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.
REGISTER FOR THE WORKSHOP
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 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
Comments should be sent to the Responsible Officer: Dr Hye-Na Kang at email: firstname.lastname@example.org
DEADLINE: 22 September 2014
BS 2233 – Recommendation to Assure the Quality, Safety and Efficacy of Poliomyelitis Vaccine (inactivated)
Comments should be sent to the Responsible Officer: Dr TieQun Zhou at email: email@example.com
DEADLINE: 22 September 2014
BS 2238 – Guidelines for procedures and data requirements for changes to approved vaccines
Comments should be sent to the Responsible Officer: Dr Dianliang Lei at email: firstname.lastname@example.org
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.