Reg Ops SPIN Webinar: Understanding EAEU Requirements

Reg Ops SPIN Webinar: Understanding EAEU Requirements
The TOPRA Regulatory Operations SPIN are pleased to announce our next webinar, in which we will have the pleasure of hosting Karl-Heinz Loebel (Director, Principal Consultant at PharmaLex) as he delivers insight into the EAEU procedure. Karl-Heinz will be joined by speakers from Pfizer who will share some real-life experience of the EAEU procedure.

 

During this webinar, the speakers will dive deeper into the EAEU specification and cover the proposed content, structure and technical compliance of the electronic submissions as well as sharing some practical experience of publishing submissions to comply with the requirements. 

EAEU context
On 3 August 2017, the Committee of the Eurasian Economic Union (EAEU) released the standards for EAEU electronic submissions. Mandated usage of the EAEU specifications for regulatory esubmissions is anticipated to begin in early January 2021 for any new registrations with mandated usage for all other submissions expected in 2026. 

Pricing

  • This event is free for TOPRA members.
  • Non-members can attend by registering and paying a £45 fee (which will include two months temporary TOPRA membership).

How to register

Members:

  • Use the 'Register now' form above to log in to the site with your TOPRA Member username and password.
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Non-members:

  • If you already have non-member account for this site, log in and then click the 'Register Myself' link that will appear below.
  • If you do not have an account, create an account, then log in and click the 'Register Myself' link that will appear below.
When
17/07/2020 13:00 - 14:00
Where
ONLINE
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