Nov. 25, 2009
UI College of Pharmacy to lead development of FDA reviewer training
The University of Iowa College of Pharmacy will work with several other universities to help ensure that U.S. Food and Drug Administration (FDA) reviewers learn the latest about pharmaceutical development and technology, with the goal of improving drug product quality.
The college is a part of a national consortium that has received a two-year, $652,000 FDA contract to develop an educational program for staff in the FDA Office of Pharmaceutical Science. The consortium -- the National Institute for Pharmaceutical Technology and Education -- represents 11 universities that are known for pharmaceutical science and engineering.
The UI will be the lead for the project, which is expected to be completed by September 2011 and will involve various faculty members from the UI College of Pharmacy as well as the UI College of Engineering.
The program aims to greatly enhance the scientific training of FDA reviewers by equipping them to apply new manufacturing concepts to the practical issues associated with FDA drug review, research and policy-making activities, said the project manager Lee Kirsch, Ph.D., UI associate professor of pharmaceutics and therapeutics and faculty member of the institute.
"As educators, we are very pleased to have this opportunity to work with the FDA. We believe that this project will help facilitate the incorporation of advanced technologies into pharmaceutical manufacturing and could ultimately lead to shorter timeframes for the development of new drug products," Kirsch said.
In fall 2008, the institute received a $1.2 million FDA contact for the UI to lead a project on advancing guidelines related to how drugs are made. Read more about that project at http://www.news-releases.uiowa.edu/2008/November/110408fda_contract.html.
In addition to the UI, members of the institute include Duquesne University, Illinois Institute of Technology, Purdue University, Rutgers University, University of Puerto Rico, University of Connecticut, University of Kansas, University of Kentucky, University of Maryland-Baltimore and the University of Minnesota. Learn more about institute at http://www.nipte.org.
NOTE TO EDITORS: This news release was based on a news release by the National Institute for Pharmaceutical Technology and Education.
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