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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Educational materials (slide presentations) from FAO covering important biosecurity aspects in poultry farms
This course is designed for anyone with an interest in antibiotic resistance, no matter if you are a member of the public, a student, a health professional or any other expert.
Our focus is to provide an overview of antibiotic resistance from several different angles. An important aim is to give an... understanding of the mechanisms behind the increasing prevalence of antibiotic resistance worldwide, but also what the society and you as an individual can do to control and prevent further emergence and spread of antibiotic-resistant bacteria.
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Health Care Facilities (HCFs) are primarily responsible for management of the healthcare waste generated within the facilities, including activities undertaken by them in the community. The health care facilities, while generating the waste are responsible for segregation, collection, in-house trans...portation, pre-treatment of waste and storage of waste, before such waste is collected by Common Bio-medical Waste Treatment Facility(CBWTF) Operator. Thus, for proper management of the waste in the healthcare facilities the technical requirements of waste handling are needed to be understood and practiced by each category of the staff in accordance with the BMWM.
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This report presents operational recommendations based on monthly COVID-19 online and offline community feedback trends analysis in Africa.It aims to enable evidence-based decision-making at
regional and national levels.
This guideline aims to improve the quality of donations and the management thereof and serve as the basis for policies of the State and other organizations in the giving and receiving of donations of medicines, medical devices and IVDs.
Over the last three or four decades, there has been an enorm...ous increase in scientific knowledge about the mode of action, effects and side effects of medicines, medical devices and IVDs. It is important for all
stakeholders to understand that these products have both benefits and risks, that they have to be used carefully and appropriately and that some can do more harm than good.
There are many different scenarios for the donation of medicines, medical devices and IVDs. Donations may take place in acute emergencies or as part of development aid in non-emergency situations. They may involve donations (i.e. direct or through private voluntary organizations), aid by governments or persons authorized to sell medicines, medical devices and/or IVDs.
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The COVID-19 Vaccine (Whole Virion Inactivated) BBV152, COVAXIN® vaccine explainer includes key information on the vaccine specific requirements.
WHO/UNICEF joint statement
9 Febr. 2022
The COVID Covovax™ (SIIPL) and Nuvaxovid™ (Novavax) vaccine explainer includes key vaccine specific information on the vaccine specific requirements.
Reviewed Essential Medicines List July 2021
The results of the SHINE trial have been published in the NEJM today. SHINE looked at whether treatment for children with minimal TB could be reduced from 6 months to 4 months. It found that the four month treatment was as good as the standard six months treatment for children with minimal TB
Wearing a face mask can help reduce the spread of COVID-19 in the community by reducing the release of respiratory droplets from asymptomatic / pre-symptomatic individuals or those with mild non-specific symptoms. The use of face masks for this purpose may be adopted to reduce the societal impact as...sociated with absence from work or healthcare pressures due to infection, or to protect vulnerable individuals in particular settings.
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Project Drawdown (2022) provides evidence of how climate solutions can also be win-win opportunities for meeting development and human well-being needs while boosting prosperity for rural communities in sub-Saharan Africa and South Asia. The report summarizes the co-benefits of five groups of a subs...et of Project Drawdown climate solutions (28 total solutions) for advancing human well-being in rural areas of low- and middle-income countries
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The pharmaceutical sector of any nation is responsible for providing society with quality medicines and other pharmaceutical services. According to the World Health Organization (WHO), Pharmaceuticals may constitute as much as 40% of the national health budget in developing countries, yet portions o...f the population may lack access to the most essential medicines; while the limited funds available for health are spent on unnecessary, ineffective and even dangerous medications.
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The Global Burden of Disease (GBD) 2010 Study has published disability-adjusted life year (DALY) data
at both regional and country levels from 1990 to 2010. Concurrently, the Institute for Health Metrics and Evaluation
(IHME) has published estimates of development assistance for health (DAH) at th...e country-disease level for this
same period of time.
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