This article is part two in a series of explainers on vaccine development and distribution. Part one focused on how vaccines work to protect our bodies from disease-carrying germs. This article focuses on the ingredients in a vaccine and the three clinical trial phases. Part three outlines the nex...t part of the vaccine journey: the steps from completing the clinical trial phases through to distribution
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These WHO interim recommendations on the use of the Pfizer – BioNTech BNT162b2 vaccine against Covid-19 were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) and the evidence summary included in the background document referenced below.
fir...st issued 8 January 2021, updated 15 June 2021, updated 19 November 2021, updated 21 January 2022, updated 18 August 2022. Available in other languages https://apps.who.int/iris/handle/10665/361720
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REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS
nterim guidance, first issued 25 January 2021, updated 15 June 2021, updated 19 November 2021, updated 23 February 2022, updated 18 August 2022
1PEP GUIDELINES | 2019 EDITION. The prevalence of both HIV and Hepatitis B is high in South Africa therefore there is a significant risk of acquiring these infections following exposure to infected material. Studies suggest that post- exposure prophylaxis (PEP) with highly active antiretroviral trea...tment (HAART) is highly effective in preventing HIV infection if taken correctly for the full recommended duration of 28 days, and that prophylaxis with Hepatitis B immunoglobulin and vaccination may prevent Hepatitis B infection if given soon after exposure. This update of the Western Cape guidelines for management of potentially infectious exposures is based on current evidence and guidelines issued by the WHO, NDoH and the SA HIV Clinicians Society. The key aim is to promote successful completion of the recommended ART regimen in the 28 day period of therapy, as well as prevent infection with Hepatitis B
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These WHO interim recommendations on the use of the Astra Zeneca – Oxford University AZD1222 vaccine against Covid-19 were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) and the evidence summary included in the background document referenc...ed below.
This document has been updated: Version 15 March 2022.
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100 test methods for 100 active pharmaceutical ingredients
For existing Minilab projects that want to replace old manuals or initiatives that want to start new projects, the new "Minilab Edition 2020" can be obtained at the preferential price of 50 € from our logistic partner Technologie Transfer... Marburg. The e-mail address is ttm@ttm-germany.de.
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Two test methods on dexamethasone tablets and injections
Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,... which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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Las recomendaciones contenidas en este módulo son un componente de las directrices unificadas de la OMS sobre la tuberculosis (TB) y están destinadas principalmente para el uso de los programas nacionales de control de la tuberculosis, los organismos de salud pública y otros interesados clave que... participan en la planificación, ejecución y seguimiento de las actividades de gestión programática de la TB farmacorresistente. El objetivo esta actualización es proporcionar información basada en la evidencia sobre determinadas áreas críticas que ayude a fundamentar el uso de nuevos esquemas totalmente orales y la posible ampliación de la ficha técnica de los nuevos medicamentos contra la TB. Los interesados directos podrán distinguir entre las recomendaciones anteriores que siguen siendo válidas, las que se han actualizado y las que se han elaborado recientemente sobre la base de estudios adicionales, teniendo en cuenta la gama de beneficios conocidos y posibles daños, los ejercicios de modelización y otros datos para fundamentar el proceso de toma de decisiones.
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These WHO interim recommendations for use of the Sinovac-CoronaVac were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) and the evidence summary included in the background document and annexes referenced below.
This document has been updat...ed: version 15 March 2022.
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This summary assesses the current state of evidence on each approach in tabular form, providing: the definition and objectives; evidence of effectiveness; operational considerations (e.g., training, staffing, and logistics); cost considerations and evidence on cost-effectiveness; operational success...es and challenges; and areas for future research and learning. This document is not intended to endorse any particular approach. Rather, it aims to objectively present the state of the existing evidence on each approach, so as to inform decision-making among practitioners looking to further test, refine and implement such approaches.
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orientations provisoires, 25 juin 2021. Des tests de diagnostic rapides et précis sont un outil essentiel pour prévenir et contrôler la propagation du COVID-19. Ce document décrit les recommandations relatives aux stratégies nationales de dépistage et à l'utilisation de la PCR et des tests an...tigéniques rapides dans différents scénarios de transmission de l'épidémie de COVID-19, y compris la manière dont les tests pourraient être rationalisés dans les milieux à faibles ressources. Tous les tests doivent être suivis d'une réponse de santé publique forte, comprenant l'isolement des personnes dont le test est positif et la fourniture de soins, la recherche des contacts et la mise en quarantaine des contacts.
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Medicines and medical devices for 10 000 people for approximately three months
These WHO interim recommendations for use of the BBV152 COVAXIN vaccine were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) and the evidence summary included in the background document and annexes referenced below.
This document has been ...updated: version 15 March 2022.
The vaccine is formulated from an inactivated SARS-CoV-2 antigen and is presented in single dose vials and multidose vials of 5, 10 and 20 doses.
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Drug Distribution and Control: Preparation and Handling
This Technical Assistance Bulletin is intended to assist pharmacists in the extemporaneous compounding of non-sterile drug products for individual patients. Included in this document is information on facilities and equipment, ingredient... selection, training, documentation and record keeping, stability and beyond-use dating, packaging and labeling, and limited batch compounding. This document is not intended for manufacturers or licensed repackagers.
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In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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This guideline aims to improve the quality of donations and the management thereof and serve as the basis for policies of the State and other organizations in the giving and receiving of donations of medicines, medical devices and IVDs.
Over the last three or four decades, there has been an enorm...ous increase in scientific knowledge about the mode of action, effects and side effects of medicines, medical devices and IVDs. It is important for all
stakeholders to understand that these products have both benefits and risks, that they have to be used carefully and appropriately and that some can do more harm than good.
There are many different scenarios for the donation of medicines, medical devices and IVDs. Donations may take place in acute emergencies or as part of development aid in non-emergency situations. They may involve donations (i.e. direct or through private voluntary organizations), aid by governments or persons authorized to sell medicines, medical devices and/or IVDs.
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