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 publication is an updated version of the Management of Tuberculosis and HIV Coinfection clinical protocol released in 2007 by the WHO Regional Office for Europe. It is intended for all health care workers involved in preventing, diagnosing, treating and caring for people living with TB and HIV ...in the specific settings of the WHO European Region.
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This book was a project developed by the Inter-Agency Standing Committee Reference Group on Mental Health and Psychosocial Support in Emergency Settings (IASC MHPSS RG). The project was supported by global, regional and country based experts from Member Agencies of the IASC MHPSS RG, in addition to ...parents, caregivers, teachers and children in 104 countries.
The book was shared through storytelling to children in several countries affected by COVID-19. Feedback from children, parents and caregivers was then used to review and update the story.
Over 1,700 children, parents, caregivers and teachers from around the world took the time to shared how they were coping with the COVID-19 pandemic. Available in 141 Languages
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The GNC is managing COVID-19 webpage with global, regional, and country-level resources for COVID-19 to assist Nutrition in Emergencies (NiE) practitioners and coordination teams with integration of COVID-19 preparedness and response into humanitarian nutrition response. In addition to the documents... that were developed by the GNC and Global Technical Assistance Mechanism for Nutrition (GTAM), it also includes other resources developed at global, regional and country levels that were neither developed nor endorsed by the GNC. Given the rapidly evolving situation, the webpage is continuously updated
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WHO’s Global Health Estimates (GHE) provide the latest available data on death and disability globally, by region and country, and by age, sex and cause. The latest updates include global, regional and country trends from 2000 to 2019 inclusive. By providing key insights on mortality and morbidity... trends, these estimates are a powerful tool to support informed decision-making on health policy and resource allocation.
The next update to these estimates will include an assessment of the direct and indirect impact of the COVID-19 pandemic on mortality and morbidity.
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It will be updated continuously.
Details of COVID-19 availability in all ten ASEAN countries and another 30 Asian nations.
Due to the developing situation in China and Asia concerning the Coronavirus, we will be operating this article as a running live update service to keep businesses involved in... ASEAN and Asia updated with the latest relevant regional news.
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Based on the recently updated 2018 WHO-WFSA International Standards for a Safe Practice of Anaesthesia the WFSA has developed the Anaesthesia Facility Assessment Tool (AFAT) in order to help regional and national anaesthesia and health care leadership to gather data about anaesthesia workforce, equi...pment, medicines and practice at the facility level.
The AFAT is part of a shared effort to improve data collection and knowledge management in support of the implementation of World Health Assembly Resolution 68.15 and to ensure that anaesthesia is represented in national health planning and in National Surgical, Obstetric & Anaesthesia Plans (NSOAPs).
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Europe and Central Asia Economic Update.
The Russian Federation’s war with Ukraine has triggered a catastrophic humanitarian crisis and threatened the stability of geopolitical relations. Economic output in the Europe and Central Asia region is forecast to contract by more than 4.1% in 2022—the... second major shock and regional recession in two years. Moreover, the war has added to mounting concerns of a sharp global growth slowdown.
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The Strategic Advisory Group of Experts (SAGE) on Immunization held a meeting on 3-6 October 2022. This report summarizes the discussions, conclusions and recommendations.
It covers the following items:
Global Reports
Immunization Agenda 2030 and Regional reports
Monkeypox
RSV
COVID-19 vacci...nes
Polio vaccination
Ebola (Sudan ebolavirus outbreak update)
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NFPA continues to work with partners to respond to the Ukraine emergency. Highlights from the month of January include:
- The #TrainOfHope launched between Kyiv and Chisinau is a lifeline, providing refugees, including many women with children, both a route to safety and a way back home.
- When t...he Government of Ukraine lost control of Kherson city, social workers at a shelter for survivors of domestic violence continued to work so that women and girls could receive essential assistance.
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Snake-bites are well-known medical emergencies in many parts of the world, especially in rural areas. Agricultural workers and children are the most affected. The incidence of snake-bite mortality is particularly high in South-East Asia. Rational use of snake anti-venom can substantially reduce mort...ality and morbidity due to snake bites. These Guidelines are a revised and updated version of similar guidelines published by the WHO Regional Office in South-East Asia in 1999. These guidelines aim to promote the rational management of snake-bite cases in various health facilities where trained health functionaries and quality snake antivenom are available.
