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 booklet provides latest available estimates of the prevalence of depression and other common mental disorders at the global and regional level, together with data concerning the consequences of these disorders in terms of lost health.
An overview of validation structures and responsibilities at national, regional and global levels.
This governance document supplements the global guidance document. Validation of elimination requires rigorous assessment at the national, regional and global levels of the impact and process indicato...rs and the fulfilment of the four foundational requirements for (1) data quality, (2) strong programmes, (3) laboratory quality and (4) human rights, gender equality and community engagement.
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Resource platform.
The Global Atlas of medical devices (GAMD) provides global, regional and country data on availability of:
national policy on health technology
regulation of medical devices
health technology assessment national unit
health technology management
use of med...ical devices nomenclature system
national lists of priority medical devices
high cost medical equipment.
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The meeting of leprosy programme managers in the South-East (SE) Asia Region was convened by the WHO Regional Office for South-East Asia (WHO-SEARO) from 11 to 13 April 2023 in Kolkata, India. The meeting was attended by 40 participants, including 15 national focal points from nine countries, five e...xperts, partners, donors and WHO staff members, including those from the Global Leprosy Programme (GLP).
The objectives of the meeting were to:
- review the current situation and progress of leprosy elimination in the Member States;
- discuss the updates on the new guidance and tools from the Global Leprosy Programme;
- facilitate experience-sharing and catalyse discussions to identify innovative practices, solutions and remaining gaps across countries to enhance leprosy elimination activities; and
- determine priority actions and support needs for accelerating leprosy elimination in the Region.
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Conformément aux recommandations de divers comités de l’Organisation mondiale de la Santé (OMS), le Bureau régional de l’OMS pour l’Afrique a mis en place trois initiatives phares afin de permettre aux États Membres de la Région africaine de se préparer aux urgences de santé publique, ...de les détecter et d’y riposter. Ces programmes sont le fruit de consultations approfondies avec plus de 30 Ministres africains, ainsi qu’avec des acteurs techniques, des partenaires à travers le continent et des institutions régionales telles que le Centre africain de contrôle et de prévention des maladies (CDC-Afrique), dont les contributions ont façonné les activités prioritaires. Le présent rapport est le troisième rapport de synthèse trimestriel sur les progrès accomplis dans la mise en œuvre des initiatives phares.
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The National Deployment and Vaccination Plan for COVID-19 vaccines (NDVP): Standard Review Form (SRF) is an excel-based resource used by Regional Review Committees to assess NDVPs submitted to the Partners Platform. The SRF enables countries to prepare their NDVPs for the review process and supports... regions in conducting a consistent and uniform assessment of the submitted NDVPs. This resource should be used in conjunction with the National Deployment and Vaccination Plan for COVID-19 vaccines (NDVP): Submission and Review Process document.
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There is no guarantee that a successful pilot program introducing a reproductive health innovation can also be expanded successfully to the national or regional level, because the scaling-up process is complex and multilayered. This article describes how a successful pilot program to integrate the S...tandard Days Method (SDM) of family planning into existing Ministry of Health services was scaled up nationally in Rwanda.
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Conformément aux recommandations de divers comités de l’Organisation mondiale de la Santé (OMS), le Bureau régional de l’OMS pour l’Afrique a mis en place trois initiatives phares afin de permettre aux États Membres de la Région africaine de se préparer aux urgences de santé publique, ...de les détecter et d’y riposter. Ces programmes sont le fruit de consultations approfondies avec plus de 30 Ministres africains, ainsi qu’avec des acteurs techniques, des partenaires à travers le continent et des institutions régionales telles que le Centre africain de contrôle et de prévention des maladies (CDC-Afrique), dont les contributions ont façonné les activités prioritaires. Le présent rapport est le quatrième rapport de synthèse trimestriel sur les progrès accomplis dans la mise en œuvre des initiatives phares.
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This publication is an updated version of the Management of Tuberculosis and HIV Coinfection clinical protocol released in 2007 by the WHO Regional Office for Europe. It is intended for all health care workers involved in preventing, diagnosing, treating and caring for people living with TB and HIV ...in the specific settings of the WHO European Region.
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These Blended Learning Modules have been produced in collaboration with the Ethiopian Federal Ministry of Health (FMOH) and Regional Health Bureaus (RHBs) as well as a range of medical experts and health science specialists within Ethiopia. They are being used to upgrade the theoretical knowledge of... the country's 33,000 rural Health Extension Workers to that of Health Extension Practitioners and to train new entrants to the service.
