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November 30, 2009
NIPTE awarded FDA contract to develop educational program in pharmaceutical manufacturing science for agency reviewers
WEST LAFAYETTE, Ind. - The U.S. Food and Drug Administration has awarded the National Institute for Pharmaceutical Technology and Education a $652,000 two-year contract to develop and deliver a program to ensure FDA reviewers are current in state-of-the-art pharmaceutical manufacturing and technology.The contract's implementation will require the design, development, delivery and assessment of a well-structured educational program based on the needs of the FDA's Office of Pharmaceutical Sciences staff that review and evaluate information for new drug applications. The program will increase the ability of reviewers to apply newly acquired knowledge to practical issues associated with the review, research and policy-making activities.
"As educators we are very pleased to have this opportunity to work with the FDA. We believe that this project will help to facilitate the incorporation of advanced technologies into pharmaceutical manufacturing," said Lee Kirsch, professor of pharmaceutics at the University of Iowa and NIPTE faculty member who will serve as project manager on the contract.
In the initial period, the NIPTE will work with the FDA to identify the needs and develop recommendations on training areas. Once the assessment is completed, NIPTE will develop and deliver a scientific training program for the FDA's Office of Pharmaceutical Sciences staff.
"NIPTE has two interconnected goals that are advancing both research and education. This project fits very well with our mission," said Prabir Basu, the institute's executive director.
The program will begin this year and is expected to be completed by next September.
ABOUT NIPTE
The National Institute of Pharmaceutical Technology and Education, known as NIPTE, is an independent, non-profit organization representing 11 U.S. universities that are leaders in pharmaceutical science and engineering. Member universities are Duquesne University, Illinois Institute of Technology, Purdue University, Rutgers University, University of Puerto Rico, University of Connecticut, University of Iowa, University of Kansas, University of Kentucky, University of Maryland-Baltimore, and the University of Minnesota. The institute's offices are based in Purdue's Discovery Park.
Writer: Phillip Fiorini, 765-496-3133, pfiorini@purdue.edu
Sources: Prabir Basu, 765-494-9614, pbasu@nipte.org, prabir1960@purdue.edu
Lee Kirsch, 319-335-8824, lee-kirsch@uiowa.edu
Purdue News Service: (765) 494-2096; purduenews@purdue.edu
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