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.
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Challenges Toward Sound Scientific Regulation of Cell Therapy Products
Co-sponsored by Japan Science and Technology Agency (JST)
Date: March 7-8, 2014
Venue: Kyoto International Conference Center
This meeting will bring together an outstanding and diverse group of speakers, from regulatory agencies, industry, academia, all of whom are at the forefront of the cell therapy field. The meeting intends to increase awareness of the diverse views of our global partners, as well as to promote international dialogue and exchange of information and points of view in this evolving field. The starting point will be to share a common recognition of the essential scientific elements for early product development, evaluation and control of cell therapy products. Then we will move on to identify very critical points/issues to be solved, improved, and/or developed in terms of technical as well as scientific regulation in order to facilitate the availability of products in a rational and timely manner, which will be valuable globally to public health.
Statistical and Data Management Approaches for Biotechnology Drug Development
Co-organized by IABS and FDA
Date: August 27-28
Venue: USP Headquarters, Rockville
This meeting is to bring together regulators, and scientists, from academia and industry, who are career statisticians or have a strong 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 :
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Human Challenge Trials in Vaccine Development: Scientific and Regulatory Issues
Date: September 29 – October 1, 2014
Venue: 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