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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An Independent Report
of the West Africa Commission on Drugs
In 2016 CRS leveraged the robust infrastructure of its large, multi-sectoral orphans and vulnerable children (OVC) program in Nigeria by expanding the program's core mandate to include community childhood TB casefinding, with a focus on highly vulnerable children and their caregivers
The purpose of this manual is to define a limited number of indicators that will objectively describe the management and use of antimicrobials in hospitals and to provide tools and step-by-step instructions for designing and carrying out an assessment of antibiotic use and management in hospitals. T...he indicators in this manual will complement the existing WHO (1993) indicators of outpatient antimicrobial use suggested in How to Investigate Drug Use in Health Facilities (including percentage of encounters in which an antibiotic was prescribed and percentage of medicine costs spent on antibiotics) and will address the need for antimicrobial indicators for inpatient conditions.
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The information in this report is up-to-date as of June 2016.
The report, which follows a field visit to the country between 28 May and 6 June, also emphasises the need for international organisations to be mindful of the long present efforts of Greek lawyers and NGOs in the field, and recommends... that new initiatives should be targeted and sustainable.
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The publication describes techniques of narrative therapy discussed in a workshop series for Jiyan Foundation staff members by David Denborough (Dulwich Center Foundation). The publication also includes contributions from local staff reporting on self-assertion and survival strategies of Kurdish fam...ilies
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Persons with disabilities are one of the most vulnerable and socially excluded groups in any crisis-affected community. They may be in hidden in homes, overlooked during needs assessments and not consulted in the design of programs.4 While gender-based violence (GBV) affects women, girls, men and bo...ys, the vast majority of survivors globally are women and girls.5 Persons with disabilities have difficulty accessing GBV programs, due to a variety of societal, environmental and communication barriers, increasing their risk of violence, abuse and exploitation.
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The Malaria Operational Plans below are detailed 1-year implementation plans for PMI focus countries. Each plan reviews the current status of malaria control and prevention policies and interventions, identifies challenges and unmet needs to achieve PMI goals, and provides a description of planned P...MI-funded activities.
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Background Paper prepared for the 2015 Global Assessment Report on Disaster Risk Reduction
The aim of this paper is to help bring voluntary standards into the toolbox of disaster risk reduction, including both by encouraging their use by business and by enhancing their role in legislation and ...regulatory practice.
- Authorities can build awareness for standards in Disaster Risk Reduction (DRR), by facilitating access to relevant standards, encouraging education on DRR-related standards and involving the standardization community.
- Standards need to be sustained by a powerful infrastructure that allows for reliable inspections, audits and precise measurements to be conducted by skilled professionals.
- Risk management best practice needs to embed, as emdodies in standards, more fully in regulatory frameworks in sectors that are relevant.
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Myanmar is prone to various natural hazards that include earthquakes, floods, cyclones, droughts, fires, tsunamis, some of whichhave the potential to impact large numbers of people. In the event that large numbers of people are affected(such as was the case in 2008 following cyclone Nargis), the gov...ernment may decide to request international assistance to respond to the disaster.
The overall goal of the ERPP is to mitigate the impact of disasters and save as many lives as possible from preventable causes. It aims to ensure that effective and timely assistance is provided to people in need through effective coordination and communication on emergency preparedness and humanitarian response between members of the HCTin Myanmar. The approach has been developed in collaboration with the Government, to facilitate a coordinated and effective support to people affected by humanitarian crises.
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This guideline consists of two main parts:
i.) Guidelines for Red Cross and Red Crescent national societies on how to start up and engage with other stakeholders in country in rolling out disaster risk reduction (DRR) education and awareness activities for children - not only in school, but also... in the community;
ii.) Games and activities to engage children with key lessons and messages to carry away. With a focus on Southeast Asia, cases from Viet Nam and Indonesia are highlighted.
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The Demographic Dividend study on Rwanda assessed the socio-economic and human development potential of our country in the short, medium and long-term period using a comprehensive approach. It generated relevant policy and programme information to guide a well-informed polciy required to propel Rwan...da towards achieving its aspirations of being high middle income country by 2035 and high income country by 2050.
The primary objectives of this study were to assess Rwanda’s prospects for harnessing the demographic dividend and demonstrate priority policy and programme options that the country should adopt in order to optimise its chances of earning a maximum demographic dividend in the context of its youthful population and medium, long-term socio-economic development aspirations.
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