Pharma / Biotech
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. In the US, the eCTD format has become a requirement for all New Drug Applications, Biologics License Applications and Abbreviated New Drug Applications following the 2012 reauthorization/update of the Prescription Drug User Fee Act (PDUFA). Further, the Generic Drug User Fee Act and Medical Device User Fee Act also impose mandatory electronic submissions to FDA.
This course, while focusing on the US requirements, also provides a quick overview of current regulatory guidelines of eCTD in major world market including North America, the European Union, and Asia-Pacific. It aims to introduce tools to assist the participants in formulating effective strategies in the development, compilation, and submission of US-compliant eCTDs. The structure of the eCTD, its content and granularity for the modules will be introduced, along with a review of the specifications, scope, requirements for the architecture and functionalities, as well as its impact on the pharmaceutical industry. .
Through practical workshop exercises, interactive discussions and real-life case studies, this training aims to provide useful tools for the participants to build eCTDs from the ground up. Advice on industry's best practice, as well as submission pitfalls from the reviewer's perspective will be introduced to help the participants in formulating the best strategies and employing the most practical tools to enhance the success of their electronic submissions.
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:
Session 1: Introduction and Overview
Session 2: eCTD Fundamentals – the Basics
Session 3: eCTD Fundamentals – Dossier Preparation
Session 4: eCTD Review & Validation
Session 5: Workshop – Building a submission based on eCTD format
Session 6: eCTD Lifecycle Management
Session 7: Workshop – eCTD Lifecycle Management
Session 8: Global Comparison & Contrast
Upon completion of this course, participants will be able to:
"The Course Director was great- knowledgeable and engaging! She was energized and funny and kept us laughing. Definitely recommend her!." Gretchen G., Submission Coordinator, Cutanea Life Sciences
"The Course Director was a great instructor! Engaging, funny, and extremely knowledgeable." Nicole B., Regulatory Chemist, Zevacor Molecular
"The Instructor is a very experienced professional. He has an in-depth knowledge of the eCTD structure and process which is very relevant in the industry." Tina S., Reg. Project Manager, BioMarin Pharmaceuticals, Inc.
"The size of the class really made a huge difference when it came to the needs of each attendee. It allowed the Course Director to answer questions more thoroughly, to interact with us, and encourage us to interact more. The Course Director was organized and open to discussion, which allowed us to communicate with him in a friendly but professional manner." Rebecca H., Sr. Doc. Coor. Reg. Affairs, Teva Pharmaceuticals
"Very thorough presentation. Excellent handouts" Donna B., Director Medical Writing, Sepracor
"This course was excellent! The Course Director did a nice job of presenting all the material." Michele C., Senior Regulatory Assoc., Par Pharmaceuticals
"The Instructor covered a great deal of material in two days and was very knowledgeable on many aspects of FDA Inspections. I would recommend this course to my colleagues." David M., Director, Bayer
"The Course Director had a wealth of knowledge to share along with a good deal of practical experience." Data Management, Merck
"Course content was excellent! It provided a fundamental understanding of the regulatory process." Tara M., Regulatory & Compliance Supervisor, Pfizer
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The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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