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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,
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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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13 April 2021 Policy Brief
The document is structured into five sections. The first presents the key experiences and challenges that justify a renewal of the EPHFs. The second section updates the groundwork for the exercise of public health and provides a framework to inform the exercise of the new essential functions. The th
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ird section proposes a new integrated approach for implementing the EPHFs. The fourth section presents a new list of 11 EPHFs related to each stage of this integrated approach. Finally, in the last section, considerations are put forth to guide EPHF implementation as a means of strengthening the health sector.
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This publication summarizes the facilitators and barriers that will be encountered in the deinstitutionalization process and identifies useful and proven interventions in Latin American and Caribbean countries. Four areas of work are identified with the respective guidelines or suggestions for actio
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n, which should provide an operational guide for countries that are restructuring mental health services and moving toward the deinstitutionalization of psychiatric care.
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Abridged version. In this abridged version of the Evidence-based Clinical Practice Guidelines for the Follow-Up of at-risk neonates, we provide recommendations for the care of newborns up to 2 years of age, corresponding to the first phase of their follow-up. The recommendations are intended for all
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health sector staff responsible for the primary care of these neonates: general practitioners, family practitioners, pediatricians, neonatologists, pediatric ophthalmologists, pediatric otolaryngologists, nursing professionals, specialists in other fields, and multidisciplinary staff involved in the care process. The purpose of these guidelines is to facilitate policy implementation processes carried out by decision-makers and members of government bodies, and will also be useful for parents, mothers, and caregivers. The main topics covered by this document include the hospital discharge criteria, including screening tests; information and support for parents, mothers, and caregivers; screening at the follow-up visit, and the frequency of follow-ups until the infant is 2 years of age. These guidelines do not address matters related to nursing or comorbidities.
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WHO has developed this manual in order to strengthen the laboratory diagnosis and virological surveillance of influenza infection.
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
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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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Cárcel, derechos humanos y salud pública en el contexto de la pandemia COVID-19 (Prison, Human Rights and Public Health in the context of the COVID-2019 pandemic)
Guimaraes, Alice Soares; Maclean Soruco, Enrique y Eguivar, Mario A
Revista Latinoamericana de Desarrollo Económico
(2020)
CC
Este artículo analiza un grupo particularmente vulnerable a la pandemia de la COVID-2019: las personas privadas de libertad (PPLs). Con base en el análisis del Censo Carcelario de 2019, presentamos la situación actual de las PPLs y las condiciones de los establecimient
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os penitenciarios de Bolivia, con énfasis en los aspectos que impactan en la salud. Posteriormente, identificamos los principales factores estructurales detrás de la mayor vulnerabilidad epidemiológica y sanitaria de las PPLs, no solo a la COVID-2019, sino a epidemias en general. Diferentes instituciones involucradas en el combate de la pandemia desarrollaron recomendaciones para su prevención y tratamiento en contextos carcelarios. Considerando estas recomendaciones y los datos de la situación de las PPLs de Bolivia, desarrollamos propuestas de reformas políticas y legales para reducir la vulnerabilidad epidemiológica de esta población. Argumentamos que, mientras algunas son sencillas de implementar, muchas se enfrentan a obstáculos estructurales para su ejecución, demandando reformas profundas en la política carcelaria y el sistema penal.
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La nueva hoja de ruta para poner fin a la TB en la población infantil y adolescente tiene un amplio público destinatario y alentamos a los países a que la adapten en función de su contexto nacional. Se prevé que utilicen la hoja de ruta los encargados de formular políticas a nivel nacional, re
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gional y mundial; los programas nacionales relacionados con la TB, la salud maternoinfantil, la infección por el VIH y otros programas de atención primaria de salud que formulan estrategias y planes sobre los servicios de salud. También será útil para los profesionales de salud en los servicios públicos y privados, las organizaciones de la sociedad civil y los organismos técnicos que participa
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Este documento brinda orientaciones y directrices técnicas para mantener las acciones para la prevención y control de la tuberculosis (TB), ante la coyuntura que representa la pandemia del COVID-19 en Colombia, de conformidad con las directrices y recomendaciones emitidas por la Organización Mund
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ial de la Salud (OMS), Organización Panamericana de la Salud (OPS) y demás organismos internacionales, que generan recomendaciones en la respuesta integrada a estos eventos de alto impacto para la salud pública. Estas recomendaciones están dirigidas a los diferentes agentes del sistema de salud tales como: entidades territoriales del orden departamental, municipal y distrital, empresas administradoras de planes de beneficios, prestadores de servicios de salud, trabajadores de la salud, agentes comunitarios y demás implicados en las acciones para la prevención y control de la tuberculosis y el COVID-19.
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O Protocolo de Vigilância Epidemiológica e Sanitária de Eventos Adversos Pós-Vacinação (EAPV), é o documento de referência nacional para a vigilância das vacinas COVID-19. Além disso, complementará, com os demais protocolos definidos pelo Ministério da Saúde, as ações empreendidas par
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a o enfretamento da pandemia de Covid-19 no país.
