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December 8 - 10, 2008 - Costa Mesa, CA
This course is designed to identify and review applicable regulatory guidelines (U.S., EU, ICH, and other regional guidances), providing information on the content and preparation of the CTD, and will address specifications and granularity for electronic submissions (eCTD). The course discusses tips for efficient preparation of the CTD with submission-ready reports, that can be written early in development and inserted or expanded for marketing applications. The use of CTD mapping and templates to facilitate gap analysis, project management, CMC strategy, and life cycle management will also be discussed in interactive sessions. Case studies will be presented throughout the course to encourage group discussions.
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This course is designed to identify and review applicable regulatory guidelines (U.S., EU, ICH, and other regional guidances), providing information on the content and preparation of the CTD, and will address specifications and granularity for electronic submissions (eCTD). The course discusses tips for efficient preparation of the CTD with submission-ready reports, that can be written early in development and inserted or expanded for marketing applications. The use of CTD mapping and templates to facilitate gap analysis, project management, CMC strategy, and life cycle management will also be discussed in interactive sessions. Case studies will be presented throughout the course to encourage group discussions.
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