News

New Technologies, New Vaccine VIII

How New Science is Shaping Regulatory and Business Decision Making

 

Previously titled “New Cells, New Vaccines” the conference name has been changed to reflect the tremendous impact of new technologies on the development and manufacture of vaccines.

 

Find the Agenda Here

 

Register Here

 

2014 Annual Conference on Vaccine Research

 

The Annual Conference on Vaccine Research (ACVR) provides high-quality, current reports of scientific progress and best practices featured in both invited presentations and submitted oral abstracts and posters.

Read more

ACVR Postcard

 

Registration Now Open

 

 

IABS is proud to announce

 

Dr. Kathryn C. Zoon

is the recipient of the

2014 William S. Hancock Award

for Outstanding Achievements in CMC Regulatory Science

 

Invitation to Join Brighton Collaboration

banner-brighton-collaboration

Read more

 

Career opportunities


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.

Latest News

 

USDA-ARS Animal Influenza Viruses Gap Analysis Workshop Report March 2014

 

The USDA-ARS Animal Influenza Viruses Countermeasures Working Group (AICWG) met in Athens, Georgia, March 25-27, 2013, to assess the scientific information and countermeasures available to effectively control and mitigate the impact of an outbreak of an animal influenza virus that is highly pathogenic and/or with zoonotic or pandemic potential.

View the Workshop Report

 

REGISTRATION NOW OPEN

 
 

Statistical and Data Management Approaches for Biotechnology Drug Development

 

Co-organized by IABS and FDA

 

Date:

August 27-28

Venue:

US Pharmacopeia (USP) Conference Center,

Rockville, Maryland

 

 

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 :

 

  • Statistical Challenges with showing Comparability and Biosimilarity (Equivalence, small data sets, tolerance intervals etc.)

 

  • Using statistics for Assay Methods (Statistics for development, qualification, validation and transfer of methods)

 

  • The use of statistics and modelling when using Quality by Design (DoE, Bayesian, partial least squares, prior knowledge data sets)

 

  • Managing large and/or complex datasets (Large data sets for monitoring variation, complex analytical methods – Mass Spec, NMR, historical data sets)

 

 

REGISTER HERE

 

View the Agenda

 

REGISTRATION NOW OPEN

 

 

 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)

Strasbourg, France

 

 

 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.

This IABS workshop will bring together representatives from academia, industry, regulatory and public health agencies to discuss the scientific, ethical and regulatory framework required for safe and ethical conduct of challenge trials. In addition, the 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 Provisional Agenda

REGISTER HERE

 

 

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

 

A few words from the President

IABS has an ambitious agenda for 2014 both in terms of conferences that we are sponsoring and co-sponsoring, as well as initiatives that we are taking to strengthen our working relationships with other organizations with an interest in biologicals.  You will be hearing more about this in the months ahead. In the meantime, I look forward to working with you, our committees, the scientific secretariat and the Board to achieve our goals.

With best regards,

John Petricciani, MD

Veterinary Scientific Committee

Read more about Alternatives to Antibiotics, Challenges and Solutions in Animal Production

Read more

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

IABS has signed an MoU with the following organizations:

Fondation Mérieux

Brighton Collaboration

Search

Who's Online

We have 319 guests online
International Alliance for Biological Standardization, Coordinated by Dodet Bioscience