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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WHO recommends artemisinin-based combination therapies for treating uncomplicated malaria, alongside studies to monitor treatment effectiveness. Given the threat of antimalarial resistance, including partial resistance in several African countries, molecular tools are vital for tracking resistance. ...In 2015, WHO launched the External Quality Assessment scheme for nucleic acid amplification testing to ensure reliable lab results. Coordinated by WHO and operated by the United Kingdom National External Quality Assessment Service for Parasitology, the scheme provides quality-controlled specimens and reports to help improve testing accuracy. Experts recently discussed expanding the scheme to include antimalarial resistance markers.
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Anopheles stephensi is an invasive mosquito species which has been found spreading across Africa. While this species presents a new challenge for malaria control on the continent, its surveillance and management have been ongoing in Asia for many years. This document aims to summarize key lessons fr...om 3 countries – India, the Islamic Republic of Iran and Sri Lanka – that have been working to control An. stephensi. It is hoped that their experiences and insights will be valuable for countries encountering An. stephensi for the first time.
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The aim of this protocol is to support the conduct of entomological comparative efficacy assessments for vector control products and the associated non-inferiority analysis. This evidence is used to inform discussions within the guidelines development context as to whether a new vector control prod...uct should be considered as covered by one or more existing WHO recommendations or not. Alternatively, the evidence may inform the extension of an existing WHO recommendation or the development of a new one, provided that non-inferiority is demonstrated
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This toolkit is a comprehensive set of practical tools and resources designed to support country-level risk communication and community engagement (RCCE) practitioners, decision-makers and partners to plan and implement readiness and response activities for Ebola disease outbreaks. The toolkit conta...ins: information about Ebola disease; RCCE considerations on how to approach key issues during Ebola disease outbreaks; tools for understanding the context in which Ebola disease outbreaks occur; methods for collecting data to inform strategy development and bring evidence into the planning and implementation of activities; guidance to support prevention and response interventions; and links to existing RCCE tools and training. It is one of a suite of toolkits on RCCE readiness and response to a range of disease and response areas.
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This toolkit is a comprehensive set of practical tools and resources designed to support country-level risk communication and community engagement (RCCE) practitioners, decision-makers, and partners to plan and implement readiness and response activities for yellow fever outbreaks. The toolkit conta...ins: information about yellow fever; RCCE considerations for how to approach key issues during yellow fever outbreaks; tools for understanding the context in which yellow fever outbreaks occur; methods for collecting data to inform strategy development and bring evidence into planning and implementation of activities; guidance to support vector control and immunization campaigns; and links to existing RCCE tools and training. It is one of a suite of toolkits on RCCE readiness and response to a range of disease and response areas.
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This toolkit is a comprehensive set of practical tools and resources designed to support country-level risk communication and community engagement (RCCE) practitioners, decision-makers, and partners to plan and implement readiness and response activities for yellow fever outbreaks. The toolkit conta...ins: information about yellow fever; RCCE considerations for how to approach key issues during yellow fever outbreaks; tools for understanding the context in which yellow fever outbreaks occur; methods for collecting data to inform strategy development and bring evidence into planning and implementation of activities; guidance to support vector control and immunization campaigns; and links to existing RCCE tools and training. It is one of a suite of toolkits on RCCE readiness and response to a range of disease and response areas.
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This Plan envisions a future with the elimination of cervical cancer as a public health problem as a result of universal access to sexual health and STI prevention services, HPV vaccines, effective screening and precancer treatment services, treatment of invasive cervical cancer, and palliative care.... It foresees that all women and girls, regardless of age, race, ethnicity, socioeconomic status, HIV status, or disability will have timely access to quality cervical cancer prevention, care, and treatment so that they can live in good health throughout the life course and enjoy the health-related human rights.
The goal is to accelerate progress toward the elimination of cervical cancer as a public health problem in the Americas by reducing incidence and mortality rates by one-third by 2030.
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The Newborn Situational Analysis reports of 2009 and 2011, as well as the “Bottleneck analysis on neonatal health” of 2013, culminated in the Nigeria launch of “Call to action on Newborn health” at the first National Newborn Health Conference in 2014. This call to action provided the framewo...rk for the development of the Nigeria Every Newborn Action
Plan (NiENAP). The NiENAP lays out a vision to end preventable stillbirths and newborn deaths by accelerating progress and scaling up evidence- based high-impact and cost effective interventions. The plan is guided by the principles of country-leadership, integration, accountability, equity, human rights, innovation and research. This blue print outlines our commitment as government and stakeholders to repositioning newborn health as we implement approaches that impact on the lives of newborns for improved health outcome.
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Recommendations on the initiation and continuing use of nine common types of contraceptive methods are covered by the tool. In addition to looking at individual medical conditions or characteristics, users may also easily combine multiple conditions or characteristics and view the guidance on each c...ondition separately or in combination.
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While much progress has been achieved over the past year, the Region of the Americas has stubbornly remained the epicenter of the COVID-19 pandemic. PAHO is launching its 2021 COVID-19 Response Strategy and Donor Appeal to continue supporting Latin American and Caribbean countries and territories i...n their fight against COVID-19. This document outlines PAHO’s regional strategy for the year 2021 to sustain and scale-up the response to COVID‑19 pandemic in the Americas, suppress the community transmission of the virus and mitigate the longer-term health impact of the pandemic.
US$ 239 million is needed to support critical response efforts in the Americas between 1 January and 31 December 2021
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4th edition 2022 of the Handbook includes new WHO recommendations that expand contraceptive choices. Also, guidance on starting ongoing contraception following emergency contraception is provided.
Drawing on lessons from recent outbreaks, this new edition details tangible me...asures for frontline health workers to protect access to family planning services during emergencies, such as wider access to self-administered contraceptives and the use of digital technologies by providers. It also expands guidance for women and young people at high risk of HIV.
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This new edition and fully updated publication replaces the 2012 UCG and is being circulated free of charge to all public and private sector prescribers, pharmacists, and regulatory authorities in the country