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Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements)and Communicating with the FDA

  January 06, 2012  
Center for Professional Innovation & Education (CfPIE), Los Angeles, CA
June 18 & 19, 2012

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.
Organized by: Center for Professional Innovation & Education
Invited Speakers: Contact info@cfpie.com for a list of course instructors
Deadline for Abstracts: n/a
Registration: http://www.cfpie.com/showitem.aspx?productid=085&source=hummolgen
E-mail: info@cfpie.com
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