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    Archived pages: 236 . Archive date: 2014-09.

  • Title: International Alliance for Biological Standardization
    Descriptive info: .. International Alliance for Biological Standardization.. News.. Contact.. Upcoming IABS conferences.. Log in.. Main Menu.. Home.. About IABS.. Conferences.. Join IABS.. Publications.. Members' section.. Just Published in the September 2014 issue of Biologicals.. Adventitious agents in viral vaccines: Lessons learned from 4 case studies.. Since the earliest days of biological product manufacture, there have been a number of instances where.. laboratory studies provided evidence for the presence of adventitious agents in a marketed product.. Lessons learned from such events can be used to strengthen regulatory preparedness for the future.. Four case studies where an adventitious agent, or a signal suggesting the presence of an agent, was found in a viral vaccine, are presented in this paper.. The lessons learned from each event are discussed.. Based in part on those experiences,certain scientific principles have been identified by WHO that should be considered in regulatory risk evaluation if an adventitious agent is found in a marketed vaccine in the future.. Read more.. Invitation to Join Brighton Collaboration.. Career opportunities.. Latest.. The International Alliance for Biological Standardization (IABS), located in Geneva, Switzerland, is a non-profit association recognized as an NGO by WHO.. The mission of IABS is to contribute to the scientific and medical advancement of biologicals by facilitating the communication among those who develop, produce and regulate biological products for human and animal health.. IABS launches its European affiliate: IABS-EU.. This is a landmark event in the history of IABS and will open the way for greater participation with EU partners in scientific activities.. The objective of the Association IABS-EU is to support the mission and projects of the International Alliance for Biological Standardization and to enhance its image and develop its outreach within the European Union.. The Association will contribute to scientific and medical advancement of biologicals, by facilitating communication among those who develop, produce and regulate biological products for human and animal health.. More specifically, it will focus on issues concerning the regulation and standardization of biological products that are intended for market use.. A unique feature of IABS is that it acts as a neutral meeting point for the major stakeholders - regulators, academia, and industry- to consider the impact of regulatory requirements on innovation, with the objective of identifying sections that may require modification.. IABS-EU is officially recognized by French authorities as a nonprofit organization.. You will be hearing more about IABS-EU in the months ahead.. Founding Members :.. President:.. Joris Vandeputte.. Vice-president:.. Carmen Jungback.. Secretary:.. Daniel Gaudry.. Treasurer:.. Jean-Marie Préaud..  ...   workshop is expected to provide guidance on the best use of challenge trials for the definition of potential correlates of protection and for preliminary efficacy evaluation of investigational vaccines.. View the Agenda.. REGISTER HERE.. WHO Request for Comments.. Based on WHO consultations with regulators, manufacturers and other experts the following documents were prepared and have been posted on the WHO biologicals web site.. http://www.. who.. int/biologicals/en/.. for public comments:.. BS 2232 - Regulatory Risk Evaluation on Finding an Adventitious Agent in a Marketed Vaccine.. int/biologicals/BS2232_WHO_AAs_for_BS_18_June_2014.. pdf?ua=1.. Comment form.. Comments should be sent to the Responsible Officer: Dr Hye-Na Kang at email:.. kangh@who.. int.. DEADLINE: 22 September 2014.. BS 2233 – Recommendation to Assure the Quality, Safety and Efficacy of Poliomyelitis Vaccine (inactivated).. int/biologicals/IPV_FINAL_for_BS2233_07072014(2).. Comments should be sent to the Responsible Officer: Dr TieQun Zhou at email:.. zhout@who.. BS 2238 – Guidelines for procedures and data requirements for changes to approved vaccines.. int/biologicals/bs_2238_changes_to_approved_vaccines.. Comments should be sent to the Responsible Officer: Dr Dianliang Lei at email:.. leid@who.. DEADLINE: 30 September 2014.. All comments received by published deadlines will be considered in the preparation of the discussion at the ECBS meeting on 13-17 October 2014.. WHO - ECBS documents posted on WHO biologicals web site.. The following documents, adopted by the WHO ECBS in October 2013, were posted on WHO biologicals web site (.. http://who.. int/biologicals/vaccines/en/.. (on the right hand side, under New Publications), last week:.. 1.. Guidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines.. 2.. Guidelines on the quality, safety and efficacy of typhoid conjugate vaccines.. 3.. Guidelines on the quality, safety, and efficacy of biotherapeutic protein products prepared by recombinant DNA technology, Replacement of Annex 3 of WHO Technical Report Series, No.. 814.. A few words from the President.. We are now half-way through 2014, and much has happened during these first 6 months.. Read more.. Veterinary Scientific Committee.. Read more about.. Alternatives to Antibiotics, Challenges and Solutions in Animal Production.. Now available !.. Vaccines and Diagnostics for Transboundary Animal Diseases.. International Symposium, Ames, Iowa, September 2012: Proceedings.. Editor(s): Roth J.. A.. (Ames, Iowa) ; Richt J.. (Manhattan, Kansas); Morozov I.. (Manhattan, Kansas).. Please use this link to order the book:.. karger.. com/Book/Home/259868.. IABS has signed an MoU with the following organizations:.. Fondation Mérieux.. Brighton Collaboration.. Biologicals.. Table of Contents for Current Issue.. Download Biologicals Subscription Form.. Search.. Who's Online.. We have 140 guests online.. Feed Entries.. Valid.. XHTML.. and.. CSS.. International Alliance for Biological Standardization, Coordinated by.. Dodet Bioscience..

