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.
REGISTRATION NOW OPEN
Statistical and Data Management Approaches for Biotechnology Drug Development
Co-organized by IABS and FDA
US Pharmacopeia (USP) Conference Center,
This meeting is to bring together regulators, and scientists, or those interested in statistics from academia and industry, who have a background in statistics, to help resolve existing challenges in ensuring the quality of biotechnology medicinal products and to bring high quality medicines to patients. Guidance on how to use statistics for a variety of activities required during biotechnology product development such as method development, improvement and replacement, product comparability, biosimilarity exercises and stability program development will be provided by the speakers and panel members. In addition, the complexity of the types of data and the volume being analysed is ever increasing and how best to manage such data will be discussed. The meeting will bring the right experts together to discuss the issues and through roundtables attempt to reach conclusions that will be valuable globally to public health.
Among the challenges that will be explored :
REGISTRATION NOW OPEN
Human Challenge Trials in Vaccine Development: Scientific and Regulatory Issues
September 29 – October 1, 2014
European Directorate for the Quality of Medicines & Healthcare (EDQM)
Human challenge trials can help overcome some of the hurdles inherent in vaccine development as the results obtained in these studies have more relevance than those obtained in animal models. Nevertheless, human challenge studies also face a series of scientific, ethical and regulatory issues related to the design, the execution and the use of these studies. The volunteers, healthy adults, may not represent the final target population of the vaccine, in terms of age, status of immunity and environment. The microbial strains used for challenge may behave differently from the wild pathogens. Experiments that induce infections in healthy volunteers give rise to significant ethical and regulatory issues.
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.
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.A. (Manhattan, Kansas); Morozov I.A. (Manhattan, Kansas)
Please use this link to order the book: http://www.karger.com/Book/Home/259868