The Modules are Open Educational Resources (OERs) and are free for everyone to use. You can download them as they are or adapt them to fit your specific context. The OERs cover the full range of health promotion, disease prevention, basic management and essential treatment protocols to improve and protect the health of rural communities.
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Guide for community-based management and care of people with dementia
Version 1.0
Mental Health and Substance Abuse
Division of NCD and Health through the Life-Course
World Health Organization Regional Office for the Western Pacific
High salt consumption is an important determinant of high blood pressure and reducing it would improve health outcomes by lowering cardiovascular disease and therefore death rates. Reducing salt intake has been identified as one of the most effective public health measures and is one of the leading ...targets at global, regional and national levels to reduce the burden of noncommunicable diseases. The purpose of the Dietary Salt Intake Survey in the Republic of Moldova was to establish current baseline average consumption of salt (sodium), potassium and iodine through 24-hour urinary excretion testing among a random sample of the adult population (aged 18–69 years), and to assess the knowledge, attitudes, practices and behaviour around dietary salt in order to enable more efficient planning and the implementation of an effective salt-reduction strategy in the Republic of Moldova.
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This Strategic Response Plan for the measles emergency in the WHO European Region (SRP) articulates the overall status of measles resurgence in the WHO European Region and the priority actions needed to ensure an effective response to interrupt transmission, save lives and reverse the regional trend... in case numbers.
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The microbiology laboratory database software.
WHONET is a desktop Windows application for the management and analysis of microbiology laboratory data with a particular focus on antimicrobial resistance surveillance. WHONET, available in 28 languages, supports local, national, regional, and global ...surveillance efforts in over 2,300 hospital, public health, animal health, and food laboratories in over 130 countries worldwide.
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Global and Regional View of Vaccine Acceptance and Related Behaviors.
This new interactive tool captures information on knowledge, attitudes and behaviors around vaccines, masking, testing and more from 12 million people in 115 countries.
Insights and analyses on how to use the data were written ...by researchers and social and behavior change communication experts at CCP in collaboration with WHO’s Global Outbreak Alert and Response Network. This site is intended to be used by policy makers, health officials and practitioners at national and subnational levels to better understand the behavioral drivers behind vaccine uptake, masking and physical distancing among other behaviors that affect the spread of COVID-19.
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AWaRe – a new WHO tool to help countries improve antibiotic treatment, increase access and reduce resistance. We can reduce or even reverse antibiotic resistance by using antibiotics more responsibly. But how do we do that and still ensure that patients are treated effectively?WHO has developed a ...tool to help global, regional and national decision-making on which antibiotics to use when. The tool indexes the most effective antibiotics into three groups – ACCESS, WATCH, RESERVE (AWaRe for short). Evidence shows that to optimize use of antibiotics and reduce resistance, countries should increase the proportion of ACCESS antibiotics to correspond to at least 60% of total national consumption.
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The WHO Global Tuberculosis Report 2022 provides a comprehensive and up-to-date assessment of the TB epidemic, and of progress in prevention, diagnosis and treatment of the disease, at global, regional and country levels. This is done in the context of global TB commitments, strategies and targets.
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The 2022 edition of the report is as usual, based primarily on data gathered by WHO from national ministries of health in annual rounds of data collection. In 2022, 202 countries and territories with more than 99% of the world’s population and TB cases reported data
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The WHO Global tuberculosis report 2024 provides a comprehensive and up-to-date assessment of the TB epidemic, and of progress in prevention, diagnosis and treatment of the disease, at global, regional and country levels. This is done in the context of global TB commitments, strategies and targets.
Globally, more than 3 million new cases and 10 000 deaths have been reported in the week of 26 December 2022 to 1 January 2023. This represents a reduction in weekly cases and deaths of 22% and 12%, respectively. In the last 28 days (5 December 2022 to 1 January 2023), over 14.5 million cases and ov...er 46 000 new fatalities were reported globally – an increase of 25% and 21%, respectively, compared to the previous 28 days. As of 1 January 2023, over 656 million confirmed cases and over 6.6 million deaths have been reported globally.
In this edition, we include:
The COVID-19 epidemiological update at the global and regional levels.
An update on the circulating SARS-CoV-2 variants of concern (VOCs) and Omicron subvariants under monitoring.
An update on hospitalizations and ICU admissions related to COVID-19.
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