Pharmaceutical Regulatory Affairs: Electronic Common Technical Document (eCTD)

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Program/Course ID: PRA004 Enrollment Period: 12 months. Average Learning Time: ~. Additional Resources: Supplemental materials/activities. Credit Hours: 3 credits. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials. Demonstration: Four (4) free trial courses are available. Group/Employee Training: Click here to request a quote. Final Assessment: Multiple choice; unlimited attempts. Certificate: Encrypted PDF with validation QR barcode.

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2024 UPDATE:
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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Outline: 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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Comments: For quotes or invoices please provide the course(s) and number of students.	Pharmaceutical Regulatory Affairs: Electronic Common Technical Document (eCTD)