Title: The EAEU electronic Submission Challenge – New legal requirements for electronic submissions in the Eurasian Economic Union
Date: Tuesday, January 28, 2020
Time: 04:00 PM Central European Time
Duration: 1 hour
The Eurasian Union (EAEU) is working to implement a submission process that is similar to the eCTD model and also other ICH guidelines. The new regulation affects all marketing authorization holders as well as all new drug applications. Our upcoming webinar is a must-attend for anyone who wants to stay up-to-date and implement the new requirements smoothly.
- Understanding the submission requirements in the region
- Identifying the technical differences between EAEU and ICH eCTD requirements
- Adopting your submission processes to comply with the technical requirements
Dr. Karl-Heinz Loebel
Director, Principal Consultant Regulatory Operations Industry/Agency Liaisons
Dr. Karl-Heinz Loebel – a chemist by education – has spent the last 13 years in Regulatory Affairs, focussing on electronic submission, data management and systems implementation. He has been a member of EMA’s XEVMPD Implementation Working Group since 2013 and of the IDMP Implementation Task Force since 2015.