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