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
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 districts, 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
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 quality, safety and efficacy of finished herbal products;
2. guide the formulation of national and/or regional GACP guideli...nes 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.
more
MEDBOX – The Aid Library is an open-access online library aiming to increase the quality of health care worldwide. Quality assurance and accountability are important values in humanitarian action as well as healthcare settings, which receive growing attention by affected populations, health care w...orkers, 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
• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to facilitate 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 facilitate 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 facilitate 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 facilitate 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
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 management considerations for COVID-19 self-testing. The Africa CDC recommends the use of rapid antigen sel...f-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 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 for 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.
more
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
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
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 rehabilitation, operation and maintenance unconditionally needed.
• There is a need to maintain the provis...ion 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.
more
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.
more
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.
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
The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the la...test practical guidance on use of newly recommended diagnostics as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostic connectivity, biosafety, data management, human resources, strategic planning, and model algorithms. The key changes are:
inclusion of recent or updated WHO recommendations for tests to diagnose TB and detect drug resistance;
alignment with the latest WHO critical concentrations for phenotypic drug-susceptibility testing (DST) and the new definitions of pre-XDR-TB and XDR-TB;
updated information on building quality-assured TB testing and management capacity using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) approach (Score-TB package1);
updated information on assessing, analysing and optimising TB diagnostic networks; and
updated information on the use of next-generation sequencing (NGS) to detect mutations associated with drug resistance for surveillance purposes.
The document also provides references to resources and tools relevant for work on laboratory strengthening.
more
Thesis presented in partial fulfilment of the requirements for the degree of Master of Nursing Science in the Faculty of Health Sciences at Stellenbosch University.
The mobile clinic health care services fulfil an essential role in delivering primary health care to the dwellers in the rural commun...ities of the Western Cape. However, occupational health and safety, as well as quality assurance are issues that need to be addressed urgently. It is thus recommended that policy makers take cognizance of the specific needs of every individual mobile clinic team.
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
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