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 guidelines are primarily intended for health-care professionals working in first- or second-level health-care facilities, including emergency, inpatient and outpatient services. They are also directed at policy-makers, health-care planners and programme managers, academic institutions, non-gover...nmental and civil society organizations to inform capacity-building, teaching and research agendas.
Web annex A provides the quantitative evidence reports, Web annex B summarizes the qualitative and economic evidence and Web annex C presents the Evidence-to-Decision frameworks.
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Breaking Barriers is an implementation research project focusing on social and behavioural change. It is conducted in conflict-affected communities in Cameroon. The project explores three innovative, community-based interventions designed to improve health behaviours. This presentation outlines the ...project's context, methodology and implementation process. It also shares qualitative insights and field perspectives, reflecting on key lessons learned for future SBC efforts in fragile settings.
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Offering additional pre-exposure prophylaxis (PrEP) choices has the potential to increase uptake and effective use of PrEP, and of HIV prevention overall, as it allows people to choose a method that they prefer.
In this guideline, WHO recommends an offering long-acting injectable lenacapavir (LEN...) as an additional HIV prevention choice, as part of combination HIV prevention approaches. LEN, administered twice a year as PrEP, has been shown to be highly effective at reducing the risk of HIV acquisition. In this guideline, WHO also recommends using HIV rapid diagnostic tests (RDTs) for individuals initiating or continuing long-acting injectable PrEP, such as LEN and long acting injectable cabotegravir (CAB-LA). Flexible HIV testing approaches are essential for ensuring that testing does not become a barrier to accessing or continuing PrEP, including long-acting injectable options.
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Guidelines on lenacapavir for HIV prevention and testing strategies for long-acting injectable pre-exposure prophylaxis. Web Annex B
These guidelines promote the delivery of people-centred health services for STIs by providing evidence-based recommendations related to decentralization, integration, task sharing and digital health. These recommendations complement existing WHO guidelines for STI testing, treatment and management, ...and other service delivery interventions, such as self-care interventions. All the recommendations will be incorporated into the forthcoming WHO consolidated guidelines on STI prevention and care.
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This policy brief presents a summary of current evidence on vulnerability to TB and proposes interventions for equitable, person-centred, and human rights-based TB prevention and care. It aligns with WHO policies and guidance on TB prevention and screening, management of TB and comorbidities, access... to health care, universal health coverage, determinants of TB, TB-associated impairment and disability, social protection, as well as ethics, equity and human rights.
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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 guide provides strategic direction for host countries, event organizers, health authorities, and key stakeholders to effectively plan and conduct Simulation Exercises (SimEx) and After Action Reviews (AARs) for mass gathering events. Packed with practical tools, it empowers users to seamlessly ...integrate these activities into ongoing learning and emergency risk management processes. Aligned with the International Health Regulations (IHR, 2005), the guide serves as a critical resource for strengthening global and national health resilience, ensuring safer and more prepared mass gatherings.
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Integrated Outbreak Analytics (IOA) applies a multidisciplinary approach to understanding outbreak dynamics and to inform outbreak response. It aims to drive comprehensive, accountable, and effective public health and clinical strategies by enabling communities, and national and subnational health a...uthorities to use data for operational decision-making. IOA embraces a holistic perspective of outbreak dynamics throughout: from the trigger questions to the data that are collected or accessed, to the interpretation of results and the recommendations that follow. In addition, IOA promotes co-development and monitoring of evidence informed actions.
The IOA toolkit aims to provide a clear understanding of IOA and highlight the importance of using an integrated, holistic approach to manage outbreak responses. It provides step-by-step guidance for setting up IOA and putting IOA principles into action. Finally, this toolkit provides guidance on applying IOA in humanitarian and emergency contexts, offering a practical and adaptable approach to informing public health emergency responses.
Developed based on the model from the Democratic Republic of the Congo (DRC), its creation involved extensive consultation with experts experienced in IOA applications. The toolkit was piloted in Tanganyika Province, DRC, as well as Somalia and Sudan, demonstrating its adaptability to diverse emergency scenarios. It builds upon an existing array of tools, templates, reports, case studies, animations, and publications used by stakeholders in diverse contexts.
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A broad range of UNHCR’s key priorities overlap with MHPSS issues – for example, child protection and sexual and gender-based violence [SGBV] prevention and response.
Despite all these existent synergies, UNHCR’s current policies and guidelines do not sufficiently link with MHPSS principles.... For example, the Community Services section, which is closely aligned to the principles of MHPSS and could be well-positioned to guide the implementation of related programs, has not adopted the MHPSS language or approach.
There are opportunities for UNHCR to engage more strongly and clearly in this field. However, this requires a vision for how the organisation as a whole, and particular sectors within the organisation, will engage within the field of MHPSS activities. For a start, UNHCR can work to improve its understanding and framing of mental health and psychosocial issues, and how these issues fit within its broader mandate.
While the majority of MHPSS activities are delivered by implementing partners, UNHCR staff require familiarity with core principles in the field, such as the Intervention Pyramid contained in the IASC Guidelines, in order to support and monitor quality MHPSS activities.
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This report aims to raise awareness about the role that the reform of public health laws can play in advancing the right to health and in creating the conditions for people to live healthy lives. By encouraging a better understanding of how public health law can be used to improve the health of the ...population, the report aims to encourage and assist governments to reform their public health laws in order to advance the right to health.
The report highlights important issues that may arise during the process of public health law reform. It provides guidance about issues and requirements to be addressed during the process of developing public health laws. It also includes case studies and examples of legislation from a variety of countries to illustrate effective law reform practices and some features of effective public health legislation.
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Blueprint for EECA countries, first edition
Patient safety standards are critical for the establishment and assessment of patient safety programmes within hospitals. This third edition of the Patient safety assessment manual provides an updated set of standards and assessment criteria that reflect current best practice and WHO guidance. The m...anual will support the implementation of patient safety assessments and improvement programmes within hospitals as part of the Patient Safety Friendly Hospital Framework to ensure that patient safety is prioritized and facilities and staff implement best practices. The manual is a key tool for use by professional associations regulatory accrediting or oversight bodies and ministries of health to improve patient safety.
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