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In this Masterclass, you will gain a comprehensive understanding of the structural differences between eCTD versions 3.2 and 4.0. From a walkthrough of the new structure to an exploration of the “Context of Use” and its impact, this session will equip you with the knowledge needed to adapt to the changing regulatory landscape.

Your Masterclass teacher, Anjana Pindoria-Rettenberger:       

Anjana, Director of Product Strategy at EXTEDO, brings over 15 years of regulatory experience to the table. An esteemed expert in her field, Anjana's strategic insights and wealth of expertise have made her a trailblazer in shaping the discourse surrounding eCTD v4.0.       

Topics of Masterclass II include:

  • Deep dive into the structural changes between eCTD versions 3.2 and 4.0, understanding the implications for regulatory submissions.
  • Introduction to the “Context of Use” and its significance for applicants in the eCTD v4.0 framework.

Use this exclusive opportunity to continue your journey to eCTD v4.0 mastery. Reserve your spot today and stay tuned for the next parts of our eCTD v4.0 Masterclass series. Register now for eCTD v4.0 Masterclass III - Mastering Meta: Exploring eCTD v4.0's CVs and IDs