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Public Consultation for the WHO Expert Committee on Biological Standardization (ECBS)

 

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Published in the September 2014 issue of Biologicals

Adventitious agents in viral vaccines: Lessons learned from 4 case studies

Since the earliest days of biological product manufacture, there have been a number of instances where
laboratory studies provided evidence for the presence of adventitious agents in a marketed product.
Lessons learned from such events can be used to strengthen regulatory preparedness for the future.

Four case studies where an adventitious agent, or a signal suggesting the presence of an agent, was found in a viral vaccine, are presented in this paper. The lessons learned from each event are discussed.

Based in part on those experiences,certain scientific principles have been identified by WHO that should be considered in regulatory risk evaluation if an adventitious agent is found in a marketed vaccine in the future.

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Invitation to Join Brighton Collaboration

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file icon Rebecca Sheets 2015Tooltip 02/09/2015 Hits: 429
file icon Prof. Takao Hayakawa 2015Tooltip 02/09/2015 Hits: 347
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file icon Joris Vandeputte 2015Tooltip 02/09/2015 Hits: 744
file icon John Petricciani 2015Tooltip 02/09/2015 Hits: 364
file icon Johan VanhemelrijckTooltip 07/04/2014 Hits: 2014
file icon Jean-Marie PréaudTooltip 07/04/2014 Hits: 2137
file icon IABS Tokyo 2015 AgendaTooltip 01/09/2015 Hits: 530
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A few words from the President

 

As we start the new year, I’d like to review our 2014 accomplishments and hi-lite what we have planned for 2015.

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Veterinary Scientific Committee

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

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