Overview

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological substances, and the establishment of international biological reference materials. WHO Guidelines on the quality, safety and efficacy of Ebola vaccines, and WHO Guidelines on procedures and data requirements for changes to approved biotherapeutic products were adopted on the recommendation of the Committee. In addition, the following two WHO guidance documents on the WHO prequalification of in vitro diagnostic medical devices were also adopted: (a) Technical Specifications Series (TSS) for WHO Prequalification - Diagnostic Assessment: Human immunodeficiency virus (HIV) rapid diagnostic tests for professional use and/or self-testing; and (b) Technical Guidance Series (TGS) for WHO Prequalification - Diagnostic Assessment: Establishing stability of in vitro diagnostic medical devices. Subsequent sections of the report provide information on the current status, proposed development and establishment of international reference materials in the areas of: antibiotics, biotherapeutics other than blood products; blood products and related substances; in vitro diagnostics; and vaccines and related substances.

Full Product Details

Author:   World Health Organization
Publisher:   World Health Organization
Imprint:   World Health Organization
Edition:   Web Edition - 1011.1
Volume:   1011
Weight:   0.807kg
ISBN:  

9789241210201

ISBN 10:   9241210206
Pages:   396
Publication Date:   18 July 2018
Audience:   Professional and scholarly ,  Professional and scholarly ,  Professional & Vocational ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   In Print  
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World Health Organization is a Specialized Agency of the United Nations, charged to act as the world's directing and coordinating authority on questions of human health. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends.

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