. Kluge, WHO Regional Director for Europe said at the launch ev...ent, “Trust and transformation are key words for us, especially when we talk about improving and strengthening our health systems. Transformation should first and foremost serve the interests of patients and health-care workers”.
While it is not always easy to demonstrate the immediate effect of guidelines on people’s health, there is no viable alternative to utilizing guidelines based on the best available evidence.
Yet, developing robust guidelines remains a challenge for most countries. “Guidelines need to be both simple to use and timely, they need to address people’s real needs, especially at the local level, and should ultimately reflect the resources available,” said Dr Natasha Azzopardi-Muscat, Director, Country Health Policies and Systems, WHO/Europe. “This means that any successful guideline needs to be adjusted and adapted to local contexts and realities.”
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Health facilities in the Region of the Americas frequently suffer the effects of health emergencies and disasters, which jeopardize their ability to provide services to the population. The STAR-H methodology helps staff responsible for health emergency and disaster risk management to identify and as...sess risks as part of strategic planning to improve facility preparedness. It is intended to help them develop, with a multi-hazard approach, a response framework with operating procedures to deal with hazards of any type, scale, or frequency; determine roles and responsibilities; facilitate the effective use of resources; undertake strategic planning exercises, and improve the preparedness of facilities to effectively respond to and recover from impacts. This methodology is designed for use in health facilities of any size and capacity, and makes it possible to generate historical reports and national or subnational risk profiles. This information can be used to develop an effective health emergency and disaster risk management program.
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En esta nota técnica se explican los 20 aspectos que deben considerarse para evaluar el estado y la seguridad del equipo y los suministros de laboratorio. No se incluyen en este trabajo las instrucciones para los evaluadores de los puntos 93 (Estado y seguridad del equipo médico en las salas de op...eraciones y salas de recuperación) y 94 (Estado y seguridad del equipo de radiología e imagenología), que también forman parte del índice de seguridad hospitalaria.
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Adolescence is a critical stage in life for physical, cognitive and emotional development, shaping future health and well-being. Comprehensive measurement of adolescent health is essential to prioritize health issues, guide interventions and track progress. However, global, regional and national ado...lescent health measurement has historically been inconsistent and incomplete.
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The Virtual cGMP Training Marathon for Vaccine Manufacturing: Principles into Practice took place from 12 Sep to 10 Oct 2023 to continue to provide manufacturers & regulators with a comprehensive array of topics to build understanding of current WHO & international GMP standards, technological advan...cements, industry practices and regulatory expectations specific to the vaccine manufacturing context. Some of the topics include computer system validation, data integrity, challenges in lyophilization and others. Real world examples and case studies will be used to show how to interpret current and recently new good manufacturing practices requirements from a practical point of view and to implement appropriate approaches.
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Medical devices are used for the prevention, diagnosis and treatment of illness and diseases and for rehabilitation. WHO developed guidance on medical device donation in 2011, which has been now reviewed, with new evidence, new references on considerations for medical device solicitation and provisi...on, risks associated with inappropriate donations, the responsibilities of donors and recipient, and the steps they should follow before, during and after a donation. It includes three sections: description of major problems that may be faced during the donation process, listing of best practices for donors and recipients and addressing situations requiring special attention. It also has three annexes for further reading: the criteria for the acceptability of a donation, literature review on donations of medical devices between 2010 and 2023 and a flyer. This document is intended to improve the quality of medical devices donations, including medical equipment, single-use medical devices and in-vitro diagnostics, to provide maximum benefit to all stakeholders. The considerations can be used to develop institutional or national policies and regulations for medical devices donations. This document is intended for use by any organization, expert or practitioner involved in the donation, procurement, management of medical devices, including health workers, biomedical engineers, health managers, policymakers, donors, nongovernmental organizations and academic institutions.
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Providing quality, stigma-free services is essential to equitable health care for all and achieving global HIV goals and broader Sustainable Development Goals related to health. Every person has the right to the highest attainable standard of physical and mental health. Countries have a legal obliga...tion to develop and implement legislation and policies that guarantee universal access to quality health services and address the root causes of health disparities, including poverty, stigma and discrimination.
The health sector is uniquely placed to lead in addressing inequity, assuring safe personcentred care for everyone and improving social determinants of health by overcoming taboos and discriminatory or stigmatizing behaviours associated with HIV, viral hepatitis and sexually transmitted infections (STIs). Improving health care quality and reducing stigma work together to enhance health outcomes for people living with HIV. Together, they make health care services more accessible, trustworthy and supportive. This encourages early diagnosis, consistent treatment and improved mental well-being. Thus, people living with HIV are more likely to engage with and benefit from health care services, leading to improved overall health.
