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AN OVERVIEW OF THE eCTD - Are you up to date?

Short course

In The Rembrandt Hotel, London ()

£ 575 + VAT

Description

  • Type

    Short course

  • Duration

    1 Day

This one day meeting is designed to be an introduction to the topic of the electronic Common Technical Document (eCTD). The day is a mix of presentations on the subject, including detail about the specification itself and practical considerations for implementing the eCTD in your organisation. Suitable for: The course is primarily aimed at those involved in the creation and submission of eCTDs, from both a business/regulatory background and IT/support aspect. However, the course content will also be of interest to managers in these groups or to the creators of submission content or anyone else who wants to understand the eCTD better.

Important information

Documents

  • eCTD

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Reviews

Teachers and trainers (1)

Geoff Williams

Geoff Williams

Site Head of Regulatory Operations for Roche

Course programme

This one day meeting is designed to be an introduction to the topic of the electronic Common Technical Document (eCTD).

The day is a mix of presentations on the subject, including detail about the specification itself and practical considerations for implementing the eCTD in your organisation.

Topics to be covered include:-

  • Introduction and overview of the eCTD
  • What are the main components of the eCTD
  • The ICH and European eCTD specifications
  • Transitioning from paper submissions to the eCTD
  • Considerations when selecting tools for the eCTD
  • Process changes for the eCTD
  • Practical experiences of submitting eCTDs

AN OVERVIEW OF THE eCTD - Are you up to date?

£ 575 + VAT