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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En esta nota técnica se explican los 20 aspectos que deben considerarse para evaluar el estado y la seguridad del equipo y los suministros de laboratorio. No se incluyen en este trabajo las instrucciones para los evaluadores de los puntos 93 (Estado y seguridad del equipo médico en las salas de op...eraciones y salas de recuperación) y 94 (Estado y seguridad del equipo de radiología e imagenología), que también forman parte del índice de seguridad hospitalaria.
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Anaemia is a global public health concern, especially afflicting adolescent girls, women 15–49 years of age, pregnant women, and children in low- and middle-income countries. WHO estimates that in 2019 30% (571 million) of women aged 15–49 years, 37% (32 million) of pregnant women, and 40% (269 ...million) of children 6–59 months of age were affected by anaemia, with the WHO African Region and South-East Asia
Region being most affected(
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This operational guide addresses important infection prevention and control (IPC) measures that should be implemented during a diphtheria outbreak and primarily addresses respiratory Corynebacterium diphtheriae (C. diphtheria).
This document provides detailed guidance on laboratory testing for suspected diphtheria cases during significant outbreaks or in low-resource settings. It aims to supplement and build on other existing WHO guidance documents on surveillance standards, diagnostics and research on Corynebacterium by p...roviding key considerations for laboratories that allow the rationalization and optimization of testing during outbreaks. The recommendations given here have been prepared by WHO in consultation with, and reviewed by, global experts with experience in laboratory analysis of Corynebacterium species and in outbreak settings, or with expertise in developing new technologies for diphtheria research and diagnosis. Unless otherwise stated, the considerations provided apply to diphtheria outbreaks caused by toxin-producing C. diphtheriae with a classical respiratory diphtheria presentation.
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The Africa Centres for Disease Control and Prevention (Africa CDC) Biosafety and Biosecurity Initiative was launched by the Africa CDC in April 2019 with the aim of strengthening the African Union (AU) Member States’ biosafety and biosecurity systems and enabling them to comply with national and i...nternational requirements for biosafety and biosecurity including the International Health Regulations (IHR) (2005), the Biological Weapons Convention (BWC), and United Nations Security Council Resolution (UNSCR) 1540 and the multi-country Global Health Security Agenda (GHSA). The World Health Organization (WHO) Joint External Evaluation (JEE) and the Global Health Security Index report confirmed the known capacity gaps in biosafety and biosecurity among Africa Union Member (AU).
The regional consultations by Africa CDC conducted between 2019-2021 highlighted the deficiency or limited availability of standardized and regionally recognized training programs in the continent, limiting biosafety and biosecurity capacity building efforts in the region. In response, Africa CDC working with AU Member States developed a home grown, implementable and accessible professional training and certification program that is both recognized and endorsed by AU Member States. The Regional Training and Certification Program for Biosafety and Biosecurity Professionals, for African Biosafety and Biosecurity Professionals (RTCP-BBP) has four (4) areas of specialization, namely
Selection, Installation, Maintenance and Certification of Biological Safety Cabinets
Biorisk Management
Design and Maintenance of Facilities Handling High Risk Pathogens (Biocontainment Engineering)
Biological Waste management
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The Africa Centres for Disease Control and Prevention (Africa CDC) Biosafety and Biosecurity Initiative was launched by the Africa CDC in April 2019 with the aim of strengthening the African Union (AU) Member States’ biosafety and biosecurity systems and enabling them to comply with national and i...nternational requirements for biosafety and biosecurity including the International Health Regulations (IHR) (2005), the Biological Weapons Convention (BWC), and United Nations Security Council Resolution (UNSCR) 1540 and the multi-country Global Health Security Agenda (GHSA). The World Health Organization (WHO) Joint External Evaluation (JEE) and the Global Health Security Index report confirmed the known capacity gaps in biosafety and biosecurity among Africa Union Member (AU).
The regional consultations by Africa CDC conducted between 2019-2021 highlighted the deficiency or limited availability of standardized and regionally recognized training programs in the continent, limiting biosafety and biosecurity capacity building efforts in the region. In response, Africa CDC working with AU Member States developed a home grown, implementable and accessible professional training and certification program that is both recognized and endorsed by AU Member States. The Regional Training and Certification Program for Biosafety and Biosecurity Professionals, for African Biosafety and Biosecurity Professionals (RTCP-BBP) has four (4) areas of specialization, namely
- Selection, Installation, Maintenance and Certification of Biological Safety Cabinets
- Biorisk Management
- Design and Maintenance of Facilities Handling High Risk Pathogens (Biocontainment Engineering)
- Biological Waste management
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The Assessment package has been developed for countries to evaluate the implementation of the WHO Standards for prosthetics and orthotics. It enables identification of areas in need of strengthening and facilitates relevant planning. The complete Assessment package consists of four components: Asses...sment guide: gives directions on how to organize and implement the assessment. Assessment tool: Excel instrument used to carry out assessments and record results.
User manual: explains how the Assessment tool should be used.
Planning document: Excel file into which the recommendations that are generated by the Assessment tool can be pasted for easy use in subsequent planning.
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Globally each year, millions of people suffer illness or lose their lives because the vaccines, medicines and diagnostic tests that they need are either unavailable or unaffordable – and this lack of access to medicine is acute in low- and middle-in-
come countries (LMICs). While the COVID-19 pan...demic laid this inequity bare, it also saw the pharmaceutical industry develop and bring new vaccines and treat- ments to market at unprecedented speed. As the world emerges from the worst
of this crisis, pharmaceutical companies are now at an important juncture, where lessons learned from the pandemic can prove pivotal in finding solutions to bridge long-standing gaps in access to medicine in LMICs.
