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Filing eCTD Submissions Training Course

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

13 Apr 2021

& 18 Oct 2021 , 19 Oct 2021

Book now

Details

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.

Programme

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

Book now

Book now

13 Apr 2021
Live webinar
13 Apr 2021
Live webinar
GBP 599 499
EUR 859 719
USD 97 814
Until 2 Mar*
Enrol now
to attend
Live webinar
18 Oct 2021
Face-to-face, (venue not yet confirmed)
18 Oct 2021
Face-to-face
(venue not yet confirmed)
GBP 699 599
EUR 979 839
USD 1,09 934
Until 6 Sep*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 1 day of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
19 Oct 2021
Live webinar
19 Oct 2021
Live webinar
GBP 599 499
EUR 859 719
USD 97 814
Until 7 Sep*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

This course qualifies for 6 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

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  • Veeva Systems