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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The indicators and questions in this document are designed for use by national AIDS programmes and partners to assess the state of a country’s HIV and AIDS response, and to measure progress towards achieving national HIV targets. Countries are encouraged to integrate these indicators and questions... into their ongoing monitoring efforts and to report comprehensive national data through the Global AIDS Monitoring (GAM) process. In this way they will contribute to improving understanding of the global response to the HIV epidemic, including progress that has been made towards achieving the commitments and global targets set out in the new United Nations Political Declaration on HIV and AIDS: Ending Inequalities and Getting on Track to End AIDS by 2030, adopted in June 2021, and the linked Sustainable Development Goals.
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Several countries have demonstrated that COVID-19 transmission from one person to another can be slowed or stopped. This document has been prepared based on the evidence currently available about Coronavirus disease 2019 (COVID-19) transmission (human-to-human transmission primarily via respiratory... droplets from, or direct contact with, an infected person), and is designed to ensure that the accommodation sector can protect the health of its staff and clients.
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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 guide décrit les étapes essentielles et donne des orientations aux pays pour l’adoption et le déploiement du c-TPIg de manière à l’intégrer dans le système de santé existant. Il s’appuie sur les meilleures pratiques et les enseignements tirés des expériences pilotes dans 8 pays af...ricains et vise toutes les acteurs impliqués dans la prestation des services pour la mère et l’enfant - responsables politiques nationaux et locaux et acteurs de mise en œuvre des programmes de lutte contre le paludisme, de la santé maternelle, de la santé de l’enfant, de la santé reproductive, des programmes de santé communautaires - ainsi que les organisations non gouvernementales et d’autres organismes. Les pays décidant d’introduire le c-TPIg sont invités à adapter ces orientations à leurs contextes nationaux et locaux.
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Trop. Med. Infect. Dis. 2022, 7, 152. https://doi.org/10.3390/tropicalmed7080152
This Implementation Kit (I-Kit), developed by the Health Communication Capacity Collaborative (HC3), which is funded by USAID and based at the Johns Hopkins Center for Communication Programs, offers structured guidance for improving social and behavioural change communication (SBCC) strategies relat...ed to malaria in pregnancy (MiP). Designed for programme managers and stakeholders, the toolkit addresses critical communication gaps in MiP programming, particularly among service providers. It provides tools to help users integrate MiP into situation analyses, segment audiences, define behavioural objectives and draft strategic communication plans.
MiP poses a significant public health challenge, contributing to maternal and neonatal mortality and morbidity in sub-Saharan Africa. Although effective interventions exist, such as the use of insecticide-treated nets, intermittent preventive treatment in pregnancy (IPTp) and timely diagnosis and treatment, their implementation remains inconsistent. The I-Kit supports more effective SBCC planning and implementation, with the aim of increasing the uptake and impact of these interventions and ultimately reducing malaria-related deaths and illness among pregnant women and newborns.
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This Implementation Kit (I-Kit), developed by the Health Communication Capacity Collaborative (HC3), helps national and local stakeholders to design country-specific social and behavioural change communication (SBCC) campaigns that address the threat posed by substandard, spurious, falsified and fal...sely labelled (SSFFC) malaria medicines. These poor-quality medicines endanger lives by failing to treat malaria effectively, undermine health systems, and contribute to drug resistance.
The I-Kit provides practical guidance and resources in six sections, including global examples, campaign design elements, media engagement strategies and tools for knowledge sharing. It is intended for health promotion officers, drug regulators, communication specialists and global health partners. Drawing heavily on experiences in Nigeria, the I-Kit promotes evidence-based, context-sensitive SBCC interventions to safeguard communities against SSFFC malaria medicines and enhance treatment outcomes.
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Community led-monitoring is based on the principle that «Nothing that is done for us should
be done without us”. The combination of this principle with evidence shows that community-led
monitoring is an important driver of improved service delivery and health outcomes that needs to
be re-empha...sized. Thus, the community must participate at all stages of the fight against malaria.
