Introduction and Best Practices about Electronic Submissions in eCTD Format

Presented by Dr. Silke Nolkemper, Regulatory Affairs Specialist, EXTEDO GmbH

Introduction of eCTD

  • CTD vs. eCTD: differences between paper dossiers and electronic dossiers
  • General structure of an eCTD
  • Recommendation for industries/ applicants
    • Hardware / software specification
    • IT knowledge, applicant competency etc.

Details of the eCTD-structure

  • Files and folders
  • Meta data
  • Bookmarks and Hyperlinks
  • XML-backbone, Envelope
  • Lifecycle Attributes Experience in EU in e-CTD: how can several strengths and dosage forms be handled in one eCTD dossier (handling of specific sections)

eCTD Life Cycle Management

  • Submission Lifecycle, e.g. Variations, line Extensions
  • Document Lifecycle (add/replace/delete/append documents)
  • Specifications: EU, TH, other regions
  • Time of e-CTD preparation and format to be used

eCTD Best Practices

  • Do & Don't
  • The most common validation issues and how to solve them

EXTEDO is committed to follow the highest standards on Data Protection.

With a click on the button you allow EXTEDO to improve the user experience of this website. 
EXTEDO uses cookies for technical, performance and marketing reasons.
You can change your decision at any time.