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
Director, Principal Consultant Regulatory Operations Industry/Agency Liaisons
Karl-Heinz Loebel – a chemist by education – has spent the last 15 years in Regulatory Affairs, focussing on electronic submission, data management and systems implementation. He is an acclaimed expert in eCTD submissions. He has also been a member of EMA’s XEVMPD Implementation Working Group since 2013 and is a member of the IDMP Implementation Task Force since 2015.
Dr. Klaus Menges
PharmNet.Bund Authorised Representative at BfArM // Independent Consultant
Dr. Klaus Menges has worked for the German NCA (BfArM) for more than 30 years and became an expert in regulatory topics as well as in IT solutions in drug the regulatory affairs area. For BfArM he substantially contributed to the PharmNet.Bund project and was engaged in the development of the eCTD next major version (v 4.0). Klaus represented the BfArM in the Telematic Change Management Board and several working groups in this area and was nominated as Regulatory Chair in the ICH WG M8 on electronic submission. He works as an independent consultant since 2019.