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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Cryptococcal disease is one of the most common opportunistic infections among people living with advanced HIV disease and is a major contributor to severe illness, morbidity, and mortality, particularly in sub-Saharan Africa.
These guidelines update the recommendations that were first released i...n 2018 on diagnosing, preventing, and managing cryptococcal disease. In response to important new evidence that became available in 2021, these new guidelines strongly recommend a single high dose of liposomal amphotericin B as part of the preferred induction regimen for the treatment of cryptococcal meningitis in people living with HIV. This simplified regimen - a single high dose of liposomal amphotericin B paired with other standard medicines (flucytosine and fluconazole) - is as effective as the previous WHO standard of care, with the benefits of lower toxicity and fewer monitoring demands.
The objective of these guidelines is to provide updated, evidence-informed recommendations for treating adults, adolescents and children living with HIV who have cryptococcal disease. These guidelines are aimed at HIV programme managers, policymakers, national treatment advisory boards, implementing partners and health-care professionals providing care for people living with HIV in resource-limited settings with a high burden of cryptococcal disease.
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The aim of the people-centred framework is to help countries to develop fully prioritized and budgeted NSPs based on a culture of making full use of the available data, which are aligned with national planning cycles and which provide the basis for a robust national response that can accelerate prog...ress towards the goal of ending TB. In addition, applying the framework for other possible applications according to the country’s planning and policy cycle encourages the culture of data utilization and evidence translation into decision making and planning.
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The purpose of this Guide is to set out a simple, user-friendly, step-by-step approach for conducting table-top exercises for use in countries. These are generic guidelines which may be adapted for use at all levels in a country.
The scope of this PPC document is to serve as a guide to address the unmet public health need for a PPE system that protects the HW-F in tropical climate
s while caring for patients and providing heavy duty essential health services.
The characteristics described in this guidance are targeted fo...r PPE used in
health clinics, hospitals and communities in low resource settings where there is lack of advanced environmental controls and equipment. The purpose is to ensure harmonization in PPE design and its use to avoid confusion and exacerbating the risk of infections in HW-F. The principles of this PPC document can also be considered in risk reduction strategies
in other healthcare settings.
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Antibiotic Stewardship (AS) is a coordinated program that promotes the appropriate use of antimicrobials to improve patient outcomes, reduce microbial resistance, and decrease the spread of multi-drug resistant organisms. In clinical settings, stewardship activities focus on measuring and improving ...how antibiotics are prescribed by clinicians and used by patients. Improving antibiotic prescribing involves implementing effective strategies to modify prescribing practices to align them with evidence-based recommendations for diagnosis and management.
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The goal of the global outbreak response for monkeypox is to stop human-to-human transmission of monkeypox, with a priority focus on communities at high risk of exposure which may differ according to context, and to effectively use strong public health measures to prevent onward spread of the diseas...e. Judicious use of vaccines can support this response. This interim guidance, developed with the advice and support of the Strategic Advisory Group of Experts (SAGE) Working Group on smallpox and monkeypox vaccines, provides the first WHO recommendations on vaccines and immunization for monkeypox. Key points follow.
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Overview
Learning objectives
• Promote respect and dignity for people with depression.
• Recognize common symptoms of depression.
• Know the assessment principles of depression.
• Know the management principles of depression.
• Perform an assessment for depression.
• Use effective... communication skills in interactions with people with depression.
• Assess and manage physical health conditions as well as depression.
• Assess and manage emergency presentations of depression (see Module: Self-harm/
suicide).
• Provide psychosocial interventions for people with depression and their carers.
• Deliver pharmacological interventions as needed and appropriate, considering special
populations.
• Plan and perform follow-up for depression.
• Refer to specialists and link with outside services where appropriate and available.
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- The Role of Plant Nutrition in Supporting Food Security
- Micronutrient Malnutrition: Causes, Prevalence, Consequences and Interventions
- Fertilizer Application and Nutraceutical Content in
Health-Functional Foods
- Plant Nutrition and Health Risks Associated with Plant Diseases
- Human Heal...th Issues Associated with Nutrient Use in Organic
and Conventional Crop Production
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Camps is intended to help address the absence of public and standardized training resources for those seeking to use high resolution satellite imagery in support of refugee/IDP assistance operations. Students, general audiences, and volunteers studying and analyzing satellite imagery of displaced po...pulation camps may find this training resource beneficial.
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The aim of the WHO QualityRights tool kit is to support countries in assessing and
improving the quality and human rights of their mental health and social care facilities.
The tool kit is based on an extensive international review by people with mental disabilities
and their organizations. It ha...s been pilot-tested in low-, middle- and high-income
countries and is designed to be applied in all of these resource settings.
In this tool kit, the term ‘people with mental disabilities’ can include those with mental,
neurological or intellectual impairments and those with substance use disorders.
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At least half of the world’s population does not have full coverage of essential health services. Health expenses push more than 100 million people into extreme poverty each and every year, forcing them into terrible choices that no one should ever have to make: Buy medicine or food? Education or ...health care? These stark statistics make the case for universal health coverage compelling.
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India contributes to 16% of the global maternal deaths and around 27% of global newborn deaths. Reducing the burden of maternal and newborn mortality and morbidity in urban poor settings today requires an expansion of effective Maternal and Newborn Health (MNH) care services and lowering the barrier...s to the use of such services, especially availability and accessibility.
For designing sensitive, responsive and relevant urban health policy and action, it is important for planners and programme managers to understand the context with regard to current systems and mechanisms, potential organisations and best practices.
In order to adres this need, Save the Children’s Saving Newborn Lives programme commissioned a study that reviewed the literature and looked at available secondary data on MNH in urban poor settings.
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