This webinar is dedicated to our customers in China and organized together with our Chinese partner NeoTrident.
In 2020, NMPA CDE released a new M1 structure and we are expecting the final validation criteria for eCTD in China soon. EXTEDO's software solutions already include the Chinese eCTD v1.0 specification. How does the Chinese eCTD specification look like and what are the implementation timelines? These and other questions will be answered in our complimentary webinar: "The Basics of eCTD Submissions in China"
In our complimentary webinar, we will share the basics of eCTD submissions, China-specific details as well as the current timelines in China. Additionally, we will look at the current eCTD structure.
In the live demo following the theoretical part, you will see how a Chinese eCTD submission is created using eCTDmanager.
1. EXTEDO Company Overview (Thomas Kessler, EXTEDO)
2. Neotrident Company Overview (Tao Shi, Neotrident)
3. Introduction to eCTD Submissions in China (Dr. Anna Thadigsmann, EXTEDO)
- Introduction to eCTD and benefits of the standard
- Timelines in China
- The Chinese eCTD standard in detail
- Workflow of an eCTD submission
- Validation criteria of an Chinese eCTD dossier
4. Live Demo: Creation and Validation of an eCTD Dossier (Maren Müller, EXTEDO)
5. Questions & Answers
Date: Thursday, 29 April 2021 | 08:00h CEST (Berlin, Paris) | 14:00h CST (Beijing, Shanghai)
Duration: 60 Minutes