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Website last accessed on 07.06.2023
Stopleishmania.org is an initiative of the VISAVET Health Surveillance Centre (UCM), the National Centre of Microbiology (ISCIII), the Animal Protection Centre (Madrid City Council) and the Directorate of Public Health (Regional Government of Madrid). This proj...ect launches the possibility of collaboration with other research centres, feeding the site with updated information on this disease.
Leishmaniosis prevention and control should include novel communication strategies that must be easily accesible and would include new advances in the knowledge of the disease. Recently, other animals different than dogs have been described as competent reservoirs of Leishmania, playing an important epidemiological role in recent outbreaks in Europe and Asia. At the moment, most of the information available is fundamentally devoted to humans and dogs, and there is no a global approach to the disease, taking into account all possible reservoirs.
The contents are available in Spanish and English, and come from the knowledge and experience in the disease of the above mentioned organisms, including research and information outreach.
The result is a website mainly focused on dissemination of the fundamental aspects for the control and prevention of the disease, taking into account that leishmaniosis due to its zoonotic condition, requires a multidisciplinary vision in accordance with the "One Health" principles. The web is complemented by a collaborative tool where the registered research groups can present themselves and disseminate their research results, therefore providing updated information on the scientific advances in the disease control.
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Regional Cholera Bulletin
The key actions, activities, and approaches in this document are organized within each of the 5Cs (see Table 1 in the PDF) and those of the Strategic preparedness and response plan (SPRP) pillars as follows:
National action plan key activities, prioritized for the current context and the current ...understanding of the threat of SARS-CoV-2
A. Transition from emergency response to longer term COVID-19 disease management.
B. Integrate activities into routine systems.
C. Strengthen global health security.
Special considerations for fragile, conflict-affected and vulnerable (including humanitarian) settings
WHO global and regional support to Member States to implement their national action plans
Key guidance documents for reference
This is a living document that will be updated to incorporate new technical guidance in response to the evolving epidemiological situation. National plans should be implemented in accordance with the principles of inclusiveness, respect for human rights, and equity.
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Building on the 2021 Interim guidance, this second version and update, incorporates the lessons and feedback from the hepatitis pilots that successfully demonstrated the feasibility of measuring hepatitis B and C impact targets to demonstrate elimination, whilst highlighting challenges caused by hig...h disease burden in some countries, as well as delays in reaching mortality targets due to the long natural history of disease progression to liver cirrhosis and hepatocellular carcinoma.
The path to elimination provides a framework with 3 levels of achievements for which WHO certification is available. Each stepwise progression from bronze to silver to gold tiers will promote an iterative expansion of prevention, diagnosis and treatment services for viral hepatitis services and strengthen measurement systems to support attainment of the 2030 elimination goals.
This updated version also includes changes, clarifications and new guidance on alternative measurement approaches for country validation of elimination. Through the validation process, WHO and partners continue to provide country support for strengthening health system capacity and patient-centred services that respect and protect the human rights of people living with viral hepatitis and ensures meaningful engagement of communities in the national, regional and global viral hepatitis response.
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Vaccines are powerful weapons in the fight against pandemic viruses as shown by responses to both the 2009 H1N1 influenza and the COVID-19 pandemics. However, planning for accessing, allocating and deploying vaccines in a pandemic situation is a complex endeavour, beset with multiple challenges at a...ll levels – local, regional and global. The World Health Organization (WHO) and its partners have prepared this revised guidance document to assist countries update their national deployment and vaccination plans (NDVPs) by leveraging global learnings from past pandemic responses, including the recent COVID-19 vaccination effort. The development and testing of a NDVP would not only advance pandemic preparedness efforts but would also have benefits in terms of increasing national capabilities to manage other health emergencies which require emergency vaccination campaigns.
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The 2030 Agenda for Sustainable Development includes a vision of healthy lives and well-being for all at all ages. This major report provides an update on progress towards the health-related Sustainable Development Goals (SDGs) in the WHO Eastern Mediterranean Region. It presents regional tren...ds between 2010 and 2022 for 50 health-related SDG indicators using available data from WHO and estimates from other United Nations agencies. The report reveals some successes at the country level amid a marked slowdown regionally with setbacks across indicators on health health risks and determinants and access to services. We are at the halfway point for the 2030 Agenda for Sustainable Development: to reverse current trends and ensure the health and well-being of our population we must take bold steps now.
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