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World Health Organization : Technical Report Series, No. 932 - in English: World Health Organization Technical Report Series ; World Health Organization Expert Committee on Biological Standardization, No. 932

By World Health Organization

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Book Id: WPLBN0000063398
Format Type: PDF eBook
File Size: 0.8 MB
Reproduction Date: 2005
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Title: World Health Organization : Technical Report Series, No. 932 - in English: World Health Organization Technical Report Series ; World Health Organization Expert Committee on Biological Standardization, No. 932  
Author: World Health Organization
Volume:
Language: English
Subject: Health., Public health, Wellness programs
Collections: Medical Library Collection, World Health Collection
Historic
Publication Date:
Publisher: World Health Organization

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Organization, W. H. (n.d.). World Health Organization : Technical Report Series, No. 932 - in English. Retrieved from http://ebook2.worldlibrary.net/


Description
Medical Reference Publication

Excerpt
The WHO Expert Committee on Biological Standardization met in Geneva from 15 to 18 November 2004. The meeting was opened on behalf of the Director-General by Mrs J. Phumaphi, Assistant Director-General. Mrs Phumaphi emphasized the importance of the work of the Committee in preparing recommendations to assure safe and efficacious biological products and in establishing standard preparations important for global health. Fully functional national regulatory authorities that refer to WHO recommendations, norms and standards are essential to protect patients and improve global public health. She recalled that the Expert Committee on Biological Standardization, which had started its work as early as 1947, was one of the longest-standing WHO Committees. The Committee has been faced with the challenge of technological advancements while maintaining the highest possible standards for the quality, safety and efficacy of vaccines, biological therapeutics, blood products and selected in vitro diagnostic devices. The wide range of WHO biological reference standards improves the comparability of data in diverse fields of medical practice. Mrs Phumaphi encouraged the members to actively engage in the biological standardization work needed in their respective countries. The expertise and the experience of the participants represent an important resource that would be crucial to countries, for example in ensuring their preparedness to react to the threat of avian flu where expert guidance would facilitate the rapid availability of new vaccines as needed. She reminded the Committee of the immense contribution it had made recently, such as in the case of diagnosis of hepatitis B, which is still a threatening disease in parts of the world; some 2 billion people have been infected globally and, of these, about 360 million are believed to be chronically infected. The availability of new international reference materials for hepatitis B is a critical step in the development of appropriate standards needed for countries that lack direct access to ready-to-use reagents to evaluate diagnostics. Mrs Phumaphi emphasized the importance of promoting good manufacturing practices (GMP) for blood and blood products and pointed out that the implementation of GMP represents a very effective tool for assuring the safety and quality of all biological products. Mrs Phumaphi underlined the continued rapid developments in the field of biologicals represented by a proposal at this meeting to establish the first international standard for a human genetic test. The application of molecular genomics to medical problems presents great opportunities but also considerable challenges.

Table of Contents
Contents Introduction 1 General 2 Developments in biological standardization: WHO programmatic issues 2 Developments in biological standardization: vaccines and other biologicals 4 Developments in biological standardization: blood products and related in vitro diagnostics 6 Developments in biological standardization: advancement of technical expertise of regulatory authorities in the area of blood products and in vitro diagnostics 7 Developments in biological standardization: new web site for dissemination of information from Quality Assurance and Safety of Plasma Derivatives and Related Substances 8 Developments in biological standardization: reports from the WHO International Laboratories 9 Feedback from users: issues highlighted by the WHO Global Training Network and by the WHO prequalification process for vaccines 11 International guidelines, recommendations and other matters related to the manufacture and quality control of biologicals 12 Guidelines for production and quality control of candidate tetravalent dengue virus vaccine (live) 12 Recommendations for the preparation, characterization and establishment of international and other biological reference standards 14 Recommendations for the production and control of rabies vaccines — proposed revision 15 Recommendations for the production and quality control of diphtheria, pertussis and tetanus vaccines — proposed revision 18 Guidelines for the safe production of poliomyelitis vaccines from attenuated Sabin strains — proposal 19 Recommendations, guidelines and other documents for biological substances used in medicine: review of the consolidated list 20 Quality, safety and efficacy of antivenom sera 22 Good manufacturing practices for blood establishments: progress report on training activities 23 International Reference Materials 24 Comparison of glass ampoules versus rubber-stoppered vials for the storage of international biological standards 24 Priorities for replacement and new international biological reference standards for biologicals 25 Proposed disestablishment of the International Reference Reagent for hepatitis B vaccine 27

 

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