Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusdedit K. Mubangizi
Group Lead, Inspections, WHO-PQT E-mail: mubangizid@who.int
Acknowledgements:
• Matthias Stahl
• Milan Smid
• Antony Fake
...• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
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This package of materials is designed to provide the tools necessary to begin the implementation of respectful maternity care (RMC) in your area of work or influence. Using the tools in this toolkit, one can help to change and develop attitudes in oneself and among colleagues and other stakeholders ...in the care of women and their newborns.
The components of this toolkit can be used by clinicians who are providing maternity care, trainers or educators of clinicians who will be providing maternity care, supervisors of clinicians who provide maternity care, program managers who develop and manage programs with a maternity care component, and policymakers or other key stakeholders who want to promote RMC in the programs for which they are responsible.
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J Fungi (Basel) . 2019 Aug 16;5(3):75. doi: 10.3390/jof5030075 . Namibia is a sub-Saharan country with one of the highest HIV infection rates in the world. Although care and support services are available that cater for opportunistic infections related to HIV, the main focus is narrow and predominan...tly aimed at tuberculosis. We aimed to estimate the burden of serious fungal infections in Namibia, currently unknown, based on the size of the population at risk and available epidemiological data. Data were obtained from the World Health Organization (WHO), Joint United Nations Programme on HIV/AIDS (UNAIDS), and published reports.
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The WHO COVID-19 Essential Supplies Forecasting Tool (COVID-19-ESFT) is meant to help countries forecast essential supplies for their COVID-19 response including personal protective equipment (e.g., masks and gloves), biomedical equipment for case management (e.g., ventilators and oxygen concentrato...rs), diagnostic reagents and equipment, essential drugs for supportive care, and consumable medical supplies.
The tool is best suited for estimating essential supply needs over a short time period (12 weeks or fewer) but can be used for longer.
COVID-19-ESFT does not quantify or account for resources already available locally or those pending delivery. When using the ESFT to inform procurement, we recommend factoring in resources already available locally and only including the additional resources required in the forecast.
This tool is updated regularly so users should monitor the website for the latest release version.
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La documentation et la diffusion de cette directive, des éléments de preuves et leçons émergentes seront essentielles pour mettre en œuvre les réponses les plus appropriées et efficaces face à cette pandémie.
August 2020.
Essential diagnostic products areconsidered an integral part of UHC, they are an indispensable element for delivery ofservices andare also a requirement for qualitycare. Despite this realization, a review of the UHC pilot in September 2019 es...tablished that whereas the Kenya Medical Supplies Authority (KEMSA) was able to fill up to 80% of pharmaceutical items, the order fill rate for diagnostic products was less than 50 percent for level 2 and 3 facilities and as low as 30 percent for level 4 and 5 facilities.
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6th edition. The HIV epidemic Namibia is gradually being brouhgt under countrol as demonstrated by results in the preliminary report of Namibia Population-Based HIV Impact Assessment (NAMPHIA), a cross-sectional household-based survey that was conducted in 2017. Currently, it is estimated that about... 204,207 Namibians are living with HIV. According to the NAMPHIA preliminary report, HIV prevalence among adults aged 15-64 is 12.6% and the annual HIV incidence is 0.36%. This report, together with HIV programmatic data has show that Namibia is one of the few African countries to meet the 2015 Joint United Nations Program on HIV and epidemic globally by 2030.
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Sustaining and Expanding Activities to Shift Social Norms and Care Practices for Preterm and Low Birthweight Babies.
Khanda ndi Mphatso (KnM), translated as “A Baby is a Gift”, a SBCC campaign intended to improve newborn health by shifting norms around the value of newborns and promoting Kangar...oo Mother Care (KMC) for preterm and low birthweight (PTB/LBW) babies.
