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Event

Preparing the CMC Section for NDAs/INDs/CTDs

March 15, 2012, March 16, 2012 iCal


Location: Los Angeles, CA

Course Description:

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).

For more information please visit: http://www.cfpie.com/showitem.aspx?productid=061&source=lsam
 

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