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  • Title: International Alliance for Biological Standardization
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  • Title: News
    Descriptive info: ( 2 Articles ).. General.. ( 3 Articles ).. Home page news..

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  • Title: IABS
    Descriptive info: IABS.. Mailing Office Address.. IABS, Route des Jeunes 9.. Carouge-Geneva.. CH-1227.. Switzerland.. This e-mail address is being protected from spambots.. You need JavaScript enabled to view it.. + 41 22 301 10 36.. + 41 22 301 10 37..

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  • Title: Upcoming IABS conferences
    Descriptive info: 20-22 April, 2015 - The Netherlands.. The Consistency Approach and Alternative Methods: Towards Non-Animal based testing in vaccine development and QC.. Date:.. April 20-22, 2015.. Venue:.. Hotel Zuiderduin.. Egmond aan Zee.. The Netherlands.. 29 September - 1 October, 2014 - Strasbourg, France.. REGISTRATION NOW OPEN.. :.. 29 September - October 1, 2014.. View the Provisional Agenda.. REGISTER HERE..

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  • Title: Login
    Descriptive info: Login.. Members' section.. Welcome to the members' section.. Please log in.. Username.. Password.. Remember Me.. Forgot your Password?.. Forgot your Username?..

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  • Title: About IABS
    Descriptive info: Who We Are.. Conflict of Interest.. Constitution.. About IABS.. The International Alliance for Biological Standardization (IABS) is an independent, non-profit scientific Alliance, governed by Articles 60-79 of the Swiss Civil code and by its.. Its office is located in Geneva (Switzerland).. IABS has about 250 members in over 50 countries.. Mission.. IABS is devoted to the scientific and medical advancement of biologicals, by facilitating communication among those who develop, produce and regulate biological products for human and animal health.. Objectives.. To provide a unique platform for discussion and the development of consensus positions on contemporary issues related to biologicals;.. To create an ongoing interface among leaders in clinical  ...   for biological substances used in human and veterinary medicine, through its conferences and publications;.. To promote uniform methods for establishing the international quality of biological products;.. To encourage research in connection with the characterization, standardization, quality, production, and clinical use of biological products.. History.. IABS was founded in Lyon, France, in 1955 by a group of independent experts who believed that such an organization could provide a forum where data could be discussed among scientists working in research, development, production, standardization and regulation of human and veterinary biological products with the ultimate aim of using sound scientific data to improve the quality of biological products and their regulation..

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  • Title: Upcoming IABS conferences
    Descriptive info: IABS Conferences.. Other conferences..

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  • Title: Become a Member of IABS
    Descriptive info: Become a Member of IABS.. Individuals.. IABS is an independent, nonprofit organization dedicated to the scientific and medical advancement of biologicals in human and animal health by facilitating communication at an international level among academia, regulatory authorities and industry.. Our members work in the field of biologicals as professionals in universities, foundations, corporations, and international organizations around the world.. By joining IABS, you will broaden your knowledge of therapeutic biologicals as well as vaccines, and have the opportunity to network and exchange ideas during IABS conferences and symposia with experts in the field.. Benefits of Membership.. As an Individual Member of IABS, you will:.. Join a community of recognized experts.. Share thoughts, ideas and suggestions on IABS meetings, activities  ...   is CHF 90 / EUR 75.. 00 / USD 96.. 00.. The annual membership fee for students and individuals in developing countries is 10 Swiss Francs.. Membership Application for Individuals.. Organizations.. Organizations that are involved in the field of biologicals such as scientific societies, industry, and governmental institutions should consider joining IABS to work with others on helping to identify and resolve emerging regulatory issues.. An official representative of a member organization may participate in IABS conference activities and be elected to the Board in the same manner as an individual member.. There is no membership fee for organizations.. Membership Application for Organizations.. General Conditions of Sale.. For more information, please contact the Alliance at the following address:.. iabs@iabs.. org..

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  • Title: Publications
    Descriptive info: Publications.. IABS publications.. To fulfil its mission of promoting dissemination of knowledge, IABS publishes:.. Original articles, reviews and meeting reports in the Association's journal,.. , an international journal published by Elsevier (London);.. provides a modern and multidisciplinary international forum for news, debate, and original research on all aspects of biologicals used in human and veterinary medicine.. The journal publishes original papers (research reports), short papers, review articles,  ...   standardization of biological products derived from both novel and established biotechnologies.. Special issues are produced to reflect topics of particular international interest and concern.. Editor-in-chief: Dr.. Girish Vyas (USA).. Guidance for Authors.. Proceedings of conferences in the symposium series.. Developments in Biologicals.. published by.. Karger.. (Basel).. 135 volumes of the series have been published to date.. Volume 135.. is available both as a soft-cover book and online..

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  • Title: Login
    Descriptive info: Welcome to the Members' Section.. Please login..

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  • Archived pages: 236