Complimentary Webinar: Regulatory Challenges and Opportunities in the EAEU

Inpharmatis and EXTEDO invite you to our joint complimentary webinar "Regulatory Challenges and Opportunities in the EAEU".

In this webinar, we will discuss the regulations and requirements for electronic submissions in the Eurasian Economic Union (Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan) and show you, how Inpharmatis and EXTEDO can support you in getting your products on the EAEU market faster.

Konstantin Koshechkin, the leading expert of the Russian Federation Health Authority will present experiences with EAEU submissions at regulatory agency level, expanding on recommended approaches and strategies for submissions.

EAEU expert Polina Dombure from EXTEDO's partner Inpharmatis will talk about the challenges when submitting electronic submissions in the EAEU countries.
She will give useful hints what needs to be considered when creating and validating these submissions and which regulatory strategy would help you in this region. 

Maren Müller will demonstrate how EXTEDO's Word templates and the apps eCTDmanager and eSUBmanager could streamline your authoring and submission processes regarding the EAEU countries by offering compliant templates, automated processes and useful functionalitites.

Following the presentation the speakers will answer your questions in the Q&A session.

Agenda

1. Introduction

2. Practical experience in implementing and working with electronic systems in EAEU (Konstantin Koshechkin, Russian Federation Health Authority)

3. EAEU regulatory landscape overview - challenges and opportunities 
(Polina Dombure, Inpharmatis)
•    Regulatory strategy, PIL new requirements ​
•    Interaction and responsibilities – HQ / EAEU offices
•    EAEU e-submission challenges at industry level
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4. Demo: How EXTEDO solutions support your EAEU submissions
(Maren Müller, EXTEDO)

5. Q&A Session

Event Details and Registration

Monday, 16 November 2020
08:00 h EST (NY, Philadelphia)
13:00 h GMT (London, Lisbon)
14:00 h CET (Madrid, Berlin)
16:00 h MSK (Moscow, Minsk)

Duration: 90 Minutes
Participation is free of charge.