Virtual Classroom Training

Bespoke interactive e-learning

This training provides understanding of the eCTD structure, including architecture, compliance assessment, and publication tools. The course covers document compliance criteria, validation tools, and the eSubmission process, including existing portals.

Date: June 7th, 2024

Type: Virtual Classroom Training

Duration: Half day (afternoon only)

Who should attend?: Pharmacists, Regulatory Affairs Officers and all staff involved in the MA dossier and in charge of publishing an eCTD.

Price on demand

Program

  1. PUBLISHING
  • Definition
  • History
  • Format
  • Introduction to ICH CTD
    • Structure
    • Region/country specific differences
  • Document Compliance
    • Definition
    • Validation criteria
    • Word document requirements
    • Pdf document requirements
  • eCTD
    • Regional information/envelope
    • Metadata
    • Lifecycle management/operators
    • Hyperlinks
  • Publishing Tools
  • Validation tools

 

  1. eSUBMISSION
  • Defintion & History
  • Presentation of existing portals

 

  1. WHAT’S NEXT ?
  • eCTD v4.0
  • KASA

Agnès MALO

Mélanie ALHUSBAN

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