DIA and EXTEDO eCTD Submission Hands-on One Day Training

This hands-on training held by EXTEDO's eCTD expert Ralf-Peter Berg, enables participants to understand regional differences and global submission strategies. Compilation of US M1 and EU M1 is discussed in detail to empower users with updated information on these major ICH regions.

Agenda  |  Register Now

Program highlights include:

  • The necessary processes to create an eCTD for an EU and FDA submission.
  • A brief introduction in the eCTD basics
  • Creation of a Product Master Dossier, covering the Quality-relevant part of an eCTD.
  • EU Module1 - compile non-clinical and clinical studies

Learning Objectives:

At the end of this training, the participants should be able to:

  • Compile a technically validated eCTD for various regions
  • Maximize the reuse of compiled content
  • Understand eCTD publishing and technical validation
  • Understand the differences in the regional interpretations of electronic submissions
  • Consider the impact of various regional interpretations of eCTD specifications and guidelines on global submissions strategy

Target Audience:

Professionals in:

  • Regulatory Affairs
  • Regulatory Operations
  • Submission Management
  • Electronic Publishing

Contact & Registration:

Manoj Trivedi
Sr. Manager Business Development
Email: manoj.trivedi@diaglobal.org  |  Cell: +91 98 1977 7493