Determining Release and Throughout-Dating Potency
Specifications: A US Regulatory Policy Workshop

April 21-22, 2015
ISU Alumni Center
420 Beach Ave
Ames, Iowa USA

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Assuring the potency of each veterinary biologic product throughout its designated dating period is a key topic of regulatory policy. In this Workshop, manufacturers, regulatory authorities, and vaccine users will present perspectives and exchange information on regulatory approaches to assuring that potency, safety and efficacy expectations are met throughout the dating period. Additional context will be shared regarding international markets and human biologics. The workshop is part of the continued exchange of information necessary for policy development. One expected outcome is a white paper that will be based on published literature and the science and policy issues presented at this meeting. It will be a non-binding document provided to the USDA Center for Veterinary Biologics to inform policy on vaccine potency specifications.

 

Meeting Information

Agenda

PDF versions of Presentations

Iowa State University Alumni Center
Parking - available on the east side of the ISU Alumni Center (in the Iowa State Center Complex between Stephens Auditorium and Jack Trice Stadium)