The eCTD format has been established as a standard for submissions in more than 43 countries around the globe.
EXTEDO invites you to its complimentary webinar "Comparison between EU and US sequences and how to manage them in eCTD."
In this webinar, we want to take you on a regulatory tour with us to both sides of the big pond: USA and Europe.
Following the presentation, our regulatory expert Michael Faust (Business Consultant) will answer your questions in the Q&A session.
- EXTEDO Company Introduction
- Drug Application Procedure
- M1 formal differences
- Document Requirements
- Handling Studies
- US-Specific Elements: Grouping, Cross-Application References, Incremental Export
- EU-Specific Elements: Procedures, Multi-National Handling
- Submission Portals
- Q&A session