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HEAR FROM LEADING EXPERTS
Michel Duchene, IFPMA
William Egan, PharmaNet Consulting
Suresh Jadhav, DCVMN
Teeranart Jivapaisarnpong, Department of Medical Sciences, Thailand
Ivana Knezevic, WHO
Philip Krause, FDA
Michael Pfleiderer, Paul-Ehrlich-Institut
Isabelle Pierard, IFPMA
Timothy Schofield, IFPMA
Jinho Shin, WHO
Dean Smith, Health Canada
James Southern, Advisor to Medicines Control Council, South Africa
WHO Guidelines
The WHO guidelines on stability evaluation of vaccines assist national regulatory authorities and manufacturers in the stability testing of vaccines, providing a set of general principles and descriptions of stability studies for all stages of the vaccine “life cycle”.
Contact us - IABS
International Association for Biologicals (IABS)
Web:www.iabs.org
Email: iabs@iabs.org
IABS International Scientific Workshop
STABILITY OF VACCINES, DEFINED AS THE ABILITY TO REMAIN SAFE AND EFFICACIOUS THROUGHOUT MANUFACTURE AND SHELF-LIFE, IS ESSENTIAL FOR THE SUCCESS OF IMMUNIZATION PROGRAM THROUGHOUT THE WORLD.
At its 57th meeting in October 2006, the World Health Organization Expert Committee on Biological Standardization adopted new guidelines on stability evaluation of vaccines in order to assist national vaccine regulatory authorities and manufacturers on stability testing of vaccines. These guidelines provide a set of general principles and descriptions for stability studies for all stages of the vaccine “life cycle”, including development, registration, launch, monitoring, changes and variations. Statistical approaches given in the guidance should facilitate the establishment of shelf-life, and provide efficient and effective strategies for monitoring product stability and guaranteeing comparable stability after a process change.
The International Association of Biologicals (IABS), in association with the UK National Institute for Biological Standards and Control (NIBSC), US National Institute of Allergy and Infectious Diseases (NIAID), Germany’s Paul-Ehrlich-Institut (PEI) and World Health Organization (WHO), is organizing an interactive conference to inform and assist regulators and industry in the implementation of the principles and approaches set out in the recently adopted WHO guidelines on the stability evaluation of vaccines. The conference will focus on i) elaborating basic principles and goals of vaccine stability studies, ii) methods of stability evaluation throughout the vaccine life cycle, and iii) special considerations in evaluating vaccine stability.
The conference will be held on 27-29 October 2008 in Geneva, Switzerland at the Geneva International Conference Centre (www.cicg.ch/en).