This guide will be useful to CSOs working in the field of malaria in the conduct of community-led
monitoring of activities efficiently and allow these CSOs to know their role and responsibilities in this
exercise at each key stage. This guide will also provide CSOs and communities affected by malaria
with templates of monitoring tools adapted to key malaria programs.
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Vector control, alongside case management, remains the most effective approach to controlling and eliminating malaria. Key interventions, such as indoor residual spraying (IRS) and long-lasting insecticidal nets (LLINs), have significantly reduced malaria transmission in many African countries. This... has enabled some countries to transition from the control phase to the elimination phase.
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O Manual para aplicação de borrifação residual em áreas urbanas para o controle do Aedes aegypti não se dirige apenas ao pessoal operacional e aos gerentes e gestores de nível médio dos programas de prevenção e controle das doenças transmitidas pelo Aedes, mas também à comunidade acadê...mica ligada à pesquisa operacional sobre BRI-Aedes, aos controladores de pragas privados e ao público em geral.
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National tuberculosis (TB) prevalence surveys provide a nationally representative measurement of the burden of TB disease in the population, at a given point in time. Repeat surveys allow assessment of trends and tracking of progress towards national and global targets for reductions in TB disease b...urden. Survey data also provide important insights that can help national TB programmes to identify ways to improve TB diagnosis and treatment.
National TB prevalence surveys are relevant in countries that do not yet have national disease notification and vital registration systems that are of sufficiently high quality and coverage to allow reliable tracking of TB disease burden.
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Integrated Outbreak Analytics (IOA) applies a multidisciplinary approach to understanding outbreak dynamics and to inform outbreak response. It aims to drive comprehensive, accountable, and effective public health and clinical strategies by enabling communities, and national and subnational health a...uthorities to use data for operational decision-making. IOA embraces a holistic perspective of outbreak dynamics throughout: from the trigger questions to the data that are collected or accessed, to the interpretation of results and the recommendations that follow. In addition, IOA promotes co-development and monitoring of evidence informed actions.
The IOA toolkit aims to provide a clear understanding of IOA and highlight the importance of using an integrated, holistic approach to manage outbreak responses. It provides step-by-step guidance for setting up IOA and putting IOA principles into action. Finally, this toolkit provides guidance on applying IOA in humanitarian and emergency contexts, offering a practical and adaptable approach to informing public health emergency responses.
Developed based on the model from the Democratic Republic of the Congo (DRC), its creation involved extensive consultation with experts experienced in IOA applications. The toolkit was piloted in Tanganyika Province, DRC, as well as Somalia and Sudan, demonstrating its adaptability to diverse emergency scenarios. It builds upon an existing array of tools, templates, reports, case studies, animations, and publications used by stakeholders in diverse contexts.
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Guide pour les pays à faibles revenus.
Die aktuellen Leitlinien stellen detailliert und umfassend die gesamte wissen-
schaftliche Basis und die daraus abgeleiteten Therapieempfehlungen in elf Einzel-
kapiteln dar. Darunter befinden sich auch allgemeingültige Empfehlungen wie
zum Beispiel zur Ausbildung und zu ethischen Fragestellunge...n am Lebensende.
Um Ihnen einen möglichst schnellen und gleichzeitig umfassenden Überblick zu
ermöglichen, haben wir für Sie in diesem Taschenbuch die wesentlichen Aussagen
aus allen Kapiteln als Kurzfassung zusammengestellt.
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This Course for Service Providers on how to give Vitamin A Supplementation and Deworming (VAS+D) uses both a Learner’sGuide and a Facilitator’s Guide. The Learner’s Guide is designed for participants in the course who are healthcare workers or trainers learning to deliver vitamin A and Albenda...zole(for deworming) as part of regular activities associated with community or facility-based health care services, while the Facilitator’s Guide is designed for course facilitators who are planning and conducting courses .
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