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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.
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8 March 2022
A very large number of people from Ukraine are fleeing the country and entering the European Union (EU) countries bordering Ukraine (Hungary, Poland, Romania, Slovakia) and the EU-neighbourhood country of the Republic of Moldova. Those fleeing Ukraine - mainly women and children - are
...
currently dispersing into communities, but as more people congregate at border crossings it is likely that they will also need to be housed in reception centres.
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Research Report
The purpose of this document is to guide clinicians in the care of patients with or at risk of severe illness from influenza virus infection, including those caused by seasonal influenza viruses, pandemic influenza viruses and zoonotic (novel influenza A) viruses.
The 20th century was a period of unprecedented ecological change, with dramatic reductions in natural ecosystems and biodiversity and equally dramatic increases in people and domestic animals. Never before have so many animals been kept by so many people—and never before have so many opportunities
...
existed for pathogens to pass from wild and domestic animals through the biophysical environment to affect people causing zoonotic diseases or zoonoses. The result has been a worldwide increase in emerging zoonotic
diseases, outbreaks of epidemic zoonoses as well as a rise in foodborne zoonoses globally, and a troubling persistence of neglected zoonotic diseases in poor countries.
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The main message emerging from this new comprehensive global assessment is that premature death and disease can be prevented through healthier environments – and to a significant degree. Analysing the latest data on the environment-disease nexus and the devastating impact of environmental hazards
...
and risks on global health, backed up by expert opinion, this report covers more than 100 diseases and injuries.
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Int J Hyg Environ Health. 2019 Jun; 222(5): 765–777. doi: 10.1016/j.ijheh.2019.05.004;
To develop updated estimates in response to new exposure and exposure-response data of the
burden of diarrhoea, respiratory infections, malnutrition, schistosomiasis, malaria, soil-transmitted helminth
infec
...
tions and trachoma from exposure to inadequate drinking-water, sanitation and hygiene behaviours
(WASH) with a focus on low- and middle-income countries.
more
BackgroundClimate change is one of the great challenges of our time. The consequences of climate change on exposed biological subjects, as well as on vulnerable societies, are a concern for the entire scientific community. Rising temperatures, heat waves, floods, tornadoes, hurricanes, droughts, fir
...
es, loss of forest, and glaciers, along with disappearance of rivers and desertification, can directly and indirectly cause human pathologies that are physical and mental.
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This article provides an overview of the current and projected climate change risks and impacts to mental health and provides recommendations for priority actions to address the mental health consequences of climate change.
Best Practices Report.PART 1 Primary Protection: Enhancing Health Care Resilience for a Changing Climatei Primary Protection: EnhancingU.S. Department of Health and Human Services
Environmental pollution, protection, quality and sustainability
Epidemics of infectious diseases are occurring more often, and spreading faster and further than ever, in many different regions of the world. The background factors of this threat are biological, environmental and lifestyle changes, among others. A potentially fatal combination of newly-discovered
...
diseases, and the re-emergence of many long-established ones, demands urgent responses in all countries. Planning and preparation for epidemic prevention and control are essential. The purpose of this “Managing epidemics” manual is to provide expert guidance on those responses.
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The Committee discussed the implications for preparedness for smallpox-like events reflected by the ongoing COVID-19 pandemic. The Committee noted how quickly diagnostics and vaccines could be developed and deployed when resources and political will were abundant. This rapidity was also due to the f
...
act that the genetic sequence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had been shared worldwide. It was noted that in one country SARS-CoV-2 had been reconstructed in a laboratory from the viral genome sequence before the first case of COVID-19 had been reported, highlighting the benefits of synthetic biology technologies for accelerated development of diagnostics as well as the oft-described potential risks. Lessons learned about clinical care during the COVID-19 pandemic were also discussed.
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2nd edition. These guidelines include several notable changes from the first edition. For cutaneous leishmaniasis, ketoconazole has been removed from the list of treatment options; the number of Leishmania species for which there is strong evidence for the efficacy of miltefosine has increased from
...
two to four; and the recommendation for intralesional antimonials is now strong. For mucosal leishmaniasis there is now a strong recommendation for use of pentavalent antimonials with or without oral pentoxifylline. For visceral leishmaniasis, the strong recommendations for use of pentavalent antimonials and amphotericin B deoxycholate are now conditional.
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Desde hace muchas décadas, los microbios, en particular las bacterias, se han vuelto cada vez más resistentes a diversos antimicrobianos. El aval de la Asamblea Mundial de la Salud al Plan de Acción Mundial sobre la resistencia a los antimicrobianos, en mayo de 2015, y la Declaración política d
...
e la reunión de alto nivel de la Asamblea General sobre la resistencia a los antimicrobianos, en septiembre de 2016, reconocen que la resistencia a los antimicrobianos es una amenaza para la salud pública mundial. Estas iniciativas políticas reconocen el uso excesivo e inapropiado de los antimicrobianos como el principal factor que favorece dicha resistencia, así
como la necesidad de optimizar el uso de estos medicamentos.
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The pandemic has emphasized the high risk of avoidable harm to patients, health workers, and the general public, and has identified a range of safety gaps across all core components of health systems at all levels.
The rapid review ‘Implications of the COVID-19 pandemic for patient safety’ ex
...
plores impacts that the COVID-19 pandemic did have on patient safety in terms of risks and avoidable harm, specifically in terms of diagnostic, treatment and care management related issues as well as highlights the main patterns of these implications within the broader health system context.
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The Quadripartite Organizations – the Food and Agriculture Organization of the United Nations (FAO), the United Nations Environment Programme (UNEP), the World Organisation for Animal Health (WOAH, founded as OIE), and the World Health Organization (WHO) – collaborate to drive the change and tra
...
nsformation required to mitigate the impact of current and future health challenges at the human–animal– plant–environment interface at global, regional and country level.
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