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:
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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 technical report presents results from the FEEDcities Project – Eastern Europe and Central Asia, a cross-sectional survey conducted in Almaty, Aktau and Kyzylorda, Kazakhstan, between July and August 2017, to evaluate the local street food environment. It characterized the vending sites, the
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food offered and the nutritional composition of the industrial and homemade foods available in these settings. The policy implications of the findings are outlined.
The study was conducted within a bilateral partnership between WHO and the Institute of Public Health of the University of Porto, in collaboration with the Faculty of Medicine, the Faculty of Nutrition and Food Sciences and the Faculty of Pharmacy of the University of Porto (WHO registration 2015/591370 and 2017/698514). The study was funded through a biennial collaborative agreement and joint programmes between the Government of Kazakhstan and United Nations agencies in Kazakhstan for Kyzylorda and Mangystau oblasts, a voluntary contribution by the Ministry of Health of the Russian Federation and the Resolve to Save Lives project of Bloomberg Philanthropies.
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This global guidance provided the framework for over 100 countries to develop their NDVPs. This updated (second) version supersedes the previous version published in 16 November 2020. New information has been added on the following areas:
the COVID-19 Partners Platform;
the use of COVID
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-19 simulation exercises to test deployment strategies;
the indemnity agreement and no-fault compensation programme for vaccines secured through the COVAX Facility in the Advance Market Commitment (AMC) eligible economies;
the availability and use of the WHO-UNICEF COVID-19 Vaccine Introduction and deployment Costing (CVIC) tool;
the COVAX Facility’s humanitarian buffer that enables allocation of vaccine to cover high-risk populations in humanitarian settings;
recommendations for vaccination of pregnant and lactating women;
supplementary information on infection prevention and control (IPC) measures to be used to deliver COVID-19 vaccines safely;
the WHO licensed COVID-19 vaccines product-specific information;
use of geospatial data and digital micro plans for equitable access and delivery of COVID-19 vaccines;
lessons learned from the development of NDVPs and early experiences in COVID-19 vaccine deployment in countries; and
updated additional resources at the end of each chapter.
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Prices people pay for medicines.
Interim guidance, 6 October 2021
Direct detection of SARS-CoV-2 viral proteins (antigens) in nasal swabs and other respiratory secretions using lateral flow immunoassays (also known as rapid diagnostic tests, RDTs) offers a faster and less expensive method to test for SARS-CoV-2 than the reference
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method, nucleic acid amplification tests (NAATs). This interim guidance offers recommendations on the priority uses of antigen-detecting rapid diagnostic tests (Ag-RDTs) in specific populations and settings, including (i) for primary case detection in symptomatic individuals suspected to be infected and asymptomatic individuals at high risk of COVID-19, (ii) for contact tracing, (iii) during outbreak investigations and (iv) to monitor trends of disease incidence in communities. Ag-RDTs meeting minimum performance requirements can be used outside of clinical and laboratory settings, including in communities, by trained operators in accordance with instructions. The guidance additionally provides recommendations on implementation, product selection and storage.
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A guidebook intended for use by first responders
during the initial phase of a transportation incident
involving dangerous goods/hazardous materials
This technical report describes the results of a cross-sectional survey conducted in Dushanbe, Tajikistan, between April and May 2016, as part of the FEEDcities Project – Eastern Europe and Central Asia. The aim was to describe the local street food environment: the characteristics of the vending
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sites, the food offered and the nutritional composition of the industrial and homemade foods usually consumed in these settings.
The study was part of a bilateral partnership between WHO and the Institute of Public Health of the University of Porto, Portugal, in collaboration with the Faculty of Medicine, the Faculty of Nutrition and Food Sciences and the Faculty of Pharmacy of the University of Porto (WHO registration numbers 2015/591370 and 2017/698514).
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WHO Regional Publications, Western Pacific Series No. 23
Reports the findings and recommendations of a working group convened to prepare guidelines for the use of herbal medicines in Western Pacific countries. Addressed to national health authorities, the report responds to the widespread use o
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f herbal medicine in this part of the world and the corresponding need for mechanisms to ensure that these products are safe and effective, yet remain broadly accessible. With this need in mind, the report sets out a comprehensive framework for developing national policies designed to control the safety, efficacy, and quality of herbal medicines, manufacturing practices, product registration, and labelling, marketing, and trade.