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Through the USAID-funded Organized Network of Services for Everyone’s Health (ONSE) Activity, MSH is assisting Malawi’s National Malaria Control Program to provide high-quality malaria services at the facility and community levels in 10 districts, covering nearly a third of the country.
Our ...team in Malawi share recent results on strengthening malaria services through Outreach Training and Supportive Supervision (OTSS).
Designed to provide ongoing support to clinicians, data, and laboratory staff, OTSS combines a standardized checklist with targeted mentorship and supportive supervision to identify areas for improvement and strengthen clinical and diagnostic services in health facilities.
This webinar shares lessons learned on how the application of OTSS, as part of broader quality assurance systems, impacts staff performance and improves the provision and quality of malaria services.
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Leishmaniasis is a spectrum of disease caused by the infection of protozoan parasite Leishmania mainly affecting the antigen presenting cell of the host. The disease is although considered as neglected tropical disease still it is not completely eradicated. Majority of the issues related to the ther...apeutic approach is due to increased cytotoxicity of the drugs, less effectiveness, high cost and occurrence of drug resistance. Therefore, recent advancement in the field of parasitology has taken into consideration of the specific arms of immunity which can be triggered with the help of natural products, synthetic molecules or parasite specific ligands which helps in the restoration of host protective immunity and recovery from the infection. Therefore, in this review, we have highlighted the recent advancement in the field of Leishmania research taken into consideration of the therapeutic perspective. We have shown that apart from therapeutic potential of the available drugs and vaccination approach, the immune-therapy are emerging as the modern regime of treatment where the effectiveness of the therapy is significantly increased and making it safer and promising.
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Leishmaniasis is a complex vector-borne disease involving in its transmission several species of protozoan parasites called Leishmania, a wide variety of animal reservoirs and phlebotomine sandflies vectors. Cutaneous Leishmaniasis (CL) is the most common form of the disease, and its clinical manife...stations vary from few papules to multiple ulcers affecting the skin but also the mucous membranes, leaving permanent scars and serious disability. It is a disfiguring and stigmatizing disease that often has a devastating psychosocial and economic impact on the affected resources limited communities.
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Despite a historical association with poor tolerability, a comprehensive review on safety of antileishmanial chemotherapies is lacking. We carried out an update of a previous systematic review of all published clinical trials in visceral leishmaniasis (VL) from 1980 to 2019 to document any reported ...serious adverse events (SAEs).
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High prevalence of target diseases in rural and developing nations, increased prevalence of malnutrition across the globe, lack of hygiene and poor sanitation facilities, Migratory patterns of population, introduction of new chemical entity in the field of therapeutics, favorable government regulati...ons, and increased R&D investments are key factors contributing to high CAGR of point of care diagnostics market during the forecast period.
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Little progress has been made since the 1960s and 1970s to widen the therapeutic arsenal against Trypanosoma cruzi, the causative pathogen of Chagas disease, which remains a frustrating and perplexing infectious disease. This chapter focuses on the strategic and operational challenges in the clinica...l drug development of a novel antitrypanosomal agent for Chagas disease. The various elements that contribute to a robust assessment of treatment effect including dose selection, choice of patient population, trial methodology, endpoint measures, and regulatory perspectives are discussed. The learnings herein should serve as resource to help researchers and other stakeholders optimize their clinical development plans and speed delivery of new medicines to patients with Chagas disease.
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Chagas disease affects approximately 6 million people, mainly in Latin America. Less than 1% of affected individuals receive proper antiparasitic treatment, and current drugs are inadequate to fight the entire spectrum of the disease. Against this background, Novartis is pursuing an end-to-end appro...ach, with activity on three fronts: drug discovery, clinical research and health system strengthening.
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Coherent Market Insights has announced the addition of Chagas Disease Treatment Market 2023 Forecast Analysis by Types, Applications, Size, Share, Key Players, and Regions. a new research report to its market research archive. The Chagas Disease Treatment Market has been thoroughly researched and an...alyzed by industry experts and researchers. The industry is examined at the global, regional, and national levels. The report highlights the primary revenue stream for the estimated year, along with sales volumes, growth patterns, and major industry market dynamics. The historical data is provided, as well as a comprehensive revenue analysis for the forecast period. The report focuses on the size, share, growth status, and future trends of the Chagas Disease Treatment Market, as well as recent business developments.
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Dengue is a significant public health problem. There are four dengue virus serotypes identified; however, its diagnosis is difficult due to the existence of many viruses, bacteria, and parasites producing the same clinical presentation, being present in the same geographical area and even producing ...coinfections. Therefore, determining whether a person has, had, or is infected with dengue virus is of great importance. In order to do so, direct and indirect laboratory tests have been developed to identify the virus or part of its structure that generally detects the antibody response. These techniques are used for diagnosis, epidemiological studies, monitoring, assessment and production of vaccines and antivirals, etc. They range from the use of cell cultures, animal models, inoculation by insects, and serology tests to the use of detection molecular tests and quantification of genetic material that are described in this chapter herein, a brief explanation of this methodology, its strengths and weaknesses, and its application in the dengue research.
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