Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of high quality, safety and efficacy. SAHPRA is a
participating authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S).... PIC/S aims to develop international standards between countries and pharmaceutical inspection
authorities, to provide harmonised and constructive co-operation in the field of GMP. PIC/S affiliation is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures and inspection capacity.
more
Die Broschüre, die im Auftrag des Bundesinnenministeriums vom Bundesamt für Migration und Flüchtlinge gestaltet wurde, gibt auf rund 130 Seiten zahlreiche Tipps, die den Alltag erleichtern. Sie beinhaltet zudem eine Vielzahl von (Internet-)Adressen zu Beratungsangeboten und weiterführenden Stell...en. "Willkommen in Deutschland" ist kostenlos und kann in Deutsch, Arabisch, Bulgarisch, Englisch, Französisch, Griechisch, Italienisch, Polnisch, Portugiesisch, Rumänisch, Russisch, Spanisch und Türkisch bestellt werden
more
El grupo de Farmacovigilancia de la red Panamericana para la Armonización Farmacéutica (PARF) de la Organización Panamericana de la Salud (OPS), ha desarrollado este documento desde la visión OPS/OMS, considerando que la farmacovigilancia es un componente esencial de los programas de salud públ...ica. Se trabajó con el objetivo de facilitar el desarrollo, mejorar y fortalecer los sistemas de
farmacovigilancia en la región de las Américas y promover el ejercicio de las buenas prácticas para mejorar la seguridad del paciente y de la población de acuerdo a las necesidades de la región.
more
Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to... understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
more
Step-by-step risk management guidance for drinking-water supplies in small communities.
Le présent document expose des recommandations exhaustives de l’OMS sur les soins prénatals systématiques à l’intention des femmes enceintes et des adolescentes. Le but de ces recommandations est de compléter les directives de l’OMS existantes sur la prise en charge des complications spé...cifiques associées à la grossesse. Elles sont destinées à refléter et à répondre à la nature complexe des problèmes entourant la pratique et la délivrance des soins prénatals et à donner la priorité à la santé et au bien-être de la personne – et pas seulement à la prévention de la mortalité et de la morbidité – selon une démarche visant le respect des droits de l’homme.
more
В настоящем отчете представлены последние тенденции, выявленные по результатам исследования HBSC в отношении употребления алкоголя 15-летними подростками и поведен...ческих аспектов в Европейском регионе ВОЗ, а также отмечены гендерные и социально-экономические неравенства. Ранее тенденции представлялись по отдельности, тогда как здесь впервые сведен воедино более широкий диапазон данных HBSC о поведенческих аспектах употребления алкоголя подростками в целях проведения анализа новейших фактических данных и рассмотрения различий в употреблении алкоголя в зависимости от гендерной принадлежности, социально-экономического положения и географического субрегиона.
more
В этом документе представлены временные рекомендации для лабораторий и других заинтересованных сторон,
принимающих участие в диагностической работе для выявлен...ия коронавируса тяжелого острого респираторного
синдрома – 2 (SARS-CoV-2). В нем освещены основные соображения касательно взятия биологических образцов,
применения методов амплификации нуклеиновых кислот (МАНК), определения антигенов (Аг) и антител (Ат), а также
обеспечения качества.
more
Fünfte zivilgesellschaftliche Bestandsaufnahme des politischen und
finanziellen Engagements der Bundesregierung für die UN-Ziele
zur weltweiten Gesundheitsversorgung und HIV-Bewältigung
Este relatório apresenta informações sobre o conhecimento, atitutes e comportamentos em relação ao HIV/SIDA, a prevalência da malária e de indicadores básicos de saúde da mulher e da criança em Moçambique, tal como recolhida através do IMASIDA 2015 que foi realizado no âmbito do program...a de Inquéritos Demográficos e de Saúde.
more
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...n, which should provide an operational guide for countries that are restructuring mental health services and moving toward the deinstitutionalization of psychiatric care.
more
Rwanda Guidelines for variation to registered pharmaceutical products.
Perspectivas sobre las drogas
This publication is part of WHO 75th anniversary and aims to capture key successes in public health globally and in Namibia. It includes contributory messages from the Head of State, Prime Minister and the Minister of Health and Social Services.
Hinweise und Wissenswertes für ehren- und hauptamtliche Ünterstzung von Flüchtlingen. Die Broschüre des Flüchtlingsrats klärt zum einen über Fluchtursachen und Fluchtwege auf. Sie erklärt außerdem die wichtigsten Details des Asylrechts, von Anhörungen über Residenzpflicht bis hin zu Härt...efallanträgen. Und sie informiert über die Möglichkeiten und Grenzen der ehrenamtlichen Unterstützung.
more
SARS-CoV-2 infections among children and adolescents cause less severe illness and fewer deaths compared to adults. While a less severe course of infection is a positive outcome, there are concerns that mild symptoms may have led to less testing, resulting in fewer identified cases of COVID-19 in ch...ildren. If children with mild or no symptoms transmit the disease, they may act as drivers of transmission within their communities. Understanding symptoms, infectivity and patterns of SARS-CoV-2 transmission in children and adolescents is essential for developing, adapting and improving control measures for COVID-19 across all ages. This is a summary of the current knowledge around SARS-CoV-2 infection acquisition and transmission and COVID-19 disease symptoms in children and adolescents. It aims to inform decisions, based on local contexts, on how to best keep schools, kindergarten and day-care facilities open and what advice to apply to intergenerational mixing.
more