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This manual describes some of the strategic, managerial, financial, technical and scientific aspects to be considered in establishing a national EQA programme for clinical laboratories and other testing services at all health care levels
The provision of safe and efficacious blood and blood components for transfusion or manufacturing use involves a number of processes, from the selection of blood donors and the collection, processing and testing of blood donations to the testing of patient samples, the issue of compatible blood and ...its administration to the patient. There is a risk of error in each process in this “transfusion chain” and a failure at any of these stages can have serious implications for the recipients of blood and blood products. Thus, while blood transfusion can be life-saving, there are associated risks, particularly the transmission of bloodborne infections.
Screening for transfusion-transmissible infections (TTIs) to exclude blood donations at risk of transmitting infection from donors to recipients is a critical part of the process of ensuring that transfusion is as safe as possible. Effective screening for evidence of the presence of the most common and dangerous TTIs can reduce the risk of transmission to very low levels. more
Screening for transfusion-transmissible infections (TTIs) to exclude blood donations at risk of transmitting infection from donors to recipients is a critical part of the process of ensuring that transfusion is as safe as possible. Effective screening for evidence of the presence of the most common and dangerous TTIs can reduce the risk of transmission to very low levels. more
La fourniture de sang et de produits sanguins sûrs et efficaces pour la transfusion ou la fabrication d’autres produits sanguins fait intervenir un certain nombre de processus, allant de la sélection des donneurs de sang et de la collecte, au traitement et au dépistage des dons de sang ainsi qu...’à l’analyse des échantillons des malades, à la délivrance de sang compatible et à son administration au patient. Il existe un risque d’erreur à chaque étape de la « chaîne de transfusion », et une défaillance à une quelconque de ces étapes peut avoir des conséquences graves pour les receveurs du sang ou des produits sanguins. Si la transfusion sanguine peut sauver des vies, elle comporte aussi des risques, en particulier la transmission des infections par le sang.
Le dépistage des infections transmissibles par transfusion (ITT) en vue d’exclure les dons de sang présentant un risque de transmettre une infection du donneur aux receveurs est une étape critique du processus visant à garantir au mieux la sécurité des transfusions. Un dépistage efficace des agents transmissibles par le sang les plus courants et les plus dangereux peut réduire le risque de transmission à des niveaux très faibles. more
Le dépistage des infections transmissibles par transfusion (ITT) en vue d’exclure les dons de sang présentant un risque de transmettre une infection du donneur aux receveurs est une étape critique du processus visant à garantir au mieux la sécurité des transfusions. Un dépistage efficace des agents transmissibles par le sang les plus courants et les plus dangereux peut réduire le risque de transmission à des niveaux très faibles. more
External quality assessment (EQA) is an important component of quality systems for blood transfusion services. Establishing external quality assessment programmes for screening of donated blood for transfusion-transmissible infections (TTI): implementation guide aims to support WHO member States in ...establishing and operating EQA programmes for screening donated blood for TTI. The guides has been designed for use by national health authorities and EQA organizing institutions in the development of EQA programme. It will also give participating laboratories an insight into the organization of EQA programmes for TTI screening and an understanding of the benefits of participation.
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L’évaluation externe de la qualité (EEQ) est une composante importante des systèmes qualité des services de transfusion sanguine. L’EEQ est l’évaluation externe de la qualité générale des résultats obtenus par un laboratoire dans l’analyse d’échantillons de contrôle dont le cont...enu est connu, mais n’a pas été dévoilé, et la comparaison de ces résultats avec ceux qu’ont obtenus d’autres laboratoires qui ont analysé les mêmes échantillons. Dans les laboratoires qui pratiquent le dépistage des infections transmissibles par transfusion (ITT) dans les dons de sang, la participation à l’EEQ aide à surveiller et améliorer la qualité des résultats. Les informations issues de l’EEQ permettent d’améliorer continuellement la qualité en mettant en évidence les erreurs d’un laboratoire et d’appliquer des mesures pour éviter qu’elles se reproduisent. L’EEQ joue ainsi un rôle essentiel dans l’amélioration de la sécurité transfusionnelle.
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Laboratory Biossafety Manual
Reporting system for the general public - This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. The purpose is to help countries set up a well-organized and effective consumer reporting system within their pharmac...ovigilance centre. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
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Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa
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The survey aimed at evaluating the quality of selected antimalarials in six countries of sub-Saharan Africa (Cameroon, Ethiopia, Ghana, Kenya, Nigeria and the United Republic of Tanzania). These countries have been supported by WHO to strengthen their regulatory controls o...ver antimalarial products. The survey was organized independently of manufacturers of antimalarial medicines.
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