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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March 2021
This report presents the key findings of the NFHS-5 survey in Sikkim, followed by detailed tables and an appendix on sampling errors. The 2019-21 National Family Health Survey (NFHS-5), the fifth in the NFHS series, provides information on population, health, and nutrition for India and ...each state and union territory.
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Infection prevention and control (IPC) in a CTC/ CTU IPC are all practical measures taken in the healthcare facility to prevent harm caused by infections to patients, health workers and communities.
The main goal of IPC in the cholera response is to
• To reduce transmission of health care-as...sociated infections of cholera and any other infectious disease
• To enhance the safety of staff, patients and visitors
• To enhance the ability of the organization/health care facility to respond to an outbreak
• To reduce the risk of the hospital (health care facility) itself amplifying the outbreak
Water, Sanitation and Hygiene (WASH)
WASH are all measures taken to guarantee environmental hygiene, safe water of all used within the health facility. It encompasses water, sanitation, waste management, cleaning within the health facility which in this case is CTU/C. A complete WASH package in the CTU/CTC reduces the risk of spread of Vibrio cholerae inside and outside the CTC/CTU.
The probability of spreading or acquiring cholera through a CTC/CTU can be highly reduced when proper IPC and WASH measures are respected, followed and monitored. These measures are, in principle, valid in CTC/CTUs and ORPs, although they need to be adapted to the specific characteristics of the facility concerned.
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March 2021
This report presents the key findings of the NFHS-5 survey in Tripura, followed by detailed tables and an appendix on sampling errors. The 2019-21 National Family Health Survey (NFHS-5), the fifth in the NFHS series, provides information on population, health, and nutrition for India and... each state and union territory.
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May 2021
This report presents the key findings of the NFHS-5 survey in Telangana, followed by detailed tables and an appendix on sampling errors. The 2019-21 National Family Health Survey (NFHS-5), the fifth in the NFHS series, provides information on population, health, and nutrition for India and... each state and union territory.
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July 2021
This report presents the key findings of the NFHS-5 survey in Meghalaya, followed by detailed tables and an appendix on sampling errors. The 2019-21 National Family Health Survey (NFHS-5), the fifth in the NFHS series, provides information on population, health, and nutrition for India an...d each state and union territory.
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Malawi is a landlocked country with a surface area of 118,484 km2. Administratively, the country is divided into three regions, namely the Northern, Central and Southern regions. The country has 28 districts, which are further divided into traditional authorities (TA) ruled by chiefs. The TAs are su...b-divided into villages, which form the smallest administrative units. The Village Development Committees (VDCs) under the TAs are responsible for development activities. Politically, each district is divided into constituencies that are represented by Members of Parliament (MPs) in the National Assembly for purposes of legislations. Constituencies are further divided into wards which are represented by a ward councillor at district assembly.
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The aim of the Annual Inspection Report is to present findings of public sector health establishments inspected by the OHSC to monitor compliance with the National Core Standards (NCS) during the 2016/2017 financial year in South Africa.
The NCS define fundamentals for quality of care based on six ...dimensions of quality: Acceptability,Safety, Reliability, Equity, Accessibility, and Efficiency.
The NCS structured assessment tools were used to collect data during inspections across the seven domains namely: Patient Rights; Patient Safety, Clinical Governance and Clinical Care; Clinical Support Services; Public Health; Leadership and Governance; Operational Management and Facilities and Infrastructure. A total of 851 routine inspections were conducted with 201 of these facilities re-inspected. Inspection data was captured on District Health Information System (DHIS) data entry forms and exported for analysis to Statistical Analysis Software (SAS) version 9.4.
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Die Handreichung zeigt, wie die von den Vereinten Nationen in 2015 verabschiedete Agenda 2030 mit ihren 17 globalen Zielen für nachhaltige Entwicklung (Sustainable Development Goals, SDGs) in den schulischen Unterricht integriert werden kann und leistet zugleich einen Beitrag zur Realisierung der ...in den 17 SDGs festgeschriebenen Zielsetzungen.
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This study, and similar studies in Kenya, Mozambique, Swaziland, Uganda, and Zambia is the outcome of close collaborative by a team in Swaziland, with technical and financial support from the UNAIDS Regional Support Team for Eastern and Southern Africa, UNAIDS Geneva, and the World Bank's Global HIV.../AIDS Program (Global AIDS Monitoring and Evaluation Team). The study entailed using existing data and collecting new data to better know the country's HIV epidemic, know the country HIV response and how funding was allocated, so as to improve the HIV response and strengthen prevention based on evidence on what works to prevent new infections.
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Countries around the world are facing the challenge of increased demand for care of people with COVID-19, compounded by fear, misinformation and limitations on movement that disrupt the delivery of health care for all conditions. Maintaining essential health services: operational guidance for the CO...VID-19 context recommends practical actions that countries can take at national, subregional and local levels to reorganize and safely maintain access to high-quality, essential health services in the pandemic context. It also outlines sample indicators for monitoring essential health services, and describes considerations on when to stop and restart services as COVID-19 transmission recedes and surges.
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This document describes the ethical values that are most important to the nursing profession in Ontario. It also provides scenarios of ethical situations in which there is a conflict of values. Nurses are encouraged to use these scenarios for reflection and discussion. No solutions are offered becau...se there is no one solution that is best in all situations. The behavioural directives are intended to help nurses work through ethical situations and provide information about the College of Nurses of Ontario’s (CNO’s) expectations for ethical conduct. These are taken into account when CNO Committees assess nurses’ practices. Nurses need to consider behavioural directives carefully when making decisions about ethical care as this process will strengthen their practice.
