The Electronic Common Technical Document (eCTD) - Building Comprehensive Functionality for Effective Implementation

The guidance on marketing applications for drugs and biologics, known as the Common Technical Document (CTD), was finalized by the International Conference on Harmonization (ICH) in 2003. Today the CTD format is highly recommended for marketing applications in the United States, and is mandatory in other regions, including Canada, Japan, and Europe.

The eCTD format has become mandatory in key markets for electronic submissions. Since January 2010, the European Medicines Agency has required all applications in the centralized procedure use the eCTD format. Since January 2008, FDA CDER has required all electronic submissions be in the eCTD format. FDA CBER requires the eCTD format for priority review and rolling submissions.

This course is designed as a review of current regulatory guidelines and how they affect strategies in the development, preparation, and successful submission of eCTDs. The foundation of the CTD’s organization, structure, and granularity are explained, along with their applicability on templates and submission-ready sections and reports. The program also explores modularity of submission components, and their applicability to lifecycle management for multi-region submissions.

Through presentations, interactive discussions, and review of real-life scenarios, the program covers the practical elements of building eCTDs, from structural and technical requirements to procedural and tactical planning that have been put into practice on successful applications. Technical elements, such as data formats, checksum function, validation criteria, and metadata requirements, are covered from an end-user perspective, with their practical implications clearly explained. In addition, participants will gain insight on assessing tools used in the preparation and completion of electronic submissions.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

Joel Alvarez is Director of Global Regulatory Operations and Technology at Shire Human Genetic Therapies Inc. Joel has global oversight for submissions and application support activities, and leads development and marketing submissions management for the ICH region and over 40 other countries worldwide. He has developed strategies and procedures for production and maintenance of electronic filings and global dossiers, including several simultaneous new marketing applications.

With over 15 years of global regulatory submissions, electronic documentation, and content management experience, Joel has played an active role in the industry-wide transition from paper to electronic submissions. Prior to joining Shire, Joel had held leadership positions at other leading bio-pharmaceutical companies, including Millennium Pharmaceuticals and Wyeth.

Joel holds a Bachelor of Science in Information Systems from So. New Hampshire University, and is a candidate for a Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University.