O desenvolvimento e a operacionalização do Protocolo obrigam à definição clara de uma estrutura de liderança, coordenação e harmonização, bem como à identificação das entidades com responsabilidades no planejamento, na execução e na avaliação das atividades estabelecidas nas três esferas de gestão do Sistem Unico de Saude. Para tanto, este Protocolo preconiza o fortalecimento da integração dos atores do SUS, bem como de segmentos da sociedade brasileira, envolvidos direta ou indiretamente com a minimização de riscos e monitoramento de EAPV.
Este documento apresenta orientações gerais estruturantes e procedimentos para o funcionamento eficiente do sistema de farmacovigilância/vigilância de eventos adversos pós-vacinação (VEAPV) nas diferentes esferas de gestão do Sistema Unico de Saude, especificamente quanto as questões de segurança e queixas técnicas de vacinas.
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O objetivo deste documento é definir o papel dos serviços de APS/ESF no manejo e controle da infecção COVID-19, bem como disponibilizar os instrumentos de orientação clínica para os profissionais que atuam na porta de entrada do SUS a partir da transmissão comunitária de COVID-19 no Brasil.
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Management of covid-19: a practical guideline formaternal and newborn health care providers inSub-Saharan Africa
B. N. Ezenwa, I. B. Fajolu, O. R. Akinajo, et al.
The Journal of Maternal-Fetal & Neonatal Medicine
(2020)
CC
COVID-19 is a pandemic that is currently ravaging the world. Infection rate is steadily increasingin Sub-Saharan Africa. Pregnant women and their infants may suffer severe illnesses due to theirlower immunity. This guideline prepares and equips clinicians working in the maternal and new-born section
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s in the sub-region to manage COVID-19 during pregnancy and childbir
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COVID-19 infection affects all age groups including newborns, however, literature is scarce on the fetal and neonatal outcomes of babies exposed in-utero, especially in Africa. The objectiveof this study was to document the perinatal outcomes of COVID-19 pregnancies and del
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iveries that occurredduring the pandemic in Nigeria.
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In the present report, the Special Rapporteur on the sale and sexual exploitation of children, including child prostitution, child pornography and other child sexual abuse material, Mama Fatima Singhateh, focuses on the impact of the coronavirus disease (COVID-19) p
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andemic on increased risk and various manifestations of sale and sexual exploitation of children. The Special Rapporteur outlines the push and pull factors, protection challenges and good practices, and provides recommendations on measures to address the heightened risks of sale and sexual exploitation of children, both online and offline, during and in the aftermath of the COVID-19 crisis and the ensuing lockdowns.
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The procurement of essential medicines and other health products is a critical function in support of the effective discharge of WHO’s mandate, and WHO values the importance of the quality of essential medicines and health products that are supplied to countries. The first World Health Assembly in
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1948 recognized the need to establish a procurement service at WHO, and recommended setting up an office “to give advice on the procurement of essential drugs, biological products and other medical supplies”.
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10 May 2021. Manufactureres:
SK Bioscience Co. Ltd. [COVID-19 Vaccine (ChAdOx1-S [recombinant])]
Serum Institute of India Pvt. Ltd. [COVISHIELD™, ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant)]
The ChAdOx1-S/nCoV-19 [recombinant] vaccine is a replication-deficient adenoviral vecto
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r vaccine against coronavirus disease 2019 (COVID-19). The vaccine expresses the SARS-CoV-2 spike protein gene, which instructs the host cells to produce the protein of the S-antigen unique to SARS-CoV-2, allowing the body to generate an immune response and to retain that information in memory immune cells. Efficacy shown in clinical trials in participants who received the full series of vaccine (2 doses) irrespective of interval between the doses was 63.1%, based on a median follow-up of 80 days, but tended to be higher when this interval was longer. The data reviewed at this time support the conclusion that the known and potential benefits of ChAdOx1-S/nCoV-19 [recombinant] vaccine outweigh the known and potential risks.
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5 May 2021
This Information Note is intended to assist national TB programmes and health personnel worldwide to maintain essential tuberculosis (TB) services during the COVID-19 pandemic and in the recovery phase. It is important that recent progress made in TB prevention and care is not reversed b
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y COVID-19. The WHO Global TB Programme, along with WHO regional and country offices, developed this note in response to questions received from Member States and other partners since the start of the pandemic. The note includes references to other published WHO information products relevant to TB practitioners. WHO continues to monitor the situation closely for any changes that may influence this note and will issue updates should any factors change.
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The COVID-19 Strategic Preparedness and Response Plan (SPRP) 2021 Monitoring and Evaluation Framework tracks global progress against the COVID-19 SPRP 2021 for the ten pillars of the public health response. The operational intelligence complements the epidemiologic information used to drive a global
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dynamic system of support and response. Monitoring SPRP 2021 implementation will support countries, partners and WHO in strategic thinking, operational tracking and course correction based on evidence and transparency to strengthen the response to COVID-19.
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