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. Following a brief introduction, the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report, of particular relevance to manufacturers and national regulatory authorities, outlines the discussions held on the development and adoption of new and revised WHO Recommendations, Guidelines and guidance documents. Following these discussions, WHO Recommendations to assure the quality, safety and efficacy of recombinant hepatitis E vaccines; WHO Guidelines for the safe development and production of vaccines to human pandemic influenza viruses and influenza viruses with pandemic potential; and WHO Guidelines for the safe production and quality control of poliomyelitis vaccines were adopted on the recommendation of the Committee. In addition, a WHO questions-and-answers guidance document on the evaluation of similar biotherapeutic product (SBPs) was also adopted with the Committee recommending that it be posted on the WHO website.

Full Product Details

Author:   World Health Organization ,  K. Cichutek
Publisher:   World Health Organization
Imprint:   World Health Organization
Edition:   Web Edition - 1016.1
Volume:   1016
Weight:   0.540kg
ISBN:  

9789241210256

ISBN 10:   9241210257
Pages:   266
Publication Date:   13 August 2019
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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