Some time ago, the Eurasian Economic Union (EAEU) Committee released the standards for EAEU electronic submissions. What will be the impact on applicants that would like to register a new drug in the EAEU? Is it the same as the ICH eCTD, only with a new regional module M1? What are the guidelines that need to be followed? These and other questions will be answered in our complimentary webinar.
Christina Stavrinidis (Regulatory Affairs Consultant & Publishing Manager EU), will explain the basics of EAEU Submissions and the special requirements for electronic submissions in Russia, Belarus and Kazakhstan. Then Maren Müller (Product Manager) will show you in a live demo how these submissions can be created in EXTEDO's eCTDmanager and reviewed in eSUBmanager.
1. EXTEDO Company Overview
2. EAEU Submissions
- Introduction to EAEU submissions
- Special requirements for Russia
- Special requirements for Belarus
- Special requirements for Kazakhstan
3. Live Demo: Creation and Validation of an EAEU Dossier
4. Questions & Answers
Date: Wednesday, 28 July 2021 | 09:00h GMT (London, Lisbon) | 10:00h CEST (Berlin, Paris) | 11:00h MSK (Moscow, Minsk) | 14:00h ALMT (Nursultan)
Duration: 60 Minutes | If the time does not fit for you, register anyway and we will send you the link to the recording.