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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Technical report
February 2015
Building laboratory testing capacity
Training for staff working at DR-TB management centres.
Training modules
Weekly Epidemiological Record (WER), 17 September 2021, Vol. 96, No. 37 (pp. 445-460)
This document contains summary information on the latest projections from the IHME model on COVID-19
in Brazil. The model was run on July 15, 2022, with data through July 13, 2022.
This document sets out key messages to support malaria prevention and control efforts, for teachers, pupils and the wider community. It is designed to facilitate health education in schools by encouraging teachers to guide pupils through the core messages about malaria and emphasise the most importa...nt points. Pupils are expected to actively engage by taking notes and applying what they learn. Ultimately, the goal is to equip children with the practical knowledge to influence behavioural change at both the individual and community levels.
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The WHO guidelines for malaria bring together the Organization’s most up-to-date recommendations for malaria in one user-friendly and easy-to-navigate online platform.
The WHO guidelines for malaria bring together the Organization’s most up-to-date recommendations for malaria in one user-frie...ndly and easy-to-navigate online platform. The Guidelines supersedes 2 previous WHO publications: the Guidelines for the treatment of malaria, third edition and the Guidelines for malaria vector control. Recommendations on malaria will continue to be reviewed and, where appropriate, updated based on the latest available evidence. Any updated recommendations will always display the date of the most recent revision in the MAGICapp platform. With each update, a new PDF version of the consolidated guidelines will also be available for download on the WHO website.
This version of the Guidelines includes an updated recommendation for malaria vaccines, new recommendations on the use of near-patients qualitative and semiquantitative G6PD tests to guide anti-relapse treatment of P. vivax and P. ovale, updated recommendations on primaquine and the recommendation on the use of tafenoquine. It replaces the versions published on 16 February 2021, 13 July 2021, 18 February 2022, 31 March 2022, 3 June 2022, 25 November 2022, 14 March 2023 and 16 October 2023.
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This second edition of the Basic Malaria Microscopy package is a stand-alone product,
providing all that is needed to conduct a complete training course
Anopheles stephensi is an invasive mosquito species which has been found spreading across Africa. While this species presents a new challenge for malaria control on the continent, its surveillance and management have been ongoing in Asia for many years. This document aims to summarize key lessons fr...om 3 countries – India, the Islamic Republic of Iran and Sri Lanka – that have been working to control An. stephensi. It is hoped that their experiences and insights will be valuable for countries encountering An. stephensi for the first time.
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2nd edition. The purpose of this document is to present updated standardized protocols that P. falciparum-endemic countries can use to determine the prevalence of parasites with pfhrp2/3 gene deletions causing negative HRP2 RDT results among symptomatic falciparum patients. The findings should be us...ed to guide RDT selection; more specifically when to shift away from exclusive use of HRP2 to detect P. falciparum infections.
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The WHO susceptibility test kit has been extensively used for monitoring of insecticide resistance in disease vectors for many years. Over the years, users have reported issues with these kits and potential improvements to WHO in an ad-hoc manner. To systematically determine whether the reported iss...ues were widespread and to collate potential improvements to the kit, a survey of users was put online from 30 June to 15 October 2023. The results from this survey are reported in this report.
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The aim of this protocol is to support the conduct of entomological comparative efficacy assessments for vector control products and the associated non-inferiority analysis. This evidence is used to inform discussions within the guidelines development context as to whether a new vector control prod...uct should be considered as covered by one or more existing WHO recommendations or not. Alternatively, the evidence may inform the extension of an existing WHO recommendation or the development of a new one, provided that non-inferiority is demonstrated
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Effective surveillance and monitoring of noncommunicable diseases (NCDs) and their risk factors are essential for informing evidence-based public health policies, addressing health inequities, and ensuring progress toward global and regional targets. By tracking trends in NCDs, their modifiable risk... factors such as tobacco use, unhealthy diets, physical inactivity, harmful use of alcohol, and air pollution, along with biological risk factors such as overweight and obesity, high blood pressure (hypertension), and elevated blood glucose (diabetes), policymakers can identify emerging threats, target vulnerable populations, allocating resources efficiently. Reliable data also enable countries to evaluate interventions, adjust policies, and strengthen health systems to reduce the burden of NCDs.
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Las enfermedades no transmisibles (ENT) (por ejemplo, las enfermedades cardiovasculares, el cáncer, la diabetes y las enfermedades respiratorias crónicas) y los problemas de salud mental (por ejemplo, la enfermedad de Alzheimer y las demencias relacionadas, la depresión, la ansiedad y los trastor...nos del espectro autista) son la principal causa mundial de enfermedades prevenibles, discapacidad y muerte. En este informe se examinan los riesgos que plantean las actuales tasas crecientes de ENT y problemas de salud mental en América del Sur, más allá de los riesgos para la salud, y se ponen de manifiesto sus considerables efectos negativos en el crecimiento económico. Se concibió un modelo analítico que proyecta los efectos macroeconómicos de las ENT y los problemas de salud mental durante el período 2020-2050 en 10 países de América del Sur: Argentina, Bolivia (Estado Plurinacional de), Brasil, Chile, Colombia, Ecuador, Paraguay, Perú, Uruguay y Venezuela (República Bolivariana de). Los resultados revelan que el impacto macroeconómico de las ENT y los problemas de salud mental en América del Sur se traduce en déficits económicos importantes. En términos generales, la pérdida total de PIB en América del Sur asciende a US$ 7,3 billones (US$ internacionales del 2022) en el período 2020-2050, lo que equivale al 4% del PIB total de la región. Es decir, si se eliminaran estas enfermedades y problemas, el PIB anual sería cerca de un 4% mayor cada año durante 30 años
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This publication provides an overview of evidence and guidance on the growing challenge of workplace heat stress in the context of climate change. It highlights the health and productivity risks faced by billions of workers, especially in manual labor sectors. The report details the physiological, s...ocioeconomic, and mental health impacts of heat stress and outlines evidence-based strategies for prevention and mitigation. It emphasizes the need for occupational heat action programmes, stakeholder collaboration, and tailored interventions to protect vulnerable workers, reduce productivity losses, and support sustainable development in a warming world.
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