Who will benefit from this module?
This module is an essential tool for regulatory affairs and compliance staff and specialists in data handling, knowledge management or documentation. All those involved in drug development and who contribute to regulatory submissions will also wish to familiarise themselves with its contents.
- Describe the structure, requirements and functionality of the eCTD.
- Outline XML basics and the architecture of the eCTD.
- Discuss Document Type Definitions (DTDs) and schemas.
- 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.
CPD Points: 2.5
Assessment: Multiple-choice mastery assessment.
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, life cycle management and structure of the five modules.
Creating an eCTD submission - This session explores the workflow around planning, creating and submitting an eCTD - particularly setting up the modules, and migrating and validating the data.
Special components - Features of the Canadian, EU, Japanese and US DTDs/schemas and the STF specification are outlined.
Tools - This session includes a case study and an eCTD checklist to assist learners when compiling an eCTD submission.