This manual describes some of the strategic, managerial, financial, technical and scientific aspects to be considered in establishing a national EQA programme for clinical laboratories and other testing services at all health care levels
Drugs, Diagnostics, Vaccines, Preventive Technologies, Research toward a cure, and immune-based and gene therapies in development
This compendium collates current tools and resources on quality improvement developed by the WHO Service Delivery and Safety Department and provides examples of how the tools and resources have been applied in country settings. The target audience for this document are ministries of health, facility... quality improvement teams, researchers and development agencies. WHO technical programmes, regional and country offices can also use the document in their technical cooperation work with the identified audience. Those working to improve the quality of health service delivery can also make good use of this resource
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Prepared as an outcome of ICMR Expert Group on Immunophenotyping of Hematolymphoid Neoplasms | Coordinated by Division of Non Communicable Diseases | This document addresses on various issue related to good quality practices in laboratory work up of flow cytometric immunophenotyping and will be of u...se to pathologists, cytometrists, hematologists, technologists and scientists working in this field.
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The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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The Ministry of Health together with its partners realizes that efficient and effective
delivery of clinical care is highly dependent on the availability of appropriately
upgraded environment, which is in well facilitated space. Such facilities and utilities
should always be properly designed, bu...ilt, and maintained, so as to ensure efficient
treatment in clean and safe from infection.
The main challenges in achieving this include the lack of, appropriate holistic and
futuristic management plans, human resource for facility/utility management and
maintenance, adequate budget funds for renovation/maintenance activities at all
levels which means daily and long-term of facility maintenance plans and executions.
It is hoped that the guidelines will help to standardise
design of medical facilities and utilities country wide and result in efficient and
effective establishment of these life-saving function
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Interim Assessement Report
The EMA review was started by the Agency’s Committee for Medicinal Products for Human Use (CHMP) to support decision-making by health authorities. This first interim report includes information on seven experimental medicines intended for the treatment of people infecte...d with the Ebola virus:
BCX4430 (Biocryst);
Brincidofovir (Chimerix);
Favipiravir (Fujifilm Corporation/Toyama);
TKM-100802 (Tekmira);
AVI-7537 (Sarepta);
ZMapp (Leafbio Inc.);
Anti-Ebola F(ab’)2 (Fab’entech).
The amount of information available for the seven treatments is highly variable. For some compounds there is no data from use in human subjects available. A small number of treatments have been administered to patients in the current Ebola outbreak as compassionate use. Finally, there are also medicines included in this review that have already been studied in humans, albeit for the treatment of other viral diseases.
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The WHO South-East Asia (SEA) Region bears a high burden of tuberculosis (TB) and MDR-TB. In 2015, the Region accounted for nearly 200 000 or 35% of the global estimated new RR/MDR-TB cases eligible for treatment. Extensively drug-resistant TB (XDRTB) has also been reported from s...ix countries of the SEA Region. MDR-TB could potentially replace drug-susceptible TB, and constitutes a threat to global public health security. The South- East Asia Regional Response Framework for DR-TB 2017–2021 complements the Ending TB in the South-East Asia Region: Regional Strategic Plan 2016–2020” and outlines key strategies for reducing morbidity, mortality and transmission of DR-TB.
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Guidelines for the registration of microbial, botanical and semiochemical pest control agents for plant protection and public health uses.
These guidelines are intended to guide pesticide regulatory authorities in the registration of microbial, botanical, and semiochemical pest control agents for p...lant protection and public health uses.
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Replacement of Annex 2 of WHO Technical Report Series, No. 964... morbidity. These preparations are included in the WHO List of Essential Medicines and should be part of any primary health care package where snakebites occur. Currently, there is an urgent need to ensure availability of safe, effective and affordable antivenoms, particularly to those in developing countries and to improve the regulatory control over the manufacture, import and sale of antivenoms.>
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This document provides a generic model that can be used for risk assessment of exposure to insecticide products applied as indoor residual sprays. It aims to harmonize the risk assessment of such insecticides for public health use in order to generate comparable data for their registering and labell...ing by national regulatory authorities. The assessment considers both adults and children (all age groups) as well as people in the following specific categories:
- those preparing the spray;
- those applying the spray;
- residents living in the treated houses;
- residents who participate in preparing and applying insecticides.
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The International Pharmaceutical Federation (FIP) is a global federation of national associations of pharmacists and
pharmaceutical scientists. In order to support these associations in their fight against AMR, FIP has prepared this
briefing document. It is an overview of the different activities ...that community and hospital pharmacists are involved
into prevent AMR and to reverse AMR rates.
