Sponsored Webinar-Evolution of Structured Data Submissions

Sponsored Webinar-Evolution of Structured Data Submissions
FREE SPONSORED WEBINAR - The webinar covers essential terminology and concepts related to eCTD version 4.0, including key terms such as CoU (Context of Use), CoG (Context of Group), CV (Controlled Vocabulary), KW (Keywords), FWC (Forward Compatibility), and lifecycle operators, which are crucial for understanding and working with this updated electronic submission standard.

28 October - 14:00 - 15:00 GMT / 15:00 – 16:00 CET
Evolution of Structured Data Submissions  

The webinar covers essential terminology and concepts related to eCTD version 4.0, including key terms such as CoU (Context of Use), CoG (Context of Group), CV (Controlled Vocabulary), KW (Keywords), FWC (Forward Compatibility), and lifecycle operators, which are crucial for understanding and working with this updated electronic submission standard.
 
It also outlines the regional specifics for implementing eCTD v4.0 across various regions, including the European Union (EU), United States (US), Canada (CA), Switzerland (CH), and Australia (AU), highlighting differences and requirements particular to each jurisdiction.
 
Additionally, the webinar provides a summary of changes between eCTD versions 3.2.2 and 4.0, detailing improvements and updates that make version 4.0 more efficient, such as enhanced data structuring, improved lifecycle management, and better-defined metadata, contributing to more streamlined regulatory submissions. In a very short demo, the participants will see how an eCTD v4 looks like in a viewer.

Learning outcomes
- eCTD v4.0 terminology and concepts (CoU, CoG, CV, KW, FWC, Lifecycle operators).
- Regional Specifics for eCTD v4.0 in EU, US, CA, CH and AU. 
- Summary of Changes between eCTD versions (3.2.2 vs. 4.0).

Target Audience
Regulatory operations professionals, especially for those dealing with eCTD publishing and any other regulatory affairs professional interested in the field. 

Speakers:


Maren Müller, Product Manager, EXTEDO
Maren joined EXTEDO GmbH in 2011 and started in the Customer Care department to support with regulatory knowledge and software training. After a while, she moved as a Senior Business Consultant to the Regulatory Competence Center, where she worked closely with many health authorities and pharmaceutical companies in different projects. Since 2017, she is a member of the Product Management Team, responsible for several Apps in the Submission and Document Management Hub. As a Product Manager, she still works very closely with different customers around the globe. With over 14 years of experience in regulatory consulting and product management, Maren brings practical expertise and deep industry insights.


Daniel Langa, Regulatory Affairs Associate Director | EMA SME, Asphalion

This webinar is sponsored by Extedo



Disclaimer: Whilst TOPRA is running this webinar for Extedo, this is not an endorsement of Extedo, Extedo's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

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Pricing

  • Members: free
  • Non-members: free

Terms and Conditions

By purchasing this webinar, you are agreeing to TOPRA's training terms and conditions.


 
When
28/10/2025 14:00 - 15:00
Where
ONLINE
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