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In the second part of our Agency eCTD v4 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.

EXTEDO's Agency Masterclass eCTD v4 is free of charge and exclusively reserved for employees of Health Authorities. After the session, you will receive a participation certificate and the recording. Please use your work address to register.

If you can not join the Agency Masterclass, please do also consider eCTD v4 Masterclass Reloaded - Part I: Recap & Update!

Your Agency eCTD v4 Masterclass teacher, Anjana Pindoria-Rettenberger: 

Anjana Anjana, Director of Product Strategy, brings over 20 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.    


Topics of Agency eCTD v4 Masterclass - Part 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 v4framework.
  • The need for a robust assessment solution for re(v)iewing of eCTD applications


Use this exclusive opportunity to continue your journey to eCTD v4 mastery. Reserve your spot today and stay tuned for the next parts of our Agency Masterclass eCTD v4.

Register now for Agency Masterclass eCTD v4 - Part III: Mastering Meta - Exploring eCTD v4's CVs and IDs!