Who Expert Committee On Biological Standardization

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Who Expert Committee On Biological Standardization
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Author : World Health Organization. Expert Committee on Biological Standardization
language : en
Publisher: World Health Organization
Release Date : 2015-06-30
Who Expert Committee On Biological Standardization written by World Health Organization. Expert Committee on Biological Standardization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-06-30 with Business & Economics categories.
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 a WHO guidance document on the Scientific principles for regulatory risk evaluation on finding an adventitious agent in a marketed vaccine was adopted along with WHO Guidelines on procedures and data requirements for changes to approved vaccines and revised WHO Recommendations to assure the quality safety and efficacy of poliomyelitis vaccines (inactivated). Subsequent sections of the report provide information on the current status and proposed development of international reference materials in the areas of antibiotics; biotherapeutics other than blood products; blood products and related substances; in vitro diagnostic device reagents; and vaccines and related substances. A series of annexes are then presented which include an updated list of all WHO Recommendations Guidelines and other documents on biological substances used in medicine (Annex 1). The above three WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2–4). Finally all additions and discontinuations made during the 2014 meeting to the list of International Standards Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 5. The updated full catalogue of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.
Who Expert Committee On Biological Standardization
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Author :
language : en
Publisher: World Health Organization
Release Date : 2022-04-12
Who Expert Committee On Biological Standardization written by and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-04-12 with Medical categories.
Who Expert Committee On Biological Standardization
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Author : World Health Organization. Expert Committee on Biological Standardization
language : en
Publisher:
Release Date : 1969
Who Expert Committee On Biological Standardization written by World Health Organization. Expert Committee on Biological Standardization and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1969 with Biological products categories.
Who Expert Committee On Biological Standardization
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Author : WHO Expert Committee on Biological Standardization
language : en
Publisher:
Release Date : 2013
Who Expert Committee On Biological Standardization written by WHO Expert Committee on Biological Standardization and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with Biological products categories.
Who Expert Committee On Biological Standardization
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Author : WHO Expert Committee on Biological Standardization. Meeting
language : en
Publisher: World Health Organization
Release Date : 2013
Who Expert Committee On Biological Standardization written by WHO Expert Committee on Biological Standardization. Meeting and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with Medical categories.
"The WHO Expert Committee on Biological Standardization (ECBS) met in Geneva from 18 to 22 October 2010"--Introduction.
Who Expert Committee On Biological Standardization
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Author :
language : en
Publisher:
Release Date : 2017
Who Expert Committee On Biological Standardization written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017 with Biological products categories.
Who Expert Committee On Biological Standardization
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Author : World Health Organization. Expert Committee on Biological Standardization
language : en
Publisher: World Health Organization
Release Date : 2016
Who Expert Committee On Biological Standardization written by World Health Organization. Expert Committee on Biological Standardization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016 with Medical categories.
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, a WHO guidance document on Regulatory assessment of approved rDNA-derived biotherapeutics was adopted along with WHO Guidelines on the stability evaluation of vaccines for use under extended controlled temperature conditions and on WHO good manufacturing practices for biological products. In addition, revised WHO Recommendations to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines were also adopted by the Committee. Subsequent sections of the report provide information on the current status and proposed development of international reference materials in the areas of antibiotics; biotherapeutics other than blood products; blood products and related substances; in vitro diagnostic device reagents; and vaccines and related substances. A series of annexes are then presented which include an updated list of all WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1). The above four WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2-5). Finally, all additions and discontinuations made during the 2015 meeting to the list of International Standards, Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 6. The updated full catalog of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.
Who Expert Committee On Biological Standardization
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Author : World Health Organisation Staff
language : en
Publisher:
Release Date : 1991-10
Who Expert Committee On Biological Standardization written by World Health Organisation Staff and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1991-10 with Biological products categories.
Who Expert Committee On Biological Standardization
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Author : WHO Expert Committee on Biological Standardization. Meeting
language : en
Publisher: World Health Organization
Release Date : 2005-12-14
Who Expert Committee On Biological Standardization written by WHO Expert Committee on Biological Standardization. Meeting and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-12-14 with Business & Economics categories.
The WHO Expert Committee on Biological Standardization is commissioned by WHO to establish detailed recommendations and guidelines for the manufacturing, licensing, and control of blood products, cell regulators, vaccines and related in vitro diagnostic tests. Members of the Expert Committee are scientists from national control agencies, academia, research institutes, public health bodies and the pharmaceutical industry acting as individual experts and not as representatives of their respective organizations or employers. The decisions and recommendations of the Committee are based entirely on scientific principles and considerations of public health. The Expert Committee on Biological Standardization meets on an annual basis since 1947 and is reponsible for the establishment of the WHO International Biological Reference Preparations and for the adoption of the WHO Recommendations and Guidelines. The Expert Committee directly reports to the Executive Board, which is the executive arm of the World Health Assembly.
Who Expert Committee On Biological Standardization
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Author : World Health Organization. WHO Expert Committee on Biological Standardization
language : en
Publisher:
Release Date : 2014
Who Expert Committee On Biological Standardization written by World Health Organization. WHO Expert Committee on Biological Standardization and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014 with categories.