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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Technical Report
AIDS Medicines and diagnostics service
September 2016
Policy Brief
HIV testing services
December 2016
WHO/HIV/2016.21
The WHO/IWA document A practical guide to auditing water safety plans provides guidance on developing and implementing a WSP auditing scheme, covering such topics as the aim and role of auditing, auditor training and certification, audit criteria, audit timing and frequency and audit reportin...g. The guidance document includes examples, tips, tools and case studies from more than a dozen low-, middle-, and high-income countries, and it serves as a practical resource for policy makers, government bodies responsible for drinking-water regulation or surveillance and water suppliers implementing WSPs.
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The purpose of this handbook is to provide guidance to Member States on the practical aspects of maintaining sanitary standards at international borders at ports, airports, and ground crossings (points of entry) as set out in the International Health Regulations (2005). It provides technical advice ...for developing a comprehensive programme for systematic monitoring of disease vectors and integrated vector control at points of entry. This includes standardizing procedures at points of entry and ensuring a sufficient monitoring and response capacity with the necessary infrastructure for surveillance and control of vectors. In addition, this handbook to serves as reference material for port health officers, regulators, port operators, and other competent authorities in charge of implementing the IHR (2005) at points of entry and on conveyances.
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External quality assessment (EQA) is an important component of quality systems for blood transfusion services. Establishing external quality assessment programmes for screening of donated blood for transfusion-transmissible infections (TTI): implementation guide aims to support WHO member States in ...establishing and operating EQA programmes for screening donated blood for TTI. The guides has been designed for use by national health authorities and EQA organizing institutions in the development of EQA programme. It will also give participating laboratories an insight into the organization of EQA programmes for TTI screening and an understanding of the benefits of participation.
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Birth defect has been an emerging major cause of child mortality in the region. Scarcity of the birth defects information hampers policy decisions and control measures at national level. In order to create evidence for action for birth defects prevention in the region, WHO-SEARO in collaboration wit...h CDC, USA has developed and launched a regional electronic database on birth defects. This surveillance database allows data collection on newborn health, birth defects and stillbirths cases and provides real time information at hospitals and national level.
Training of the hospital health staffs and data managers in the birth defects surveillance network; at regional, national and at hospital levels is recognized as essential for expansion of this database and to assure quality of data. A two days training module for hospital based birth defects surveillance was developed using a guide for operation and facilitator guide.
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Zika virus is primarily transmitted by the Aedes species of mosquito which is also responsible for the spread of dengue, Chikungunya and yellow fever viruses. In most areas, the primary vector of these viruses is Aedes aegypti, with Aedes albopictus a proven or potential vector in some settings. Wel...l-implemented vector control against Aedes using existing tools effectively reduces the transmission of viruses spread by these vectors. Pilot studies are being undertaken on new tools which have potential for future reductions in Aedes populations
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This document is written for medical doctors, clinical officers, medical assistants, nurses, midwives, health surveillance assistants (HSAs), and medical records clerks who are working in public and private sector health facilities in Malawi. It is designed to be a practical guide for implementation... of integrated HIV services.
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This is a resource pack for a Knowledge, Attitudes and Practices (KAP) surveys about Zika virus and its suspected complications such as microcephaly and Guillain-Barré syndrome.
This resource and associated advice was requested by governments and response partners as a way to rapidly obtain valuab...le and insightful information in order to tailor interventions to better address people's needs at community level, thereby contributing to the overall public health response to Zika virus and its potential complications. It can be used in communities with Zika virus transmission or those at risk.
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The WHO Regional Office for Europe has established the Childhood Obesity Surveillance Initiative in more than half thecountries in the Region for routine monitoring of the policy response to the emerging obesity epidemic. The aim of the system is to measure trends in overweight and obesity in childr...en aged 6.0–9.9 years for accurate understanding of the epidemic and to allow inter-country comparisons. This document outlines the data collection procedures agreed for use in the Initiative.
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Guidelines
UNAIDS/WHO working group on global HIV/AIDS and STI surveillance
August 2015
HIV strategic information for impact
Technical Report
AIDS Medicines and diagnostics service
July 2015
The report presents current information (updated to September 2015) on candidate vaccines, therapies and medical devices for Ebola and gives an overview of completed and on-going trials.
Methodological field approaches for scientists with a basic background in entomology to prepare and implement a yellow fever entomological assessment during outbreaks