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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
more
This field guide is designed for use by FHI 360 staff and partner organizations responsible for ensuring quality clinical services, at both facility and non-facility levels. The guide provides general information on how to organize, implement and fo
...
llow up on quality assurance/quality improvement clinical facility and service assessments.
The accompanying checklists are intended to be used with the clinical facility assessment guide.
more
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.
more
This policy document is to guide the Traditional, Complimentary and Alternative Medicine practices in Rwanda. The various elements examined under the policy include, legislation and regulatory control, registration, manufacture, procurement and supply management, rational use,
...
quality assurance, co-ordination, monitoring and evaluation of Traditional, Complementary and Alternative Medicine practices.
more
The document, "Sustainable Management of Radiotherapy Facilities and Equipment," by WHO and IAEA, provides guidelines for managing radiotherapy equipment and facilities to ensure effective and safe cancer treatment. It covers essential aspects like preventive and corrective maintenance, funding, inf
...
rastructure, and staffing requirements for sustainable operation. The document aims to support radiotherapy departments, especially in low-resource settings, by outlining strategies for equipment procurement, maintenance, and replacement, emphasizing safety, quality assurance, and optimal patient care.
more
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
more
The meeting was held from 26 to 27 March 2018 to review and discuss the following topics:
Advances and challenges in the use of fTLC, and new approaches to detecting mycolactone using monoclonal antibodies (mAbs).
The status of development of rapid diagnostic tests (RDTs) targeting the MUL
...
_3720 protein.
The role of PCR as a reference test, and hurdles in providing a confirmatory diagnosis and in establishing a quality assurance programme.
New molecular tools with potential for implementation at a level lower than in the national or regional reference laboratory, such as loop-mediated isothermal amplification (LAMP) and recombinase polymerase amplification (RPA).
The need to harmonize and standardize methods for collection and preparation of specimens, so samples can be referred for diagnosis and stored for evaluation of new diagnostic tests in optimal conditions.
Barriers to accessing early diagnosis and treatment, including coordination at the programme level, and lack of adequate diagnostic tools.
Defining target product profiles (TPPs) to guide the development of new diagnostic tools that can be applied at different levels of the health system. Participants agreed that two TPPs would be developed to address the current gaps: (i) a rapid test for BU diagnosis at the primary health-care level; and (ii) a test for diagnosis of BU that can also assist in treatment monitoring and differential diagnosis at the district hospital or reference centre.
more
Antimicrobial Resistance Surveillance and Research Network | This manual describes well accepted methods to carry out drug susceptibility testing on important gram positive and gram negative clinically relevant bacteria. Methods of specimen collection, transport, culture, anti-microbial drug suscept
...
ibility testing (common, special phenotypic and
molecular techniques) as well as quality control and quality assurance have been described in a concise manner.
more
This codebook outlines the set of TUFF procedures that have been developed, tested, refined, and implemented by AidData staff and affiliated faculty at the College of William & Mary. We initially employed these methods to achieve a specific objective: documenting the known universe of officially fin
...
anced Chinese projects in Africa (Strange et al. 2013, 2017). We have since then employed these methods to track Chinese official finance to five major world regions: Africa, the Middle East, Asia and the Pacific, Latin America and the Caribbean, and Central and Eastern Europe (Dreher et al. 2017). Additionally, other social scientists have adapted and applied the TUFF methodology to identify grants and loans from Gulf Cooperation Council (GCC) members (Minor et al. 2014), under-reported humanitarian assistance flows from traditional and non-traditional sources (Ghose 2017), foreign direct investment from Western and non-Western sources (Bunte et al. 2017), and pre-2000 foreign aid flows from China (Morgan and Zheng 2017). However, this codebook focuses specifically on TUFF data collection and quality assurance procedures to track Chinese official finance between 2000 and 2014.
more
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.
more
What are the FP and CAC competencies?
Through the clear articulation of the family planning and comprehensive abortion care (FP and CAC) competencies for the primary health care workforce, the aim is to advance improvements in FP and CAC service delivery by aligning health worker education approach
...
es with population health needs and health system demands.
This document, which describes these competencies in detail, is intended to:
be a foundational tool to be adopted and adapted by educators and regulators for FP and CAC providers (students) with a pre-service training pathway of at least 12 months;
describe competencies that are relevant to current and future health practice;
enable widespread use of the competencies not only for curriculum development for pre-service education, but also for in-service education, regulation, qualifications, quality assurance, personal development, performance evaluation, recruitment, management and career progression;
focus on the core functions of FP and CAC providers within broader efforts towards achieving universal health coverage
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,
...
quality assurance, national procurement and reimbursement schemes of these medicines.
more
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
more
Accessed: 02.05.2020
These interim IPC recommendations for health settings have been developed through the contributions of many individuals and institutions, such as the Centers for Disease Control-Kenya; ITECH; US Agency for International Development (USAID) Medicines, Technologies, and Pharmaceu
...
tical Services (MTaPS) Program; and WHO that are committed to ensuring that the transmission of COVID-19 to HCWs and the public within the health care setting is limited. The Ministry of Health (MOH) through the Directorate of Health Standards Quality Assurance and Regulations wishes to thank all the contributing authors led by the sub-committee on case management and IPC for the COVID-19 response for their expertise and time given to writing these guidelines.
more
How to procure CycleBeads: a visual tool for the Standard Days Method
World Health Organization
(2012)
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
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n accordance with a specification and quality-assurance assessment
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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
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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
more
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
more
The National pharmaceutical policy aligns itself to the Government vision for development of the health sector, as defined in Vision 2020, the Millennium Development Goals and the Economic Development for Poverty Reduction Strategy and the National Health Policy. The pharmacy policy addresses, among
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other challenges, the establishment of functional National Medicines Regulatory Authority that will implement all the regulatory functions, lack of local manufacturing facilities, lack of pricing policy of health commodities and technologies in private sector. This policy is based on the following key priorities: the Quality assurance, accessibility and the rational use of medicines, other health commodities and technologies.
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Control of pollution from antibiotic manufacturing is a key part of safeguarding the longevity of antibiotics for all. Pollution contributes to antibiotic resistance and potentially undermines the effectiveness of medicines. High levels of antibiotics in water bodies downstream of manufacturing site
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s have been widely documented. Currently, antibiotic pollution from manufacturing is largely unregulated and quality assurance criteria typically do not address environmental emissions.
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