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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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May 01, 2013 |
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Center for Professional Innovation & Education, Inc., King of Prussia, PA
Oct. 21 & 22, 2013
This course will give participants the necessary overview of the US Food and Drug Administration's (FDA) current responsibilities, procedures, guidances and regulatory pathways that affect the review and approval of chemical drugs, biologics, biopharmaceuticals and generics. Using the ICH Common Technical Document (CTD) module format outline, significant Chemistry Manufacturing and Controls (CMC), Nonclinical and Clinical areas will be analyzed and discussed, as a basis for strategic planning for both submitting INDs, NDAs, BLAs, ANDAs, and post-approval supplements, as well as for holding key meetings with the FDA.
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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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