CMC Workshop: Translating Science into Successful Regulatory Submissions
Venue: Washington Hilton Hotel
|Event Date/Time: Feb 07, 2011||End Date/Time: Feb 09, 2011|
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.