BMC Public Health (2016) 16:766
DOI 10.1186/s12889-016-3455-5
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
District hospital level Severe | Malaria is a Medical Emergency
PQDx 0006-005-00 WHO
PQDx PR
February/2016, version 2.0
PQDx 0198-071-00
WHO PQDx PR
April/2016, version 2.0
Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor quality, unsafe medicines and pharmaceutical products promote drug resistance and lead to loss of confidence in health prof...essionals, manufacturers and distributors and in health systems. In an effort to protect people’s health, the WHO Regional Director for Africa, Dr Matshidiso Moeti, has proposed a strategy aimed at strengthening National Medicine Regulatory Authorities (NMRAs) in order to ensure that only safe, good quality and effective medical products are available.
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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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