NIPTE to develop educational programs on leading edge pharmaceutical technology for FDA reviewers

The U.S. Food and Drug Administration (FDA) has awarded the National Institute for Pharmaceutical Technology and Education, Inc. (NIPTE) a $652,000 two-year contract to develop and deliver a professional development program to help to ensure that FDA reviewers are current in state-of-the-art pharmaceutical manufacturing and technology.

The implementation of this contract 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 Science (OPS) staff that review and evaluate the quality information for new drug applications. The program will increase the ability of reviewers to apply the 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 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 the project manager on this contract.

In the initial period, NIPTE will work with the OPS on identifying the needs and developing recommendations on training areas. Once the assessment is complete, NIPTE will develop and deliver a scientific training program for the designated OPS staff. “NIPTE has two interconnected goals which are advancing research and education. This project fits very well with our mission,” said Prabir Basu, executive director of NIPTE.

The program will begin this year and is expected to be completed by September 2011.