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Preparing the CMC Section for NDAs/INDs/CTDs
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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.

6/3/2015 to 6/4/2015
When: June 3-4, 2015
9:00 a.m. - 5:00 p.m.
Where: The Desmond Hotel and Conference Center
1 Liberty Blvd
Malvern, Pennsylvania  19355
United States
Presenter: The Center for Professional Innovation & Education, Inc.
Contact: Olivia Carlin
610.648.7550

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Preparing the CMC Section for NDAs/INDs/CTDs

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).

 

Learn more about the course and register.

CfPIE is a preferred provider and offers MichBio members a 15% discount on course registration fees. Click here for more information.

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