Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements)and Communicating with the FDA
June 18 - 19, 2012 - Los Angeles PA US
Center for Professional Innovation and Education, Inc.
Phone: (610) 688-1708
This course will give participants the background and history of the Food and Drug Administration (FDA) as a basis for the strategic planning of submitting INDs, NDAs, BLAs, ANDAs, and post-approval supplements. Additionally, course content will include preparing for FDA meetings and discuss all the nuances of pharmaceutical industry interaction with the FDA. Chemistry Manufacturing and Controls (CMC), non-clinical and clinical areas will be covered. The Common Technical Document (CTD) formatting will also be discussed.