Title: Electronic Submission in the EAEU - technical and regulatory challenges
Duration: 60 minutes - Available On Demand
The first part of this webinar will provide an overview and update on the new Regulatory legislation in the Eurasian Economic Union (EAEU) and its impact on pharmaceutical companies intending to apply for new or to preserve existing Marketing Authorisations in the Region. It will also explain the key features of the mandatory eCTD-like EAEU electronic submission format.
The second half will feature a live demonstration of compiling submissions based on the EAEU Electronic Submission Format using Lorenz docuBridge software. In particular, we will look at compiling Modules 1, 3 and 5 as well as lifecycle operations while focusing on the main differences to eCTDs such as EU and US.
- EAEU submission requirements
- EAEU Regulatory Legislation implementation
- Features of the EAEU eSubmission format
- Compilation and Submission Life Cycle of EAEU electronic submissions
- Main Differences to EU and US eCTDs
Director, Principal Consultant Regulatory Operations Industry/Agency Liaisons, PharmaLex
Karl-Heinz Loebel has spent the last 15 years in Regulatory Affairs, focusing on electronic submission, data management and systems implementation. He has been responsible for PharmaLex eCTD submissions in traditional ICH regions ever since and is now also coordinating the extension of the company’s publishing capabilities to the requirements of the regions that joint the eCTD community most recently, like China and EAEU.
Product Consultant, Lorenz
Kristina Roberson has 8 years of software training experience and conducts docuBridge trainings for companies around the world as a member of the Lorenz Education and Consulting team. With the recent addition of the EAEU-specification China to the docuBridge suite, she also provided specialized user pilot training for customers interested in using this feature.