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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This manual is addressed to health care providers dealing with Mycobacterium ulcerans disease (Buruli ulcer). The manual aims to achieve a better understanding of the disease, its clinical presentation and its surgical management. The manual is aimed particularly at district health care providers. A... comprehensive protocol, adapted to each form and stage of the disease, is presented together with comments on the levels of resources and capabilities necessary
to shorten the length of treatment, to prevent complications and to minimize undesired sequelae and thus to obtain the best possible outcome for each patient. Some sections include advice relevant to surgeons (e.g. relating to bone infection). However, the level to which particular comments are intended to apply should be clear from the context.
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Palliative care for children with life-limiting illness is the active total care of the child’s body, mind, and spirit. It begins at diagnosis and continues regardless of whether the child receives treatment directed at the disease. It seeks to control all forms of suffering related to the illness..., including pain. It involves social, psychological, spiritual, and legal support to siblings, parents, and other close family members. Effective palliative care for children requires health professionals trained to assess symptoms, care for children of different ages and developmental stages, and to provide medicines in pediatric formulations. Care may be provided in tertiary care facilities, community health centers, and at home. The child’s best interest must inform all aspects of the treatment andcare, and the child’s rights must be protected at all times.
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In this document, the Inter-American Committee of Cardiovascular Prevention and Rehabilitation, together with the South
American Society of Cardiology, aimed to formulate strategies, measures, and actions for cardiovascular disease prevention
and rehabilitation (CVDPR). In the context of the imple...mentation of a regional and national health policy in Latin American
countries, the goal is to promote cardiovascular health and thereby decrease morbidity and mortality. The study group on
Cardiopulmonary and Metabolic Rehabilitation from the Department of Exercise, Ergometry, and Cardiovascular Rehabilitation
of the Brazilian Society of Cardiology has created a committee of experts to review the Portuguese version of the guideline
and adapt it to the national reality.
The mission of this document is to help health professionals to adopt effective measures of CVDPR in the routine
clinical practice. The publication of this document and its broad implementation will contribute to the goal of the World
Health Organization (WHO), which is the reduction of worldwide cardiovascular mortality by 25% until 2025.
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INT J TUBERC LUNG DIS 22(2):197–205 http://dx.doi.org/10.5588/ijtld.17.0245
The focus of the current quarterly edition of Eurohealth (from the European Observatory on Health Systems and Policies) is Antimicrobial Resistance (AMR) and contains the following articles:
• Strengthening implementation of AMR national action plans
• Fostering clinical developmen...t and commercialisation of novel antibiotics
• Tackling AMR in the community
• Quantifying the benefits of vaccines in combating AMR
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Evidence shows that oral pre-exposure prophylaxis (PrEP) reduces the risk of contracting HIV during sexual intercourse by more than 90% when taken daily. It is for this reason the National HIV Prevention Strategy 2015-2020 (2018 Revision) emphasises the role of preexposure prophylaxis (PrEP) in ...reducing new HIV infections in Malawi.
The Ministry of Health has prioritised PrEP use among the populations most at-risk of HIV infection in Malawi: young women ages 10 to 24 years, sero-discordant couples, female sex workers, men who have sex with men, and other priority populations (such as members of the uniformed services, prisoners, and mobile populations).
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International Journal of Infectious Diseases 70 (2018) 121–130
https://doi.org/10.1016/j.ijid.2018.03.007
1201-9712/© 2018 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http://cr...eativecommons.org/licenses/by-nc-nd/4.0/).
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Eur Respir J 2016; 48: 808–817 | DOI: 10.1183/13993003.00840-2016
PLoS Neglected Tropical Diseases https://doi.org/10.1371/journal.pntd.0004762
This study shows the importance of an integrated entomological and medical surveillance for the evaluation of arboviral disease risk, which is a precondition for designing cost-effective vector control programs.
The present Community Empowerment Manual draws upon the lessons learned of the Community Protection Approach implementation in Lebanon, the occupied Palestinian territory and Central America during the period 2015-2020 by WeWorld – GVC and its partners.
The Manual means to accompany Field Staff i...n devising the most appropriate strategy to engage with communities, given the conditions of access, security and time of the specific context in which a project is implemented. Even though the steps described proceed alongside the implementation of the Community Protection Approach, the manual has different sections providing guidance for the definition of engagement strategies in any context or project in question.
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WHO published guidance for clinicians and health care decision-makers on the use of corticosteroids in patients with COVID-19.
We recommend systemic corticosteroids for the treatment of patients with severe and critical COVID-19. We suggest not to use corticosteroids in the treatment of patients ...with non-severe COVID-19 as the treatment brought no benefits, and could even prove harmful. Treatment should be under supervision of a clinician.
Corticosteroids are listed in the WHO model list of essential medicines, readily available globally at a low cost. WHO encourages countries to maintain sufficient stocks of corticosteroids to treat COVID-19 and the other disease for which they are effective, while not maintaining excessive stocks which could deny other countries access.
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This document provides interim guidance on the prevention, identification and management of health worker infection in the context of COVID-19. It is intended for occupational health departments, infection prevention and control departments or focal points, health facility administrators and public ...health authorities at both the national and facility level.
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В сборнике представлены статьи специалистов в сфере охраны психического здоровья по различным академическим дисциплинам, включая общую медицину, психиатрию, пси...отерапию, психологию, социологию, педагогику, юриспруденцию, экономику, спорт, по материалам Конгресса ≪Психическое здоровье человека XXI века≫, который состоялся 7–8 октября 2016 г. в Москве.
The collection of scientific papers is collected from different areas of scientific knowledge, including general medicine, psychiatry, psychotherapy, psychology, social policy, education, law, economics and sport. The publication contains materials that were delivered to the Organizing Committee of the Congress on Mental Health: Meeting the Needs of the XXI Century. The collection is intended for researchers and practitioners acting in the field of the mental health care.
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CẨM NANG AN TOÀN SINH HỌC PHÒNG XÉT NGHIỆM LAO.
NHÀ XUẤT BẢN Y HỌC HÀ NỘI - 2015.