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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Supplément
Décembre 2016
Services de dépistage du VIH
Live Life positively
Know your HIV status
Accessed: 03.03.2020
This guideline provides advice in regards to applications for Marketing Authorisations for antimicrobial veterinary medicinal products (VMPs) on the data required and the methodology to be used for performing an assessment of the risk to public health from antimicrobial resistance (AMR) due to use o...f the product. The scope of the guidance extends to VMPs intended for food producing species and to the transmission of AMR by the foodborne route or through direct contact with treated animals.
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Community Health Impact Coalition members & colleagues from across the world are sharing COVID-19 explainers, internal policies, clinical protocols, & more live
In May 2015, the Sixty-eighth World Health Assembly recognized the importance of the public health problem posed by antimicrobial resistance by adopting the global action plan on antimicrobial resistance (“global action plan”). The global action plan proposes interve...ntions to control antimicrobial resistance, including reducing the unnecessary use of antimicrobials in humans and in animals. The global action plan also emphasizes the need to take a cross-sectoral, “One Health” approach for controlling antimicrobial resistance, involving efforts by actors from many disciplines including human and veterinary medicine.
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interim guidance, 14 June 2021
This document is intended for national authorities and decision makers in countries that have introduced large scale public health and social measures. It offers guidance for adjusting public health and social measures, while managing the risk of a resurgence of cases....
Available in English, Arabic, Chinese, French, Russian and Spanish
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Le présent document est une mise à jour du document d’information scientifique publié le 29 mars 2020 intitulé Modes of transmission of virus causing COVID-19: implications for infection prevention and control (IPC) precaution recommendations et comprend les nouvelles don...nées scientifiques disponibles sur la transmission du SARS-COV-2, le virus responsable de la COVID-19.
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This document provides an overview of specific health care waste technologies for the treatment of solid infectious and sharp waste. For each technology, details of its operation, effects on the environment and health, requirements for installation, capacities for treating waste, examples of consuma...bles and advantages and disadvantages are described. The document is designed for health care facility administrators and planners, WASH and infection prevention control staff, national planners, donors and partners.
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Forcibly Displaced Myanmar National / Rohingya Refugee Response.
This document gives guidance for medical providers to understand the care of both healthy and COVID suspect or confirmed patients who present for antenatal (ANC), intrapartum (IP), postnatal (PNC), or emergency obstetric and neonatal ...care (EmONC) in the context of caring for the forcibly displaced Myanmar national (FDMN) / Rohingya refugee population.
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In 2016, the risk of premature mortality1 from noncommunicable diseases (NCDs) in Ethiopia was 18.3%. The economic costs of NCDs are significant and are due principally to their impact on the non-health sector (reduced workforce and productivity). In this study, it is estimated that NCDs cost Ethiop...ia at least 31.3 billion birr (US$ 1.1 billion) per year, equivalent to 1.8% of the gross domestic product (GDP). Less than 15% of the costs are for health care.
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The WHO Quality Health Services: a planning guide focuses on actions required at the national, district and facility levels to enhance quality of health services, providing guidance on implementing key activities at each of these three levels. It highlights the need for a health systems approach to ...enhance quality of care, with a common understanding on the activities needed by all stakeholders. The guide articulates the key actions required to improve the quality of health services for the entire population. It recognizes that the path varies for each country, district and facility – stimulating the reader to consider multiple factors and entry points for action. This planning guide is for staff working at all levels of the health system (i.e. national, district and facility) who have a role in enhancing the quality of health services. It is also relevant to all stakeholders initiating and supporting action at facility, district and/or national levels both in the public and private sectors.
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PlosOne January 20, 2021
https://doi.org/10.1371/journal.pone.0241899
Antibiotic fixed dose combinations (FDCs) can have clinical advantages such as improving effectiveness and adherence to therapy. However, high use of potentially inappropriate FDCs has been reported, with implications for antim...icrobial resistance (AMR) and toxicity.
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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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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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Este protocolo tem como objetivo fornecer informações aos profissionais de saúde para que a pessoa com tuberculose receba o devido acolhimento e tratamento, apresentando os fluxos indicados para as transferências dentro e fora do país.
Med Princ Pract 2021;30:17–28
An overview of ethics and clinical ethics is presented in this review. The 4 main ethical principles, that is beneficence, nonmaleficence, autonomy, and justice, are defined and explained. Informed consent, truth-telling, and confidentiality spring from the ...principle of autonomy, and each of them is discussed. In patient care situations, not infrequently, there are conflicts between ethical principles (especially between beneficence and autonomy). A four-pronged systematic approach to ethical problem-solving and several illustrative cases of conflicts are presented. Comments following the cases highlight the ethical principles involved and clarify the resolution of these conflicts. A model for patient care, with caring as its central element, that integrates ethical aspects
(intertwined with professionalism) with clinical and technical expertise desired of a physician is illustrated
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medios de diagnóstico, tratamientos y grado de preparación respecto a las vacunas y otros productos sanitarios: módulo de las evaluaciones armonizadas de la capacidad de los centros de salud en el contexto de la pandemia de COVID-19, 7 de julio de 2021