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The Legitimation of Healthcare Products Regulatory Agencies
Healthcare products regulatory agencies, as any regulatory agency, have a vital need for legitimacy. However, they face specific challenges that impair the traditional model, founded on expertise and autonomy: complex demonstration of their efficacy, uncomfortable public profile, health-related accidents, high public expectations, technicality of the field, large political dimension and depoliticization. Therefore, they need to establish and master a genuine legitimising system. A system that would empower them to apprehend their legitimacy's limitations and reinforce the influence of deontologism when utilitarianism is insufficient. Open and continuous participation is key in that system, supported by communication tools.
WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory system of medical products
This manual is intended to provide clear operational guidance on the benchmarking of regulatory systems for medical products and the development of institutional development plans (IDPs) to address areas for improvement. The manual is integral to the World Health Organization’s structured and evidence-based approach to regulatory systems strengthening (RSS), mandated by World Health Assembly resolution WHA 67.20. The manual serves to ensure a proper understanding of the Global Benchmarking Tool (GBT); the processes and principles that govern its use; the expectations of individuals and institutions involved; and the information management systems that underpin the collection, analysis and management of data and the generation of knowledge.
Guidance on development and implementation of a national deployment and vaccination plan for vaccines against pandemic influenza and other respiratory viruses of pandemic potential
Vaccines are powerful weapons in the fight against pandemic viruses as shown by responses to both the 2009 H1N1 influenza and the COVID-19 pandemics. However, planning for accessing, allocating and deploying vaccines in a pandemic situation is a complex endeavour, beset with multiple challenges at all levels – local, regional and global. The World Health Organization (WHO) and its partners have prepared this revised guidance document to assist countries update their national deployment and vaccination plans (NDVPs) by leveraging global learnings from past pandemic responses, including the recent COVID-19 vaccination effort. The development and testing of a NDVP would not only advance pandemic preparedness efforts but would also have benefits in terms of increasing national capabilities to manage other health emergencies which require emergency vaccination campaigns.
Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed authorities
The Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed authorities provide procedural information (processes, steps and timelines) and general considerations related to the evaluation and listing of a regulatory authority as a WHO-listed authority (WLA). The guidance also describes the process and criteria for renewal, re-evaluation and possible delisting, the role and responsibilities of the technical advisory group on WLAs (TAG-WLA) and the undertakings of WHO and eligible regulatory authorities.
La légitimation des agences de réglementation des produits de santé
Les agences de réglementation des produits de santé, comme toutes les agences de réglementation, ont un besoin vital de légitimité. Elles font pourtant face à des défis spécifiques qui mettent à mal le modèle classique, basé sur l'expertise et l'autonomie : démonstration difficile de l'efficacité, notoriété inconfortable, accidents sanitaires, fortes attentes du public, technicité du domaine, dimension politique importante et isolement vis-à-vis des élus. Elles ont ainsi besoin de mettre en place et de maîtriser un véritable système de légitimation. Un système qui leur permette d'appréhender les limites de leur légitimité et qui renforce l'influence du déontologisme quand l'utilitarisme fait défaut. L'élément clé d'un tel système est une participation ouverte et permanente, facilitée par les outils de communication.
A History of Transgender Medicine in the United States
The most comprehensive history of transgender medicine to date, as told by more than forty scholars, physicians, psychologists, and activists from trans, gender-diverse, and allied medical communities. Arriving at a critical moment in the struggle for transgender rights, A History of Transgender Medicine in the United States takes an empathic approach to an embattled subject. Sweeping in scope and deeply personal in nature, this groundbreaking volume traces the development of transgender medicine across three centuries-centering the voices of transgender individuals, debunking myths about gender-affirming care, and empowering readers to grasp the complexities of this evolving field. More tha...
Report of the Paediatric Regulatory Network meeting, 12-13 May 2022
The Paediatric Regulatory Network was initially created as a global paediatric working group in February 2010 in response to a recommendation from the 2008 International Conference on Drug Regulatory Authorities and as part of the World Health Organization (WHO) Better Medicines for Children Project in collaboration with the Bill & Melinda Gates Foundation, to offer a platform for discussion on paediatric regulatory considerations for national regulatory authorities. The Network was reactivated in December 2019 as a global paediatric network supporting the availability of quality-assured medical products for children, by facilitating communication, collaboration, training and regulatory harm...
WHO standards for quality, safety and efficacy of health products
To better understand Member State needs for WHO standards and guidelines for the quality, safety and efficacy of health products, a stakeholder feedback survey was conducted on 8 WHO guidelines. This report presents the approach, results, and results analysis regarding the levels of adoption and factors that impede or support adoption of the selected WHO guidelines for health products. The report is useful for those using WHO guidelines and those issuing guidelines.
