Filing eCTD Submissions Training Course

Course overview

The eCTD (electronic Common Technical Document) is now mandatory for submissions in the EU and global regulatory agencies are also moving towards the eCTD as a standard submission process.

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission. The expert speakers will share their practical experiences of the eCTD and discuss how to implement efficient processes to build and publish submissions in both the EU and US. You will consider the eCTD validation criteria and how to prepare for these in your submissions as well as discuss life cycle management. An interactive case study session will explore eCTD submission challenges and logistics and help consolidate learning.

Benefits of attending:

• Clarify the main components of the eCTD
• Learn how to implement efficient processes to build, publish and deliver regulatory eCTD submissions
• Discuss practical experiences of eCTD submissions in the EU and US
• Consider life cycle management for eCTD submissions

Who should attend?

The course will be beneficial to regulatory professionals involved in the preparation of electronic submissions. It will also be of interest to anyone responsible for providing content for the eCTD or who wants to understand the eCTD better.

Introduction and overview of the eCTD

• The global regulatory framework

What are the main components of the eCTD?

• Metadata
• Documents
• XML backbone

Implementing efficient processes to build, publish and deliver regulatory eCTD submissions

The benefits of using MS Word template

• Demonstration of template

Considerations for outsourcing

• Why outsource eCTD vs in-house?
• How to select the right eCTD partner
• Best practices for an outsourcing process

Practical experiences of submitting eCTDs

• Experiences submitting in EU
• Experiences submitting in US

Case study – eCTD submission challenges and logistics

• Recent client MAA
• Metadata
• Life cycle considerations for client

Review of eCTD validation criteria

• Considerations (inherit zoom, filenames, node extensions etc)
• How to prepare for these (to prevent validation issues)

Life cycle management for eCTD submission

• Granularity considerations
• Combining documents
• Use of operators

Key points to take away for successful eCTD submission