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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Development assistance for health (DAH)
plays a vital role in supporting health programmes in lowand middle-income countries. While DAH has historically
focused on infectious diseases and maternal and child
health, there is a lack of comprehensive analysis of DAH
trends, strategic shifts and the...ir impact on health systems
and outcomes. This study aims to provide a comprehensive
review of DAH from 1990 to 2022, examining its evolution
and funding allocation shifts.
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USAID Office of HIV/AIDS
March 8-9, 2016
n the countries of the Region of the Americas, there are different forms of organization of health services at the first level of care. Some countries include certain laboratory, dental and diagnostic imaging practices in the first level of care, while other countries centralize these practices in t...he second and third levels of care. Consequently, so that the List of Priority Medical Devices (LPMD) could be adapted to these different forms of organization of health systems in the region of the Americas, modular lists were developed that complement the main list. In this way, to use the LPMD, only those modules that are planned to be offered in a first-level care center are selected, and it is those lists that are analyzed.
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The Africa Centres for Disease Control and Prevention (Africa CDC) Biosafety and Biosecurity Initiative was launched by the Africa CDC in April 2019 with the aim of strengthening the African Union (AU) Member States’ biosafety and biosecurity systems and enabling them to comply with national and i...nternational requirements for biosafety and biosecurity including the International Health Regulations (IHR) (2005), the Biological Weapons Convention (BWC), and United Nations Security Council Resolution (UNSCR) 1540 and the multi-country Global Health Security Agenda (GHSA). The World Health Organization (WHO) Joint External Evaluation (JEE) and the Global Health Security Index report confirmed the known capacity gaps in biosafety and biosecurity among Africa Union Member (AU).
The regional consultations by Africa CDC conducted between 2019-2021 highlighted the deficiency or limited availability of standardized and regionally recognized training programs in the continent, limiting biosafety and biosecurity capacity building efforts in the region. In response, Africa CDC working with AU Member States developed a home grown, implementable and accessible professional training and certification program that is both recognized and endorsed by AU Member States. The Regional Training and Certification Program for Biosafety and Biosecurity Professionals, for African Biosafety and Biosecurity Professionals (RTCP-BBP) has four (4) areas of specialization, namely
Selection, Installation, Maintenance and Certification of Biological Safety Cabinets
Biorisk Management
Design and Maintenance of Facilities Handling High Risk Pathogens (Biocontainment Engineering)
Biological Waste management
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Policy Brief
published: 16 March 2018 doi: 10.3389/fpubh.2018.00069
: Development assistance for health (DAH) is one of the most important means for Japan to promote
diplomacy with developing countries and contribute to the international community. This study, for the first time,
estimated the gross disbursement of Japan’s DAH from 2012 to 2016 and clarified its... flows, including source, aid
type, channel, target region, and target health focus area
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WHO recommends prompt recognition of progressive acute hypoxaemic respiratory failure when a patient with respiratory distress is failing to respond to standard oxygen therapy and adequate preparation to provide advanced oxygen/ventilatory support.
Hypoxaemic respiratory failure in ARDS commonly re...sults from intrapulmonary ventilation-perfusion mismatch or shunt and usually requires mechanical ventilation.
At any time, if there are urgent or emergent indications for intubation, do not delay.
WHO suggests that hospitalized patients with severe or critical COVID-19 with acute hypoxaemic respiratory failure that do not require emergent intubation be treated with HFNO, or CPAP or NIV (BiPAP) rather than standard oxygen therapy.
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Médecins sans Frontières access campaign
Issue Brief
Accessed: 28.11.2019
For patients on HFNO with persistent hypoxaemia or respiratory distress:
• Check the equipment: inspect the exterior of the machine, the tubing (circuit), the prong for any sign of mechanical damage, confirm it fits and the filters are in place. Ensure the settings are appropriate and flow is max...imized.
• Check the oxygen source: there is sufficient oxygen available and flowing through the device. If FiO2 > 50% of oxygen is needed, the device must have a blender.
• Check there is no obstruction with secretions: patients with COVID-19 may have very thick secretions which may block small and large airways and cause sudden respiratory deterioration.
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The goal of the study was to assess the feasibility of the COVID-19 measures and their resultant impact on Persons with Disabilities in Malawi.
Specifically, the study addressed the following objectives:
a) To evaluate Government’s response to COVID-19 following the adoption of the new measures... of COVID-19 in January 2021 in line with principles and norms of human rights. (This includes establishing the extent to which the new measures have been implemented)
b) To assess the extent to which the provision health service delivery specifically access to health for PWDs including vaccine inflammation and facilities.
c) To establish the key COVID-19 related human rights violations during the pandemic period affecting PWDs
d) To assess the extent to which Government (and other nonstate actors) have implemented the recommendations from the preliminary MHRC statement
e) To provide advice and make recommendations to the Executive, Parliament and other stakeholders on how they can improve their response to COVID-19 from a rights perspective with a focus on PWDs.
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Este documento complementa los contenidos del Seminario de formación y supervisión técnica en valoración de sospechas de ASI realizado durante los meses de febrero a mayo de 2007
For patients on NIPPV or HFNO with persistent hypoxaemia or respiratory distress:
• Check the equipment: inspect the exterior of the machine, the tubing (circuit), the mask for any sign of mechanical damage, confirm it fits securely without leak (if CPAP/BiPAP) and the filters are in place. Ensur...e the settings are appropriate and flow is maximized.
• Check the oxygen source: there is sufficient oxygen available and flowing through the device. If FiO2 > 50% of oxygen is needed, the ventilator must have a blender.
• Check there is no obstruction with secretions: patients with COVID-19 may have very thick secretions which may block small and large airways and cause sudden respiratory deterioration.
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DHS Working Papers No. 101
Women’s empowerment, HIV testing, birth in past five years, Tanzania