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 main objectives of these guidelines are to:
1. contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines to improve the ...-to-highlight medbox">quality, safety and efficacy of finished herbal products;
2. guide the formulation of national and/or regional GACP guidelines and GACP monographs for medicinal plants and related standard operating procedures; and
3. encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general.
These guidelines concern the cultivation and collection of medicinal plants and include certain post-harvest operations.
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MEDBOX – The Aid Library is an open-access online library aiming to increase the quality of health care worldwide. Quality assurance and accounta...bility are important values in humanitarian action as well as healthcare settings, which receive growing attention by affected populations, health care workers, humanitarian actors, donors and the public.
Videoclip Series "MEDBOX - The Aid Library" no.1
You can view different language versions: German, English, French, Portuguese, Russian and Spanish
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Through the USAID-funded Organized Network of Services for Everyone’s Health (ONSE) Activity, MSH is assisting Malawi’s National Malaria Control Program to provide high-quality malaria services at the facility and community levels in 10 district...s, covering nearly a third of the country.
Our team in Malawi share recent results on strengthening malaria services through Outreach Training and Supportive Supervision (OTSS).
Designed to provide ongoing support to clinicians, data, and laboratory staff, OTSS combines a standardized checklist with targeted mentorship and supportive supervision to identify areas for improvement and strengthen clinical and diagnostic services in health facilities.
This webinar shares lessons learned on how the application of OTSS, as part of broader quality assurance systems, impacts staff performance and improves the provision and quality of malaria services.
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• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to fac...ilitate their appropriate use in Member States;
• provide models to assist Member States in developing their own mono- graphs or formularies for these or other herbal medicines; and
• facilitate information exchange among Member States.
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• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to fac...ilitate their appropriate use in Member States;
• provide models to assist Member States in developing their own mono- graphs or formularies for these or other herbal medicines; and
• facilitate information exchange among Member States.
more
• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to fac...ilitate their appropriate use in Member States;
• provide models to assist Member States in developing their own mono- graphs or formularies for these or other herbal medicines; and
• facilitate information exchange among Member States.
more
• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to fac...ilitate their appropriate use in Member States;
• provide models to assist Member States in developing their own mono- graphs or formularies for these or other herbal medicines; and
• facilitate information exchange among Member States.
more
Interagency Guidelines - This revised Interagency List of Essential Medicines for Reproductive Health presents
the current international consensus on rational selection of essential reproductive health medicines. The list is intended to support decisions regarding the production, ...ibute-to-highlight medbox">quality assurance, national procurement and reimbursement schemes of these medicines.
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CycleBeads is a visual tool that helps women use a fertility-awareness-based method known as the Standard Days Method, as an effective natural family planning method. This advisory note has been prepared to explain the purpose of CycleBeads and the procedure that should be followed to procure them i...n accordance with a specification and quality-assurance assessment
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The workshop is structured around 13 learning modules. The first module (Introduction) gives an overview of WSPs. The last module (Module 12) introduces participants to the quality assurance tool fo...r WSPs (WHO & IWA, 2012). Modules 1–11 relate explicitly to the WSP manual produced by IWA and WHO (Bartram et al., 2009), from which the workshop is designed.
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This guidance addresses rationale, risk-based scenarios, practical considerations prior to adoption of the self-testing products, quality assurance, safety and ethical considerations, and data manag...ement considerations for COVID-19 self-testing. The Africa CDC recommends the use of rapid antigen self-testing within two key scenarios. The first includes testing for case identification within scenarios with a high risk of infection, including symptomatic cases and contacts of a confirmed case. The second scenario involves general screening within scenarios of low or unknown risk exposure allowing for self-care such as before gatherings with at-risk individuals and prior to participation in events involving members of different households. Within these scenarios, a positive test result indicates likelihood of current infection, while a negative test result indicates a lower risk of active infection, though it does not rule out infection altogether. All positive cases should be managed following the national COVID-19 management protocol of Member States.ssur
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SITUATION ANALYSIS
• In Syria, nine years into the crisis, access to sucient quantities of safe water remains limited, with increased water quality assurances and support to water systems rehabil...itation, operation and maintenance unconditionally needed.
• There is a need to maintain the provision of adequate WASH services and supplies for IDPs especially in the northeast and northwest, and to promote transition to more sustainable solutions while acknowledging that more emphasis on IDPs in collective centers and open areas is also needed.
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The National Guidelines for HIV-1 Viral Load Laboratory Testing support plans to scale up viral load (VL) testing to reach the 90-90-90 targets in India. This phased scale-up includes the setup of 70 additional VL testing laboratories nationally. These guidelines include laboratory design considerat...ions, a summary of VL technologies, and specimen collection and handling as well as transportation and storage guidance. Quality control and quality assurance requirements are described as well as laboratory safety issues. The guidelines also describe the VL laboratory network to be developed with supply chain management issues and commodities described. Annexes include laboratory registers and reporting forms.
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Types of radiotherapy equipment covered by the guide include external beam radiotherapy machines (both Cobalt-60 and linear accelerators), brachytherapy devices that apply radiation sources directly to tumours and complementary imaging devices such as conventional or computed tomography (CT) simulat...ors, as well as other tools essential for safe operation and quality control. Depending on the type of radiotherapy machine, the need for specialized professionals and infrastructure, as well as quality assurance and maintenance, may vary.
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This chronology of facts has challenged public health systems worldwide and regulatory bodies are no exception. Regulatory authorities with mechanisms in place to authorize the use of investigational products had to development guidelines and procedures, create task forces and alliances to maximize ...the efficiency of assessment, review and authorizations of medical products. Vaccines are undoubtedly the most complex medical products to develop, from concept to a stage where sufficient evidence of quality, safety and efficacy are collected to provide an assurance that their use will provide more benefits than risks when used in the context of a public health emergency.
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A technical guide for sputum smear microscopy, initiated by the International Union against Tuberculosis, is designed to be an easy to use reference standard for the collection, storage and transport of sputum specimens and for the examination of sputum smears by direct microscopy. This edition incl...udes updates addressing bio-safety and quality assurance aspects of sputum smear microscopy.
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The modules (1-12) are based on materials originally developed by FIND, KNCV and Cepheid, and are in PowerPoint format for country customization. Depending on the audience, modules may be selected and adapted according to need (e.g. basic users, supervisors, clinicians). Topics covered include: Over...view of TB and diagnostics, biosafety, specimen collection, procurement, installation, Xpert MTB/RIF technology, results interpretation, reporting, troubleshooting, maintenance, a clinical guide, and quality assurance.
Please download each manual directliy from the website
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The modules (1-12) are based on materials originally developed by FIND, KNCV and Cepheid, and are in PowerPoint format for country customization. Depending on the audience, modules may be selected and adapted according to need (e.g. basic users, supervisors, clinicians). Topics covered include: Over...view of TB and diagnostics, biosafety, specimen collection, procurement, installation, Xpert MTB/RIF technology, results interpretation, reporting, troubleshooting, maintenance, a clinical guide, and quality assurance.
Please download each manual directliy from the website
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Комплект учебных материалов по Xpert MTB/RIF
The modules (1-12) are based on materials originally developed by FIND, KNCV and Cepheid, and are in PowerPoint format for country customization. Depending on the audience, modules may be selected and adapted according to nee...d (e.g. basic users, supervisors, clinicians). Topics covered include: Overview of TB and diagnostics, biosafety, specimen collection, procurement, installation, Xpert MTB/RIF technology, results interpretation, reporting, troubleshooting, maintenance, a clinical guide, and quality assurance.
Please download each manual directliy from the website
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