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Significant progress has been made in the eradication of three priority diseases in the African Region, as a result of extensive collaboration between the Regional Office, WHO country offices and countries. For example, in August 2020, the region was certified free of wild poliovirus. In the area of... neglected tropical diseases, Guinea worm disease is on the verge of eradication, and 12 member states are within reach of being certified as having eradicated yaws by the end of this year.
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What measures can we take to overcome the corona crisis, limit its consequences or use scarce resources efficiently? Every day we experience uncertainties and contradictions on these questions among scientists, health experts, politicians and in society. We must all strive for a broad consensus to o...vercome the global COVID-19 pandemic. With our publications IM FOKUS we want to stimulate discussion and promote opinion-forming: We write based on our experience of HIV work. We are not interested in COVID-19 to be equated with HIV, but to discuss which experiences from HIV work could be helpful in dealing with COVID-19. We do not intend to replace scientific papers, nor can we present the current state of knowledge comprehensively and conclusively.
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Le Cadre stratégique de la communication pour le changement social et comportemental concernant le paludisme 2018–2030, élaboré par le Partenariat RBM, propose une approche coordonnée pour renforcer la communication dans la lutte contre le paludisme. Il vise à influencer positivement les comp...ortements individuels, communautaires et institutionnels à travers des stratégies adaptées aux contextes locaux. Le document met l’accent sur la participation communautaire, l’utilisation des données pour orienter les interventions, et la collaboration entre secteurs afin de soutenir les efforts mondiaux d’élimination du paludisme d’ici 2030.
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Frequent efforts to revise the official development assistance (ODA) accounting rules have raised important questions about the integrity and relevance of what currently “counts” as ODA spending. In this note, we outline a brief history of the evolution of the ODA accounting rules to date, highl...ighting how—and why—the ODA concept has changed since it emerged in 1969. Doing so provides a starting point for considering whether the current concept of ODA remains “fit for purpose” and whether, or how, the concept could reform to better meet current needs.
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2ieme edtion. Cette deuxième édition s'appuie sur l'expérience de plus de 10 ans de déploiement de la CPS et reflète les changements introduits dans les lignes directrices de l'OMS pour le paludisme, le 3 juin 2022. L'objectif de cette publication est de partager ces bonnes pratiques afin d'am...liorer la mise en œuvre, la couverture, le suivi et l'évaluation de la CPS. Des exemples de supports et d'outils ainsi que des liens vers des ressources sont inclus pour soutenir les responsables et les agents de santé dans leurs efforts pour mener à bien les activités de CPS et prévenir le paludisme chez les enfants vulnérables.
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Le mémoire porte sur la conception et la mise en œuvre d’une campagne de communication pour promouvoir la chimio-prévention du paludisme saisonnier (CPS) chez les enfants de 3 à 59 mois au Cameroun, une stratégie recommandée par l’OMS dans les zones de forte transmission saisonnière. L’...auteure part du constat que, malgré l’introduction de la CPS dans certaines régions camerounaises, sa mise en œuvre reste confrontée à une faible appropriation communautaire, à des résistances sociales et à un manque de communication adaptée.
L’objectif du travail est de concevoir une stratégie de communication sociale et comportementale visant à renforcer l’adhésion des communautés à cette intervention. Le mémoire s’appuie sur une analyse situationnelle approfondie, intégrant des données épidémiologiques, socioculturelles et communicationnelles. Il propose ensuite une campagne ciblée, articulée autour de messages clairs, de canaux adaptés (radios communautaires, agents de santé, leaders locaux) et de supports visuels compréhensibles.
La campagne vise à sensibiliser les parents, en particulier les mères, sur les avantages de la CPS, à corriger les fausses croyances, à encourager l’observance du traitement, et à renforcer la confiance envers les agents communautaires. Le document inclut un plan opérationnel, des outils de suivi-évaluation et une stratégie de pérennisation.
En conclusion, le mémoire souligne l’importance d’une communication contextualisée et participative pour améliorer la couverture et l’efficacité de la chimio-prévention du paludisme chez les enfants au Cameroun.