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Guide for clinical case management and infection prevention and control during ameasles outbreak. This guide has been developed to reduce the high morbidity and mortality seen in some of the current outbreaks of measles. This short guide outlines practical clinical care interventions and is derived ...from previously published WHO documents.
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This manual presents a compelling case for action on carbapenem-resistant organisms (CROs) and describes the linkages between the prevention and control of CROs and the Global Action Plan on Antimicrobial Resistance (AMR). It describes how the eight recommendations contained within the World Health ...Organization (WHO) guidelines for the prevention and control of carbapenem-resistant Enterobacteriaceae, Acinetobacter baumannii and Pseudomonas aeruginosa in health care facilities relate to general measures (that is, the core components of infection prevention and control [IPC] programmes) that need to be in place in all countries and health care facilities to prevent and control health care-associated infections (HAIs). The use of a stepwise approach is proposed to support implementation and improvement, based on the evidence and experience of what has worked in several health care settings worldwide. The focus is on adoptable and adaptable information.
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This guide was prepared to enable advocates to use data
when advocating for universal access to SRHR at the national,
regional and global levels. It is a direct outcome of the Strategic
SRHR Indicators workshop held in Kuala Lumpur, Malaysia on
21-22 August for the project “Strengthening the N...etworking,
Knowledge Management and Advocacy Capacities of an AsiaPacific
Network for SRHR” supported by the EU.
One of the major objectives of the project is to develop
a comprehensive monitoring framework of indicators for
measuring government performance to fulfil their international
commitments, particularly to the ICPD and the MDGs, both in
the Asia-Pacific region and globally.
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Informationen zu Fragen der Prävention und Gesundheit ihrer Kinder und zu den Möglichkeiten der
Sozialen Sicherung sind für Eltern von besonderer Bedeutung. Fremdsprachige Informationsmaterialien
können die gegenseitige Verständigung und die Vermittlung von Informationen in der Beratung von... Familien mit Migrationshintergrund erleichtern. Inzwischen gibt es einige fremdsprachige Angebote, die im Kindes- und Jugendalter relevant sind. Die vorliegende Broschüre erleichtert den Zugang durch eine aktuelle Zusammenstellung dieser Qüllen.
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This paper presents lessons learned from previous flood responses in developing countries, based on a structured review of the literature. It is intended for people working in relief and recovery operations who have to decide if, when and how to intervene after a flood.
El maltrato infantil incluye la perpetración de violencia física, sexual y psicológica o emocional, y el descuido de bebés, niños, niñas y adolescentes de 0 a 17 años por parte de progenitores, cuidadores y otras figuras de autoridad, con mayor frecuencia en el hogar, pero también en entorno...s como escuelas y orfanatos. Es un problema importante de salud pública y
una violación de los derechos humanos fundamentales, incluido el derecho a la vida, el derecho a la protección contra todas las formas de violencia y el derecho al goce del grado más alto posible de salud. El maltrato infantil puede tener consecuencias negativas graves y, a menudo, de por vida para la salud mental y física, la salud sexual y reproductiva, el desempeño
académico y la vida social.
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The Democratic Republic of Timor-Leste has the highest TB incidence rate in the South East Asian Region - 498 per 100,000, which is the seventh highest in the world. In Timor-Leste TB is the eighth most common cause of death.
The salient observations are as follows:
In 2018, 487 (12.5%) of the... 3906 notified TB patients were tested for RR-TB and only 12 lab confirmed RR-TB patients were initiated on standard MDR-TB treatment of 20-months duration, (a 3-fold increase in RR-TB detection compared with 2017). This amounts to treatment coverage of only 17% of 72 estimated MDR/RR-TB among notified TB patients (3906) and 5% of 240 estimated incident MDR-TB patients as compared to 62% treatment coverage of 6300 incident drug sensitive TB patients estimated in TLS. The treatment success in the 2016 annual cohort of 6 MDR-TB patients has been reported at 83%. 80% of TB patients know their HIV Status with around 1% TB-HIV co-infection, 37/ 77 (48%) TB-HIV Co-infection Detected. Of the 387 PLHIV currently alive on ART, exact status on TB screening and testing is unknown. % of PLHIV newly enrolled in HIV care who received IPT is not known.
In 2018, the mortality rate for TB was 94 deaths per 100,000 people (1200 per annum) in TL with an increasing mortality trend (Figure 1), despite TB services being available for nearly two decades.
A survey of catastrophic costs due to TB (2016) highlights that 83% of TB patients are reported to be facing catastrophic costs due to the disease. This is the highest rate in the world.
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A medida que el tratamiento antirretrovírico con dolutegravir se extiende a más personas que viven con el VIH en el
mundo, adquiere más importancia estimar la frecuencia con que surge la farmacorresistencia adquirida a este
antirretrovírico en las poblaciones tratadas con esquemas que lo conti...enen. Si bien no se ha detectado resistencia
al dolutegravir en los ensayos clínicos con poblaciones no tratadas antes con antirretrovíricos en las que se ha
detectado una viremia persistente pese al tratamiento, los datos indican que puede surgir en quienes toman esquemas
con dolutegravir. La OMS recomienda a los países que estén ampliando el tratamiento con dolutegravir que acompañen
su despliegue con la vigilancia sistemática de la farmacorresistencia.
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