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 standard operating procedures (SOP) for referral care cover all the refugee populations living in Lebanon. These SOPs outline the policies and procedures for referral care in Lebanon, including the limits in health assistance that can be provided.
Short Version
This clinical practice guideline was developed in order to provide recommendations for the management of critically ill adult patients with COVID-19 in intensive care units (ICUs).
The seven essential features of practice for scaling up are described with great clarity. They are practical and universal, and encourage local innovation. They include policy, funding and local management structure, as well as working with all possible partners and developing local context adaptati...ons. The case studies give ideas and inspiration to develop new programmes and find ways around obstacles in existing programmes, especially through involving those with most at stake including users and their families and local community leaders
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This document is part three in a series of explainers on vaccine development and distribution. Part one focused on how vaccines work to protect our bodies from disease-carrying germs. Part two focused on the ingredients in a vaccine and the three clinical trial phases.
This document outlines the... next part of the vaccine journey: the steps from completing the clinical trial phases through to distribution.
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A Toolkit for Implementation. Module 1: An Overview of Implementation at National, Province and District Levels
Revised working paper following AVAREF meeting February 2019.
WHO has published a roadmap aiming to coordinate partners’ actions and contributions to the licensing and roll-out of Merck’s Ebola vaccine (VSV-ZEBOV) in African countries. The vaccine was developed during the West Africa Ebola epi...demic of 2014-2016, during which more than 11 000 people lost their lives to the disease. The vaccine was tested in European and African countries at the time and is currently used under an “expanded access” protocol in the Democratic Republic of Congo.
WHO will expedite prequalification and licensing of the vaccine for use in countries at risk of Ebola outbreaks and will coordinate work between those countries’ regulatory authorities and the European Medicines Agency and the US Food and Drug Administration.
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This consultative version of the guideline is the product of literature reviews, discussions and contributions from diverse stakeholders, as well as UNISDR-nominated experts appointed specifically for the development of the Words into Action guideline for Build back better in recovery, rehabilitatio...n and reconstruction.
Disaster impacted countries and communities are oftentimes much better equipped to Build Back Better during the extended period of recovery, rehabilitation, and reconstruction when they have taken actions to strengthen recovery capacity and decision-making effectiveness prior to the onset of disaster.
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