This two-day course is designed for professionals of the biotechnology and pharmaceutical industries who are currently, or planning to become, involved in the development of regulatory submissions using the electronic Common Technical Document (eCTD). Upon completion of this course, participants will be able to: Develop project plans for the compilation of compliant eCTD submissions (including proper organization and tracking); identify processes employed in preparing CTD/eCTD submissions; understand how to prepare CTD content templates and requirements to generate submission-ready documents; recognize requirements specific to electronic submissions, implications on predicate rules, and differences and similarities across regions; and identify tools and technology used in preparation and review of eCTDs.
To find more information please click here: The Electronic Common Technical Document (eCTD) - Building Comprehensive Functionality for Effective Implementation - Two-day course - Los Angeles, CA - Oct. 24 & 25, 2011
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