The MSF qualification scheme is concerned with the pharmaceutical quality assessment for drugs. This procedure is applicable to products for international supply, i.e. products supplied through the MSF procurement centres. This qualification procedure is not applicable for local purchase, i.e. purch...ase of drugs within the project countries. For quality assurance principles and assessment of drugs for local purchase refer to the guideline for local pharmaceutical market assessment.
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The current guidelines on Integrated Management of Acute Malnutrition (IMAM), addresses the issue of improved management of severe acute malnutrition (SAM), particularly in children under 5 years of age. In the absence of standard protocols, mortality in children admitted to hospital with SAM can ra...nge between 20 -30% with the highest levels of 50-60% among those with oedematous malnutrition. With modern treatment regimens and improved access to treatment, case-fatality rates can be reduced to less than 5%. These provincial guidelines on IMAM in KZN, includes inpatient care protocols on the management of SAM, and outpatient and community outreach components to manage moderate acute malnutrition (MAM) and prevent deterioration to SAM.
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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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Guidance for the preparation and submission of dossiers
Основные аспекты обеспечения биологической безопасности в лабораторных условиях в связи с распространением вируса SARS-CoV
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...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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The latest update (28 January 2021) includes the following addition and revision:
biosafety aspects for working with antigen-detecting rapid diagnostic test;
handling new variants of SARS-CoV-2 in the laboratory;
updated assay decontamination before disposal;
personal protectiv...e equipment (PPE) for specimen collection;
addressing chemical hazards and their safe disposal; and
the fourth edition of the WHO Laboratory Biosafety Manual (LBM4) is now available and the terminology in this guidance was aligned with the LBM4.
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Biosafety involves the implementation of containment principles, technologies and practices to prevent unintentional exposure to biological agents. Biosecurity involves the protection, control and accountability of biological materials and information related to these materials and dualuse research,... to prevent their unauthorized access, loss, theft, misuse, diversion or intentional release.
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A global Review of evidence and practice
L’ampleur de la résistance aux insecticides chez les vecteurs du paludisme met en péril l’efficacité des programmes de lutte anti-vectorielle. Si cette résistance n’est pas atténuée, le taux de morbidité palustre va s’accroître, entraînant une hausse significative des coûts liés ... la prévention de la maladie. Ce nouveau cadre est un guide pour l’élaboration d’un plan national de suivi et de gestion de la résistance aux insecticides chez les vecteurs du paludisme, lequel doit considéré comme partie intégrante du plan stratégique national de lutte contre le paludisme.
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This report presents the findings from the Community Based Volunteers Skill Audit Survey that was carried out in 11 districts in Zambia as part of the Millennium Development Goal Acceleration Initiative.
Antimalarial drug resistance has emerged as a threat to global malaria control efforts, particularly in the Greater Mekong subregion. Drawing on data collected through more than 1000 therapeutic efficacy studies as well as molecular marker studies of Plasmodium falciparum drug resistance, the Report... on antimalarial drug efficacy, resistance and response: 10 years of surveillance (2010–2019) presents a decade’s worth of data on drug efficacy and surveillance, as well as recommendations to monitor and protect the efficacy of malaria treatment in the decades to come.
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