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Who Expert Committee On Biological Standardization
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Author :WHO Expert Committee on Biological Standardization. Meeting Publisher :World Health Organization ISBN 13 :9241209798 Total Pages :382 pages Book Rating :4.2/5 (412 download)
Book Synopsis Who Expert Committee on Biological Standardization by : WHO Expert Committee on Biological Standardization. Meeting
Download or read book Who Expert Committee on Biological Standardization written by WHO Expert Committee on Biological Standardization. Meeting and published by World Health Organization. This book was released on 2013 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The WHO Expert Committee on Biological Standardization (ECBS) met in Geneva from 17 to 21 October 2011"--Introduction.
Book Synopsis WHO Expert Committee on Biological Standardization by : World Health Organization
Download or read book WHO Expert Committee on Biological Standardization written by World Health Organization and published by World Health Organization. This book was released on 2015-06-30 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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/.
Author :WHO Expert Committee on Biological Standardization. Meeting Publisher :World Health Organization ISBN 13 :924120978X Total Pages :398 pages Book Rating :4.2/5 (412 download)
Book Synopsis WHO Expert Committee on Biological Standardization by : WHO Expert Committee on Biological Standardization. Meeting
Download or read book WHO Expert Committee on Biological Standardization written by WHO Expert Committee on Biological Standardization. Meeting and published by World Health Organization. This book was released on 2013 with total page 398 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The WHO Expert Committee on Biological Standardization (ECBS) met in Geneva from 18 to 22 October 2010"--Introduction.
Author :WHO Expert Committee on Biological Standardization. Meeting Publisher :World Health Organization ISBN 13 :9241209771 Total Pages :241 pages Book Rating :4.2/5 (412 download)
Book Synopsis WHO Expert Committee on Biological Standardization by : WHO Expert Committee on Biological Standardization. Meeting
Download or read book WHO Expert Committee on Biological Standardization written by WHO Expert Committee on Biological Standardization. Meeting and published by World Health Organization. This book was released on 2013 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, endocrinological substances and in vitro diagnostic devices. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains revised WHO recommendations for production and control of live attenuated influenza vaccines and for production and control of pneumococcal conjugate vaccines. New WHO guidelines on the regulatory evaluation of similar biotherapeutic medicines are also provided. Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances.
Author :WHO Expert Committee on Biological Standardization. Meeting Publisher :World Health Organization ISBN 13 :9241209410 Total Pages :353 pages Book Rating :4.2/5 (412 download)
Book Synopsis WHO Expert Committee on Biological Standardization by : WHO Expert Committee on Biological Standardization. Meeting
Download or read book WHO Expert Committee on Biological Standardization written by WHO Expert Committee on Biological Standardization. Meeting and published by World Health Organization. This book was released on 2007-12-15 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations to assure the quality safety and efficacy of vaccines blood products and other biological medicines and the establishment of international biological reference standards for these products and related diagnostic devices. The report of particular relevance to manufacturers and national regulatory authorities starts with a discussion of general issues brought to the Committee's attention. The second part of the report contains written specifications that establish international regulatory expectations for the following products; DNA vaccines pertussis (whole cell) vaccine plasma (human) for fractionation rabies vaccine and rotavirus vaccine. The report also provides a risk assessment and defines conditions for the safe production of pandemic strain influenza vaccines. The third part of the report provides information on the status and development of international reference materials for various antibodies antigens blood products and related substances and in vitro diagnostic devices.
Book Synopsis WHO Expert Committee on Biological Standardization by :
Download or read book WHO Expert Committee on Biological Standardization written by and published by World Health Organization. This book was released on 2021-03-10 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis WHO Expert Committee on Biological Standardization by :
Download or read book WHO Expert Committee on Biological Standardization written by and published by World Health Organization. This book was released on 2020-05-15 with total page 247 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 Guidelines on the quality, safety and efficacy of respiratory syncytial virus vaccines; and an Amendment document to the WHO Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated) were adopted on the recommendation of the Committee. 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; cellular and gene therapies; in vitro diagnostics; 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).
Book Synopsis WHO Expert Committee on Biological Standardization by : Comité OMS d'experts de la standardisation biologique
Download or read book WHO Expert Committee on Biological Standardization written by Comité OMS d'experts de la standardisation biologique and published by . This book was released on 2005 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis WHO Expert Committee on Biological Standardization by : World Health Organization
Download or read book WHO Expert Committee on Biological Standardization written by World Health Organization and published by World Health Organization. This book was released on 2018-07-18 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 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. 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 2017 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 catalogue of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.