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14.04.2016
Pharm -Ed
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The alcohol-based solution for hand hygiene is now part of the WHO essential medicines list .Local production of the alcohol-based handrub is an alternative to commercial products. Although adapted to contexts with limited resources, it is essential to respect the Good Man
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ufacturing Practices to ensure the quality, efficacy and safety of the product.
If you need production sheet, checklist of the material needed etc., please click on the following link: https://pharmed.datapharma.ch/courses...
Pharm-Ed (www.Pharm-Ed.net) is an initiative of the Pharmacy of the Geneva University Hospitals in Switzerland. The platform is free but registration (for free) is needed to access the e-learning courses and resources.
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22 Sept. 2021
The rapid development of effective Covid-19 vaccines in 2020 gave hope to the world in the darkest days of the deadly pandemic. However, the vaccine roll-out has been massively skewed towards wealthy nations. While rich states have hoarded vaccines, companies have also played a decisi
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ve role in restricting fair access to a life-saving health product. This report focuses on six leading vaccine developers, AstraZeneca, BioNTech, Johnson & Johnson, Moderna, Novavax and Pfizer, assessing each company’s human rights policy, pricing structure, records on intellectual property, knowledge and technology sharing, allocation of available vaccine doses and transparency.
Available in Arabic, English, French, German and Spanish
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This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospita
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ls in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. Patients were treated with either 100 mg of pafuramidine orally twice a day for 10 days or 4 mg/kg pentamidine intramuscularly once daily for 7 days to assess the efficacy and safety of pafuramidine versus pentamidine. Pregnant and lactating women as well as adolescents were included.
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The purpose of adding the books to the website of MCAI for download, is to make this life-saving, up-to-date information available to all who need it. Fill in a short registration field and you can download the pdf-files.
If you work in a hospita
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l in a low income country - providing free care - you are probably intitled to FREE copies of these books. MCAI will send them to you, all you have to do is to read our Flyer and fill in the request form.
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Communities can play a critical role in suicide prevention. Facilitating community engagement in suicide prevention is an important task. The toolkit is a step-by-step guide for communities to engage in suicide prevention activities and have ownership of the process and keep efforts sustained. It is
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hoped that the pilot version will be used, after necessary adaptation, in many countries and contexts, so that the final product can be strengthened and become more effective and user-friendly.
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This technical report contains the results from the FEEDcities Project – Eastern Europe and Central Asia, a cross-sectional survey of the local urban food environment conducted in Chișinău, Republic of Moldova between June and August 2016. It characterizes the vending sites, the food offered and
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the nutritional composition of both industrial and homemade street foods. It also describes the nutritional composition of foods sold in supermarkets and fast-food outlets.
The study was conducted within a bilateral partnership between the World Health Organization and the Institute of Public Health of the University of Porto, in collaboration with the Faculty of Medicine, the Faculty of Nutrition and Food Sciences and the Faculty of Pharmacy of the University of Porto (WHO registration 2015/591370 and 2017/698514). The study was funded through a voluntary contribution of the Ministry of Health of the Russian Federation.
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Vulnerable and Marginalized Groups Planning Framework
This technical report presents the results of a cross-sectional survey conducted in Sarajevo, the Federation of Bosnia and Herzegovina, Bosnia and Herzegovina, between June and August 2017, as part of the FEEDcities Project (Food Environment Description in cities – eastern Europe and central Asia)
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. The aim of the report is to describe the city’s local street food and takeaway food environment, exploring the characteristics of food vending sites, the industrially produced and homemade foods they typically offer, and the nutritional composition of these foods. Finally, the report provides guidance on how to address its findings through policy action.
The study was conducted through a bilateral partnership between the World Health Organization (WHO) and the Institute of Public Health of the University of Porto, in collaboration with the Faculty of Medicine, the Faculty of Nutrition and Food Sciences, the Faculty of Pharmacy of the University of Porto (WHO registration 2015/591370 and 2017/698514) and the Institute of Public Health of the Federation of Bosnia and Herzegovina. The study was funded through a voluntary contribution of the Ministry of Health of the Russian Federation, and through a contribution made by the Swiss Agency for Development and Cooperation (SDC)/Swiss Government to a joint WHO/SDC project, “Reducing Health Risk Factors in Bosnia and Herzegovina: Developing and Advancing Modern and Sustainable Public Health Strategies, Capacities and Services to Improve Population Health”, implemented in Bosnia and Herzegovina.
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