PQDx 0197-045-00 WHO
PQDx PR
March /2016, version 2.0
This manual provides a practical method for determining the pharmacovigilance indices. It is designed to be simple and can be understood by any worker in pharmacovigilance without formal training in monitoring and evaluation. Pharmacovigilance as a medical discipline is crucial in preventing medicin...e-related adverse effects in humans, promoting patient safety, and the rational use of medicines. The indicators proposed in this manual are based on the expected functions of pharmacovigilance centres as described in the WHO Mimimum Requirements for a Functional Pharmacovigilance System (1) (see Annex 1 of the manual).
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A Summary
Accessed: 23.11.2019
Manual Logistical Management of Humanitarian Supply
The flood of relief supplies that arrive in the aftermath of large-scale disasters often poses serious logistic and management problems for national authorities. SUMA is a tool for the management of humanitarian relief supplies, from the time pled...ges are made by donors, to their entry into the disaster area and their storage and distribution.
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Автоматизированная технология амплификации нуклеиновых кислот в режиме реального времени для быстрого и одновременного выявления туберкулеза и устойчивости к р...ифампицину: система Xpert MTB/RIF.
Программное заявление.
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The ongoing COVID-19 pandemic presents an exceptional and unprecedented challenge for competent authoritiesa with responsibilities for national food safety control systemsb to continue conducting routine functions and activities in accordance with national regulations... and international recommendations. In many countries, competent authority staff are largely working from home, teleworking being the normal practice, and all face-to-face meetings cancelled or rescheduled as teleconferences. It is challenging to maintain, without interruption, routine activities such as the inspection of food business operations, certifying exports, control of imported foods, monitoring and surveillance of the safety of the food supply chain, sampling and analysis of food, managing food incidents, providing advice on food safety and food regulations for the food industry, and communicating on food safety issues with the public.
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Текущая пандемия COVID-19 представляет собой исключительную и беспрецедентную проблему для компетентных органовa, отвечающих за работу национальных систем к...нтроля безопасности пищевых продуктовb, которая препятствует дальнейшему выполнению стандартных функций и мероприятий в соответствии с национальными правилами и международными рекомендациями.
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The frequency of infectious disease epidemics is increasing, and the role of the health sector in the management of epidemics is crucial in terms of response. In the context of infectious disease epidemics, the use of climate-informed early warning systems (EWS) has the potential to increase the eff...ectiveness of disease control by intervening before or at the beginning of the epidemic curve, instead of during the downward slope.
Currently, the initiation of interventions is heavily reliant on routine disease surveillance systems – data that often arrive too late for preventative response. However, forecasting of disease outbreaks using surveillance and weather information shows promising potential – there also remains further scope to examine seasonal climate forecasts. By combining these elements in new EWS based on computational models, it will be possible to improve both the timeliness and impact of disease control. The World Health Organization (WHO) is strengthening existing surveillance systems for infectious diseases to enable the development of more robust and timely EWS, which has resulted in the rapid development and innovation of EWS for disease outbreaks.
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Maternal mortality has fallen significantly in recent years, especially in countries that have emphasized the prevention of its main causes, such as hemorrhagic and infectious complications and hypertension , including in the Region of the Americas. In its final report on the Plan of Action to Accel...erate the Reduction of Maternal Mortality and Severe Maternal Morbidity, the Pan American Health Organization (PAHO) reported a continuing downward trend in maternal mortality, with an 18.1% reduction in the maternal morbidity ratio during the period 2010-2015 . From a pathophysiological perspective, death events are a common end result of a wide spectrum of complications leading to multi-organ dysfunction. However, there is a group of women in this situation who survive, despite the seriousness of their condition. This high number of patients––who were in serious condition
but did not die––reflects the actual health conditions in an institution or a country. For this reason, there is a need to create indicators to estimate morbidity in women due to diseases and incidents that occur during pregnancy, childbirth, and the puerperium. To this end, we propose conducting epidemiological surveillance of an indicator that includes women who survived after presenting a potentially fatal complication during pregnancy, childbirth, or the puerperium, reflecting quality medical attention and care (5, 6). This indicator
is maternal near-miss (MNM), which refers to extremely severe maternal morbidity––cases of a severity that
brings women very close to the death event. After adjusting the definition to a specific population and time,
MNM is defined as a case in which a woman nearly died, but survived a complication that occurred during
pregnancy, childbirth, or within 42 days of termination of pregnancy
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World Health Organization. (2021). Minimum technical standards and recommendations for reproductive, maternal, newborn and child health care for emergency medical teams. World Health Organization.
The Virtual cGMP Training Marathon for Vaccine Manufacturing: Principles into Practice took place from 12 Sep to 10 Oct 2023 to continue to provide manufacturers & regulators with a comprehensive array of topics to build understanding of current WHO & international GMP standards, technological advan...cements, industry practices and regulatory expectations specific to the vaccine manufacturing context. Some of the topics include computer system validation, data integrity, challenges in lyophilization and others. Real world examples and case studies will be used to show how to interpret current and recently new good manufacturing practices requirements from a practical point of view and to implement appropriate approaches.
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