Author :WHO Expert Committee on Biological Standardization. Meeting Publisher :World Health Organization ISBN 13 :9241209275 Total Pages :160 pages Book Rating :4.2/5 (412 download)
Book Synopsis WHO Expert Committee on Biological Standardization by : WHO Expert Committee on Biological Standardization. Meeting
Download or read book WHO Expert Committee on Biological Standardization written by WHO Expert Committee on Biological Standardization. Meeting and published by World Health Organization. This book was released on 2005-12-14 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis WHO Expert Committee on Biological Standardization by :
Download or read book WHO Expert Committee on Biological Standardization written by and published by World Health Organization. This book was released on 2021-05-06 with total page 291 pages. Available in PDF, EPUB and Kindle. Book excerpt: The seventy-second meeting of the WHO Expert Committee on Biological Standardization was held from 19 to 23 October 2020 by WebEx video conferencing due to the restrictions imposed during the coronavirus disease 2019 (COVID-19) pandemic. The meeting was opened on behalf of the Director-General of WHO by Dr Mariângela Batista Galvão Simão, Assistant Director-General, Access to Medicines and Health Products. Dr Simão welcomed Committee members, meeting participants and observers. Dr Simão began by noting that the Committee had met as recently as August 2020, primarily to address standardization activities related to COVID-19, and that much remains to be learnt about the pandemic. The WHO Solidarity Trial was continuing to facilitate the rapid and robust comparison of potential treatments. Recently published interim results indicated that the four small molecule treatments remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon had little or no benefit in terms of overall mortality or speed of recovery of hospitalized patients – to date only dexamethasone had proved to be effective against severe COVID-19.
Book Synopsis WHO Expert Committee on Biological Standardization by :
Download or read book WHO Expert Committee on Biological Standardization written by and published by World Health Organization. This book was released on 2022-04-12 with total page 178 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :World Health Organization. Expert Committee on Biological Standardization Publisher :World Health Organization ISBN 13 :9241209992 Total Pages :292 pages Book Rating :4.2/5 (412 download)
Book Synopsis WHO Expert Committee on Biological Standardization by : World Health Organization. Expert Committee on Biological Standardization
Download or read book WHO Expert Committee on Biological Standardization written by World Health Organization. Expert Committee on Biological Standardization and published by World Health Organization. This book was released on 2016 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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/.
Book Synopsis WHO Expert Committee on Biological Standardization by : World Health Organization
Download or read book WHO Expert Committee on Biological Standardization written by World Health Organization and published by . This book was released on 2018 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis WHO Expert Committee on Biological Standardization by : WHO Expert Committee on Biological Standardization. Meeting
Download or read book WHO Expert Committee on Biological Standardization written by WHO Expert Committee on Biological Standardization. Meeting and published by WHO. This book was released on 2004 with total page 109 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication contains the recommendations of a WHO Expert Committee, which met in Geneva in February 2003, relating to quality and standardisation of biological products. Aspects discussed include: International recommendations, guidelines and other matters related to the manufacture and quality control of biologicals; international reference standards; antibodies, antigens and related substances, blood products and related substances, cytokines, growth factors, and endocrinological substances and diagnostic reagents.
Book Synopsis WHO Expert Committee on Biological Standardization by : World Health Organisation Staff
Download or read book WHO Expert Committee on Biological Standardization written by World Health Organisation Staff and published by . This book was released on 1991-10 with total page 79 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :WHO Expert Committee on Biological Standardization. Meeting Publisher :World Health Organization ISBN 13 :9241209801 Total Pages :507 pages Book Rating :4.2/5 (412 download)
Book Synopsis WHO Expert Committee on Biological Standardization by : WHO Expert Committee on Biological Standardization. Meeting
Download or read book WHO Expert Committee on Biological Standardization written by WHO Expert Committee on Biological Standardization. Meeting and published by World Health Organization. This book was released on 2014 with total page 507 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 biologicals, 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 of revised WHO Recommendations and Guidelines for a number of vaccines, blood products and related substances. Specific discussion areas included the development of WHO guidance on the quality, safety and efficacy of poliomyelitis vaccines (oral, live, attenuated); recombinant malaria vaccines; diphtheria vaccines (adsorbed); tetanus vaccines (adsorbed); combined vaccines based on diphtheria and tetanus vaccines; and Japanese encephalitis vaccines (live, attenuated). Subsequent sections of the report then provide information on the current status and proposed development of international reference materials in the areas of vaccines and related substances; blood products and related substances; in vitro diagnostic device reagents; biotherapeutics other than blood products; and antibiotics. A series of annexes are then presented which include an updated list of WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1), followed by a series of WHO Recommendations and Guidelines adopted on the advice of the Committee (Annexes 2-7). All additions made during the meeting to the list of International Standards and Reference Reagents for biological substances maintained by WHO are then summarized in Annex 8.
