2nd edition. WHO's recommendation has not changed: the standard WHO susceptibility tests should remain a primary method by which resistance is detected. However, it was considered necessary to update the existing resistance-monitoring procedures to also highlight the need for operationally meaningfu...l data.
Two new assays were included in this expanded version: an intensity assay and a synergist assay.
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Claims for refugee status related to situations of armed conflict and violence under Article 1A(2) of the 1951 Convention and/or 1967 Protocol relating to the Status of Refugees and the regional refugee definitions
UNHCR issues these Guidelines on International Protection pursuant to its mandate,... as contained in, inter alia, the Statute of the Office of the United Nations High Commissioner for Refugees, namely paragraph 8(a), in conjunction with Article 35 of the 1951 Convention relating to the Status of Refugees, Article II of its 1967 Protocol, Article VIII(1) of the 1969 OAU Convention Governing the Specific Aspects of Refugee Problems in Africa, and Commitment II(e) of the 1984 Cartagena Declaration on Refugees.
These Guidelines clarify paragraph 164 of the UNHCR Handbook on Procedures and Criteria for Determining Refugee Status under the 1951 Convention and otherwise complement the Handbook. They are to be read in conjunction with UNHCR’s other Guidelines on International Protection.
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Towards gender - transformative HIV and TB responses
This new edition and fully updated publication replaces the 2012 UCG and is being circulated free of charge to all public and private sector prescribers, pharmacists, and regulatory authorities in the country
Following review of the latest evidence, WHO recommends that TB-LAMP can be used as a replacement for microscopy for the diagnosis of pulmonary TB in adults with signs and symptoms of TB. It can also be considered as a follow-on test to microscopy in adults with signs and symptoms of pulmonary TB, e...specially when further testing of sputum smear-negative specimens is necessary.
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There is an urgent need for safer, simpler, more efficacious and accessible treatment regimens for all forms of TB. The development of Target Product Profiles for TB treatment regimens (referred to as Target Regimen Profiles or TRPs) seeks to guide the drug development process towards important regi...men characteristics corresponding to the needs of end-users.
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The most frequent health problems of newly arrived refugees and migrants include accidental injuries, hypothermia, burns, gastrointestinal illnesses, cardiovascular events, pregnancy- and delivery-related complications, diabetes and hypertension. Female refugees and migrants frequently face specific... challenges, particularly in maternal, newborn and child health, sexual and reproductive health, and violence. The exposure of refugees and migrants to the risks associated with population movements – psychosocial disorders, reproductive health problems, higher newborn mortality, drug abuse, nutrition disorders, alcoholism and exposure to violence – increase their vulnerability to noncommunicable diseases (NCDs)
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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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Objective: To review research on associations of trauma type with PTSD in the WHO World Mental Health (WMH) surveys, a series of epidemiological surveys that obtained representative data on trauma-specific PTSD.
Research Article
PLOS ONE | DOI:10.1371/journal.pone.0164619 October 13, 2016
The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to stre...ngthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
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Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusdedit K. Mubangizi
Group Lead, Inspections, WHO-PQT E-mail: mubangizid@who.int
Acknowledgements:
• Matthias Stahl
• Milan Smid
• Antony Fake
...• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
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In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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Food environments are usually defined as the settings with all the different types of
food made available and accessible to people as they go about their daily lives.
That is, the range of food in supermarkets, small retail outlets, wet markets, street
food stalls, coffee shops, tea houses, s...chool canteens, restaurants, and all the other
venues where people buy and eat food. These environments differ enormously depending on the context. They can be extensive and diverse, with a seemingly endless array of options and price ranges, or they can be sparse, with very few options on offer. Because they determine what food consumers can access at a given moment in time, at what price, and with what degree of convenience, food environments both constrain and prompt the consumer’s choice.Food environments are influenced by the food systems which supply them, and vice versa. Food systems encompass the entire range of activities, people and institutions involved in the production, processing,
marketing, consumption and disposal of food (FAO, 2013). They include but are not limited to food supply chains. Making food systems nutrition-sensitive can contribute to addressing all forms of malnutrition, as food systems determine whether the food needed for good nutrition are available, affordable, acceptable and of adequate
quantity and quality. How closely food systems and food environments are interrelated and interdependent, and the degree to which external factors affect nutrition outcomes, varies from setting to setting.Many of today’s food systems
and food environments are challenged in supporting consumer choices that are
consistent with healthy diets and good nutrition. Consumers are not making choices based on nutrition and health, and poor diet is now the number one risk factor for death and disability worldwide (GBD, 2015). Food systems that do not enable healthy diets are increasingly recognized as an underlying cause of malnutrition (GLOPAN, 2016), and malnutrition, irrespective of form, has a huge cost. Economic costs associated with undernutrition are estimated at $1-2 trillion per year, about 2-3% of global GDP (FAO, 2013); the global economic cost of obesity and associated diet-related non-communicable diseases is estimated at $2 trillion per year, about 2.8% of global GDP (McKinsey, 2014). Influencing food environments for promoting healthy diets is an emerging strategy to address today’s nutrition challenges.
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The Scientific Conceptual Framework for Land Degradation Neutrality (LDN) provides a scientific foundation for understanding, implementing and monitoring LDN. It has been designed to create a bridge between the vision and the practical implementation of LDN, by defining LDN in operational terms. The... conceptual framework is a product of the UNCCD Science-Policy Interface.
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