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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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August 30, 2011 |
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Center for Professional Innovation & Education (CfPIE), Berlin, Germany
Oct. 27 & 28, 2011
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.
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Organized by:
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Center for Professional Innovation & Education |
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Invited Speakers:
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Contact info@cfpie.com for a list of course instructors
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Deadline for Abstracts:
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n/a
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Registration:
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http://www.cfpie.com/showitem.aspx?productid=085&source=hummolgen
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E-mail:
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info@cfpie.com
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