Pharmaceutical Regulatory Affairs: Electronic Common Technical Document (eCTD)
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Download Tuesday, June 09, 2026 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
.
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Free Trial CoursesOutline:Introduction: This session defines the eCTD and identifies advantages of using this submission format. Technical infrastructure: This session gives information on XML specification and style sheets and describes the eCTD backbone. Directory structure: This session looks at the eCTD hierarchy, lifecycle management and structure of the five courses. Submitting an eCTD: This session explores the workflow around planning and submitting an eCTD, particularly setting up The courses, migrating and validating the data, preparing the covering letter and submitting some eCTD parts on paper. It also reminds learners that a correctly completed eCTD is a valid legal document. Additional DTDs Canadian, EU, Japanese, American and STF: DTDs are described. Tools: This session includes a case study and an eCTD Checklist to assist learners when compiling an eCTD submission. Summary: Key point summary for all topics covered in The course. Ideal for a refresher or consolidation of learning points. | Objectives:Students completing this course should be able to: Describe the structure, requirements and functionality of the eCTD. Outline XML basics and the architecture of the eCTD. Discuss Document Type Definitions (DTDs). Explain how to build an eCTD. Specify regional differences. Discuss life cycle and change management. List criteria that will make an electronic application technically valid. Initiate electronic transfer to a regulatory authority. Create, submit and maintain an eCTD dossier throughout the life of a drug product. | |
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