Who Should Attend
This 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). The program is particularly suitable for project team members interested in gaining a practical understanding of regulations, tools, and required submission processes. This includes professionals working in:
- Regulatory Affairs / Regulatory Operations
- Submissions Management
- Authors of CTD Sections
- Technical and Clinical Writers
- Documentation Teams
- Project Management
- Information Technology and Information Systems
Learning Objectives
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
- Identify tools and technology used in preparation and review of eCTDs
Participants will also learn tips on assembling global CTD dossiers, working on classic and virtual submission teams, and proper resource planning.
Course Description
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.