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In our Masterclass IV, participants will gain a comprehensive understanding of the new functionality of document relationship management in eCTD v4.0. From an overview of document relationships to an exploration of the "One:Many" and "Many:One" relationships, this session will empower you with the knowledge needed to harness the superpower of document dynamics.

Your Masterclass teacher, Anjana Pindoria-Rettenberger:       

Anjana Pindoria-Rettenberger, Director of Product Strategy at EXTEDO, continues to lead our exploration into eCTD v4.0. With her extensive regulatory experience and strategic insights, Anjana is your trusted guide in mastering the intricacies of document dynamics.

Topics of Masterclass IV include:

  • Overview of document relationships and their significance in eCTD v4.0 submissions.
  • Exploration of "One:Many" relationship as well as insights into the "Many:One" relationship and the implications for document management.
  • Overview of the concept of "Where Used" and its role in tracking document usage throughout the submission process.
  • Understanding the impact of document dynamics on regulatory compliance and submission efficiency, as well as its benefits and challenges.


Use this exclusive opportunity to continue your journey to eCTD v4.0 mastery. Reserve your spot today and stay tuned for the last part of our eCTD v4.0 Masterclass series. Register now for eCTD v4.0 Masterclass V- Seamless Transition: Balancing eCTD 3.2 Present with 4.0 Future