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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The indicators and questions in this document are designed for use by national AIDS programmes and partners to assess the state of a country’s HIV and AIDS response, and to measure progress towards achieving national HIV targets. Countries are encouraged to integrate these indicators and questions... into their ongoing monitoring efforts and to report comprehensive national data through the Global AIDS Monitoring (GAM) process. In this way they will contribute to improving understanding of the global response to the HIV epidemic, including progress that has been made towards achieving the commitments and global targets set out in the new United Nations Political Declaration on HIV and AIDS: Ending Inequalities and Getting on Track to End AIDS by 2030, adopted in June 2021, and the linked Sustainable Development Goals.
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Following an overview of maternal and neonatal child health in Nepal and in the districts covered by the project, the briefing outlines the background to the Strengthening Approaches for Maximizing Maternal, Neonatal and Reproductive Health (SAMMAN) project. It then describes the key aspects of the ...two main project approaches: one focused on the community level, and the other on health systems
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Final Report: Women in War
Antimicrobial resistance (AMR) is a global public health crisis that resulted in 1.14 million deaths in 2021. According to the Institute for Health Metrics and Evaluation estimates, 96 416 of these deaths occurred in the World Health Organization (WHO) Eastern Mediterranean Region. All 22 countr...ies/territories in the Eastern Mediterranean Region are enrolled in the global AMR
surveillance system, and 17 countries/territories reported data in 2024 (for the year 2023). The total number of isolates reported to the system increased sixfold between 2017 and 2022, but the proportion of blood isolates is relatively very low. Most of the data come from public sector laboratories or hospitals, although the private sector has increased its participation in some countries/territories recently. Three pathogens account for three quarters of all the reported pathogens – Escherichia coli
(26%), Klebsiella pneumoniae (23%), and Staphylococcus aureus (22%).
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he National Department of Health (NDOH) presents this Malaria Elimination Strategic
Plan 2019-2023 for the Republic of South Africa. The strategy comes at an important time
as the Southern African Development Community (SADC) heads of state have recently
renewed the commitment to eliminate malari...a in Botswana, Eswatini, Namibia and South
Africa by 2020 and in the whole SADC region by 2030, with the target of zero local malaria
cases and deaths. South Africa has made steady progress towards this elimination goal
through the implementation of evidence-based malaria policies aligned to the World Health
Organization’s (WHO) Global Technical Strategy.
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The Epidemic Preparedness and Response Plan for Cholera in Syria (November 2015) outlines strategies to prevent, detect, and manage cholera outbreaks in the country, where poor water and sanitation conditions, displacement, and damaged healthcare infrastructure increase the risk of disease spread. T...he plan aims to reduce morbidity and mortality through early detection, rapid response, and coordinated interventions. It is divided into four key phases: the Pre-Epidemic Phase, which includes risk assessment, resource mapping, stockpiling medical supplies, training health workers, and raising community awareness; the Alert Phase, which focuses on surveillance, laboratory confirmation, and mobilization of rapid response teams; the Epidemic Phase, which involves case management, infection control, environmental measures such as water chlorination and improved sanitation, and public awareness campaigns; and the Post-Epidemic Phase, which evaluates the response effectiveness and identifies lessons to improve future preparedness. The plan emphasizes multi-sectoral coordination, strengthening health surveillance, and ensuring timely intervention to control and prevent cholera outbreaks in vulnerable communities.
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Project Paper to provide an additional grant for: Human Development Systems Strengthening Project (HDSSP)(P145965, H9360)
The training courses cover a wide range of technical and disease topics, to help prepare response workers with the skills and knowledge they need in a health emergency.