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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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October 16, 2012 |
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Center for Professional Innovation & Education, Inc., Los Angeles, CA
Mar 14 & 15, 2013
This course includes an overview of the International Conference on Harmonization (ICH) process and the organization of the CTD, detailed information and discussions related to each element required in the drug substance and drug product sections of NDAs and INDs. The course will emphasize the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities, stability, and pharmaceutical development reports. It will also discuss the use of Drug Master Files (DMF) and preparation of the CTD Quality Overall Summary (Module 2).
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Organized by:
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Center for Professional Innovation & Education, Inc. |
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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=061&source=hummolgen
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E-mail:
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info@cfpie.com
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