WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory system of medical products

WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory system of medical products
Author: World Health Organization
Publisher: World Health Organization
Total Pages: 84
Release: 2024-02-29
Genre: Medical
ISBN: 924008763X
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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.

WHO Expert Committee on Biological Standardization

WHO Expert Committee on Biological Standardization
Author: World Health Organization
Publisher: World Health Organization
Total Pages: 350
Release: 2023-05-26
Genre: Medical
ISBN: 9240074481
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The 76th meeting of the WHO Expert Committee on Biological Standardization was held from 24 to 28 October 2023 by Zoom video conferencing. The meeting was opened on behalf of the Director-General of WHO by Dr Clive Ondari, Director, Health Products Policy and Standards. The Expert Committee on Biological Standardization reviews developments in the field of biological substances used in human medicine, which include vaccines, biotherapeutics, blood products and related substances, and in vitro diagnostic reagents. It coordinates activities leading to: (a) the adoption of WHO guidelines and recommendations for assuring the quality, safety and efficacy of such substances; and (b) the establishment of WHO international standards and other reference materials. The use of international reference materials for designating the activity of biological substances used in prophylaxis or therapy, or for ensuring the reliability of quality control or diagnostic procedures, allows for the comparison of data worldwide. Target audience includes - but is not limited to - regulators, manufacturers, policymakers, health workers, developers of vaccines and other biological products and academia.

Manual for performance evaluation of regulatory authorities seeking designation as WHO-listed authorities

Manual for performance evaluation of regulatory authorities seeking designation as WHO-listed authorities
Author: World Health Organization
Publisher: World Health Organization
Total Pages: 272
Release: 2023-11-14
Genre: Medical
ISBN: 9240076964
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This manual provides operational and technical details for the performance evaluation (PE) exercise that must be conducted for a regulatory authority (RA) to achieve listing as a WHO-listed authority (WLA) in relation to each regulatory function. The PE manual should be read in conjunction with the Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed authorities (“The Operational Guidance”). For the purposes of this document the term regulatory authority (RA), unless otherwise stated, may refer to either a national regulatory authority (NRA) or a regional regulatory system (RRS). The basis for designation as a WLA is provided by the Global Benchmarking Tool (GBT), which is complemented by a series of PE activities designed to establish a detailed picture of how the regulatory system performs on relevant regulatory processes, including how consistently it adheres to quality procedures and how well it delivers the desired regulatory outputs in accordance with good regulatory practices.

Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed authorities

Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed authorities
Author: World Health Organization
Publisher: World Health Organization
Total Pages: 44
Release: 2023-11-14
Genre: Medical
ISBN: 9240074767
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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.

Plotkin's Vaccines,E-Book

Plotkin's Vaccines,E-Book
Author: Walter A. Orenstein
Publisher: Elsevier Health Sciences
Total Pages: 2574
Release: 2022-12-21
Genre: Medical
ISBN: 0323790593
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From the latest vaccination evidence, recommendations, and protocols . . . to new vaccine development and the use of vaccines in reducing disease, Plotkin's Vaccines, 8th Edition, covers every aspect of vaccination. Now completely revised and updated from cover to cover, this award-winning text continues to provide reliable information from global authorities, offering a complete understanding of each disease, as well as the latest knowledge of both existing vaccines and those currently in research and development. Described by Bill Gates as "an indispensable guide to the enhancement of the well-being of our world," Plotkin's Vaccines is a must-have reference for current, authoritative information in this fast-moving field. - Contains all-new chapters on COVID-19, vaccine hesitancy, and non-specific effects of vaccines, as well as significantly revised content on new vaccine technologies such as mRNA vaccines, emerging vaccines, and technologies to improve immunization. - Presents exciting new data on evolution of adjuvants across the centuries, dengue vaccines, human papillomavirus vaccines, respiratory syncytial virus vaccines, tuberculosis vaccines, and zoster vaccines. - Provides up-to-date, authoritative information on vaccine production, available preparations, efficacy and safety, and recommendations for vaccine use, with rationales and data on the impact of vaccination programs on morbidity and mortality. - Provides complete coverage of each disease, including clinical characteristics, microbiology, pathogenesis, diagnosis, and treatment, as well as epidemiology and public health and regulatory issues. - Keeps you up to date with information on each vaccine, including its stability, immunogenicity, efficacy, duration of immunity, adverse events, indications, contraindications, precautions, administration with other vaccines, and disease-control strategies. - Covers vaccine-preventable diseases, vaccine science, and licensed vaccine products, as well as product technologies and global regulatory and public health issues. - Analyzes the cost-benefit and cost-effectiveness of different vaccine options. - Helps you clearly visualize concepts and objective data through an abundance of tables and figures. - Enhanced eBook version included with purchase. Your enhanced eBook allows you to access all of the text, figures, and references from the book on a variety of devices.

Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade.

Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade.
Author: World Intellectual Property Organization
Publisher: WIPO
Total Pages: 352
Release: 2020-07-28
Genre: Law
ISBN: 9280531743
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This study seeks to reinforce the understanding of the interplay between the distinct policy domains of health, trade and intellectual property, and of how they affect medical innovation and access to medical technologies. The second edition comprehensively reviews new developments in key areas since the initial launch of the study in 2013.

Universal Health Coverage Partnership annual report 2022

Universal Health Coverage Partnership annual report 2022
Author: World Health Organization
Publisher: World Health Organization
Total Pages: 136
Release: 2024-07-31
Genre: Medical
ISBN: 9240089349
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The UHC Partnership (UHC-P) is a collaborative agreement between WHO, several donors (namely: the EU, the Grand Duchy of Luxembourg, Irish Aid, the Government of Japan, the French Ministry for Europe and Foreign Affairs, Germany, Canada, Belgium and the UK Department for International Development) and a number of partner countries (currently, 125 partner countries across all six WHO regions) to support policy dialogue on national health policies, strategies, and plans (NHPSPs) and UHC -and it is part of the WHO Special Programme on Primary Health Care (SP-PHC). Its overall objective being to improve health sector results in concerned countries, it aims at building country capacities (and strengthening country processes) for the development, negotiation, implementation, monitoring and evaluation of robust and comprehensive NHPSPs with a view on promoting UHC; health in all policies; and people-centered primary care -as indeed, investments in quality primary health care (PHC) will be the cornerstone for achieving UHC around the world. The purpose of this publication is to document accomplishments of the UHC-P in 2022 for the 125 partner countries. The annual UHC-P report serves as a single report to all nine donors supporting the Partnership. It will provide a synthesis of activities and results achieved in all the participating countries; present a range of country examples related to the major areas of work; and also elaborate on how the UHC-P achieved sustainable buy-in of partners and stakeholders at the country level in the different countries concerned.