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WHO TRS N°1012.
Key updates include: (i) surveillance strategies, including cross-sectoral linking of systems and suitable diagnostics; (ii) the latest recommendations on human and animal immunization; (iii) palliative care in lowresource settings; (iv) risk assessment to guide management of bite... victims; and (v) a proposed process for validation and verification of countries reaching zero human deaths from rabies.
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Most of the global burden of sepsis occurs in low- and middle-income countries (LMICs), but the prevalence and etiology of sepsis in LMICs are not well understood. In particular, the lack of laboratory infrastructure in many LMICs has historically precluded an assessment of the pathogens leading to ...sepsis. A recent systematic review found that data describing antimicrobial resistance were absent for 43% of countries in Africa, and only two countries have national antimicrobial resistance plans. In addition, small studies have identified indiscriminate antibiotic use both in and out of hospital settings in sub-Saharan Africa. The absence of microbiological data and lack of antibiotic stewardship complicate sepsis management and almost certainly worsens outcomes, particularly in low-resource systems. The purpose of this study was to examine the prevalence, etiology, and outcomes of sepsis among a cohort of critically ill patients in a referral hospital of Malawi, with a focus on the prevalence of culture-confirmed bacteremia and urinary tract infections.
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Asthma is the most common noncommunicable disease in children, and among the most common in adults. According to the most recent estimates from the Global Asthma Network Phase I study, around one in 10 children and adults have symptoms of asthma and one in 20 school-aged children have severe asthma ...symptoms, with marked variations in prevalence and in prevalence trends between countries and regions of the world. The Global Burden of Disease Study estimated that asthma caused the loss of 21.6 million healthy years of life (disability-adjusted life years) and 461 069 deaths in 2019. Approximately 90% of the asthma burden of disease is borne by people living low and middle income countries (LMICs). Some countries report very high (up to 90%) rates of uncontrolled asthma. While the prevalence of asthma is highest in countries with a high Socio-Demographic Index (SDI), death rates from asthma are highest in countries with low and lower middle incomes.
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Esta investigacion construire y evalua la cascada de atención de la tuberculosis pulmonar en la población indígena del departamento del Cauca (Colombia) e identifica las brechas existentes. Este es el primer estudio en Colombia que analiza la cascada de atención de la TB en población indígena.... Lo anterior cobra relevancia para la toma de decisiones a nivel local y aporta evidencia sobre este tema.
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Current and expected problems such as ageing, increased prevalence of chronic conditions and multi-morbidity, increased emphasison healthy lifestyle and prevention, and substitution for care from hospitals by care provided in the community encourage countries worldwide to develop new models of prima...ry care delivery. Owing to the fact that many tasks do not necessarily require the knowledge and skills of a doctor, interest in using nurses to expand the capacity of the primary care workforce is increasing. Substitution of nurses for doctors is one strategy used to improve access, efficiency, and quality of care. This is the first update of the Cochrane review published in 2005.
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Cholera is an acute gastrointestinal infection caused by the bacterium Vibrio Cholerae serogroup O1 or O139, and is often linked to unsafe drinking water, lack of proper sanitation and personal hygiene. It adversely affects mostly the poor and vulnerable populations in countries, which are already d...eprived of proper health facilities and conducive environmental conditions. The disease spreads through oro-fecal transmission by the ingestion of contaminated food or water or by person-to-person contact. It has a short incubation period of 2 hours to 5 days and the number of affected cases can rapidly increase across large regions. Cholera is a significant threat to global public health leading to an estimated 3-5 million cases per year worldwide, with an annual toll of 100,000 deaths. The disease was first reported in 1817 from the Ganges Delta of India and since then the ongoing 7th pandemic has emerged from Indonesia, reached Africa in 1970 and Somalia happens to be one of the early affected countries. Over the past few decades,
Somalia has witnessed the occurrence of repeated AWD/Cholera disease outbreaks that have caused high morbidity and mortality across the country.
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