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U.S. Department of Health and Human Services

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CDER Small Business Webinar on Building Quality into Clinical Trials – an FDA Perspective – May 14, 2012

The Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Small Business Assistance Program is pleased to inform you of a unique opportunity for small business entities to learn more about the FDA and basic drug regulation. Our webinar series highlights various aspects of drug regulation.

These focused webinars support the Program’s mission of promoting productive interaction with regulated industry by assisting regulated domestic and international small pharmaceutical business with information relating to the development and regulation of human drug products.

On Monday May 14, 2012, we presented our webinar entitled Building Quality into Clinical Trials – an FDA Perspective which discussed the elements of a quality system, how they are related to FDA regulations and suggestions for a quality study.

Our presenter was biophysicist, Dr. Jean Toth-Allen, who is presently a member of the Office of Good Clinical Practice (OGCP), in the Office of Special Medical Programs (OSMP) in the Office of the FDA Commissioner.  Previous to joining OGCP, she was a bioresearch monitoring (BIMO) reviewer in the Division of Bioresearch Monitoring (DBM) in the Center for Devices and Radiological Health (CDRH).   

Dr. Toth-Allen serves as an OGCP device expert while working on human subject protection and good clinical practice issues related to all FDA-regulated products.  As part of OGCP’s broader role in the coordination of the agency’s BIMO program, she is also the project manager for the Good Laboratory Practices (GLP) Working Group (WG), which is tasked with the development of any regulatory modification and/or guidance the WG determines is needed in this area.  She also continues to be active in the agency’s outreach programs.   

Before joining FDA in 1994, as a member of the training branch in the Division of Mammography Quality and Radiation Programs, she taught at George Mason University, Fairfax, VA, where she held a joint appointment in both the biology and physics departments.  She received both her M.S. and Ph.D. in Biophysics from Michigan State University.  

For More Information:

http://www.fda.gov/smallbusinessdrugs

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