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.
Key learning objectives:
- 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