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Scientists have known for more than half a century that patients could develop resistance to the drugs used to treat them. Alexander Fleming, who is credited with creating the first antibiotic, penicillin, in 1928, cautioned of the impending crisis while accepting his Nobel prize in 1945: “There ...is the danger that the ignorant man may easily underdose himself and by exposing his microbes to non-lethal quantities of the drug make them resistant.” Since then antibiotics have proved one of the most effective interventions in human medicine. Sadly, the overuse and misuse of this precious resource have brought us to a global crisis of antimicrobial resistance (AMR). To address this crisis nearly seven decades after Fleming’s lecture the first UN general assembly meeting on drug resistance bacteria was convened in September 2017.
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Intensive Care Med (2009) 35:9–29DOI 10.1007/s00134-008-1336-9
Although thousands of papers have been devoted tohospital-acquired pneumonia (HAP), many controversiesremain, and management of HAP is probably often sub-optimal. Several reviews or guidelines have been pub-lished rec...ently, mostly by North American initiatives(CDC, ATS). Three European Societies (ERS, ESCMID andESICM) were interested in producing a document thatcould complement in some way the last IDSA/ATS guidelines published 3 years ago. In addition, the Helics
working group supported this initiative.
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The current document is anupdate of the guidelines developed by the EUCAST subcommittee on detection of resistance mechanisms. The EUCAST Steering Committee has carried out the current update. The document has been developed mainly for routine use in clinical laboratories and doesnot cover technical... procedures for identification of resistance mechanisms at a molecular level by reference or expert laboratories. However, much of the content is also applicable tonational reference laboratories. Furthermore, it is important to note that the document does not cover screening for asymptomatic carriage (colonization) of multidrug-resistant microorganismsor direct detectionof resistancein clinical samples.
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The European Commission against Racism and Intolerance (ECRI) was established by the Council of Europe. It is an independent body which ensures respect for human rights in the fight against racism, discrimination (based on "race", ethnic/national origin, colour, nationality, religion, language, sexu...al orientation and gender identity), xenophobia, anti-Semitism and intolerance. The members of the Commission shall be independent and impartial. They shall be appointed on the basis of their moral authority and recognised expertise in matters of racism, xenophobia, anti-Semitism and intolerance. As part of its statutory mandate, ECRI produces country reports for each country which analyse the situation regarding racism and intolerance in each member State of the Council of Europe and make proposals to resolve the problems identified.
Translated with www.DeepL.com/Translator (free version)
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HIV-1 drug resistance (HIVDR) genotyping is an essential component of the WHO global HIVDR surveillance strategy. Plasma “gold standard” specimen type for HIVDR genotyping, but its use may not be feasible in rural, remote areas in low- and middle-income countries, since preparing and storing it ...require personnel and laboratory infrastructure that are often lacking. An alternative specimen type is dried blood spots (DBS), which can be made without special laboratory processing. DBS are more easily transported than plasma because they can be shipped at ambient temperature as non-hazardous materials using regular mail or courier services.
3rd edition
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22 December 2020
The COVID-19 vaccine safety guidance manual has been developed upon recommendation and guidance of GACVS members, as well as by experts incorporating current and available information critical to all stakeholders when COVID-19 vaccines will be introduced.
For ease of use, the man...ual is available in a compiled form and in several separate modules that can be consulted individually. For each module, specific training material is also available to facilitate implementation.
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Modern healthcare has given rise to extremely complex and multifaceted ethical dilemmas. All too often physicians are unprepared to manage these competently. This publication is specifically structured to reinforce and strengthen the ethical mindset and prac...tice of physicians and provide tools to find ethical solutions to these dilemmas. It is not a list of “rights and wrongs” but an attempt to sensitise the conscience of the physician, which is the basis for all sound and ethical decision-making. To this end, you will find several case studies in the book, which are intended to foster individual ethical reflection as well as discussion within team settings.
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These guidelines provide a framework for effective action to facilitate access to safe and ethical
testing services for different population groups. The implementation of the a comprehensive
approach, known as HIV Testing Services (HTS) is cardinal as an effective package of services
that diminis...hes the impact of the HIV epidemic in our country. All forms of HTS adhere to
the 5Cs: Confidentiality, Counselling, Consent, Correct results and Connection, or linkage
to care, with all based within a human right context. In addition to the 5Cs, however, the
MOHCDGEC emphasizes the use of a variety of approaches to HTS that will reduce the
number of missed opportunities. These include Provider-Initiated Testing and Counselling
testing, Couple counselling and testing, Index testing, and infant and children counselling and
testing in alignment to the revised WHO guidelines. Furthermore, these guidelines accentuate
on the continual provision of integrated HTS service at all levels of the public and private
health service delivery system.
The HTS Providers, managers and other stakeholders
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