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 document contains: The systematic reviews and GRADE assessments used at the Index-TB Guideline Panel in July 2015; The Evidence to Decision tables that record the Panel’s assessment and recommendations from
this meeting
Guidelines for Good Clinical Laboratory Practices (GCLP) outlines the principles and procedures to be followed by medical laboratories involved in clinical research and/or patient care so as to provide quality data which can be used for health research and patient treatment. As the use of laboratory... tests (often expensive) are increasingly becoming a part of medical diagnosis and research, generation of quality data would be a cost-effective and ethically sound strategy.
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Epidemiology
Chagas disease (American trypanosomiasis) is caused by the protozoan parasite Trypanosoma cruzi, and transmitted to humans by infected triatomine bugs, and less commonly by transfusion, organ transplant, from mother to infant, and in rare instances, by ingestion of contaminated food or... drink.1-4 The hematophagous triatomine vectors defecate during or immediately after feeding on a person. The parasite is present in large numbers in the feces of infected bugs, and enters the human body through the bite wound, or through the intact conjunctiva or other mucous membrane.
Vector-borne transmission occurs only in the Americas, where an estimated 8 to 10 million people have Chagas disease.5 Historically, transmission occurred largely in rural areas in Latin America, where houses built of mud brick are vulnerable to colonization by the triatomine vectors.4 In such areas, Chagas disease usually is acquired in childhood. In the last several decades, successful vector control programs have substantially decreased transmission rates in much of Latin America, and large-scale migration has brought infected individuals to cities both within and outside of Latin America.
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UNAIDS/10.03E / JC1767E (English original, March 2010) ISBN 978 92 9 173849 6
Provide guidance to HIV care practitioners on the optimal use of antiretroviral (ARV) agents for the treatment of HIV infection in adults and adolescents.
Male circumcision reduces a man’s risk of heterosexual acquisition of HIV by about 60%. This guideline provides an evidence-based recommendation on the use of adult male circumcision devices for HIV prevention in public health programmes in high HIV prevalence, resource-limited settings. It also p...resents key programmatic considerations for the introduction and use of these devices in public health HIV prevention programmes. The primary audiences are policy- and decision-makers, programme managers, health-care providers, donors and implementing agencies.
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The purpose of this Operational Guideline is to support state health authorities, programme managers and health care professionals with recommendations on appropriate management of children with SAM in the health facilities. Facility based management includes setting up and managing within the healt...h facility premises, a functional space where these children are cared for. This Facility Based Unit is referred to as Nutritional Rehabilitation Centre or NRC in the document. While the scale and design may vary in a given situation, it is intended that the document provide the basis for a consistent set of principles that can be used by all states for facility based management of children with SAM. The Operational Guideline focuses on the Facility/Hospital based approach for the management of SAM children under 5 years of age based on the WHO and revised IAP protocols.
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Bull World Health Organ 2017;95:594–598