CMC Workshop: Translating Science into Successful Regulatory Submissions

Venue: Washington Hilton Hotel

Location: Washington, Washington DC, United States

Event Date/Time: Feb 07, 2011 End Date/Time: Feb 09, 2011
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Co-sponsored by the American Association of Pharmaceutical Scientists.

Discuss Challenging Topics Facing the Pharmaceutical and Biopharmaceutical Communities from Development, Implementation, and Regulatory Submissions Perspectives.
This CMC workshop will feature cross-functional discussions on science and risk-based approaches to drug development and manufacturing, drug substance and drug product specifications, genotox impurities, global stability studies, and post-approval changes.

This program has been developed by the CMC Working Group of the DIA Regulatory Affairs Special Interest Area Community.

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