Complimentary Webinar: Brexit-related Topics Relevant for Medical Product Registration

EXTEDO invites you to its complimentary webinar "Brexit-related Topics Relevant for Medical Product Registration".

During the webinar, Christina Stavrinidis (Publishing Manager EU & Regulatory Affairs Consultant, EXTEDO) and Frank Dickert (Senior Business Consultant, EXTEDO) will talk about the impact of Brexit on medical product registrations and several prodcedure types, the EMA relocation from London to Amsterdam and what comes with it. Christina and Frank will give recommendations what to do to be prepared and which issues might appear.

They will also explain how eCTDmanager and the Submission Gateway are affected and what needs to be considered with regards to pharmacovigilance.  Following the presentation the speaker will answer your questions in the Q&A session.

Agenda

  • EXTEDO Corporate Intro
  • General role of Brexit in medicinal product regulations 
  • History of Brexit related medicinal product registration topics 
  • EMA relocation and its impacts 
  • Initial recommendations and undertaken actions
  • Brexit and CP 
  • Implementation of Ireland/Northern Ireland (IE/NI Protocol)
  • Brexit and MRP/ DCP
  • Brexit and problems
  • eCTDmanager and Brexit 
  • Submission Gateway 
  • Brexit and Pharmacovigilance 
  • Q&A Session

Speakers

  • Christina Stavrinidis, Publishing Manager EU & Regulatory Affairs Consultant, EXTEDO
  • Frank Dickert, Senior Business Consultant, EXTEDO
     

Event Details and Registration

Wednesday, 16 December 2020
09:00h EST (NY, Philadelphia)
14:00h GMT (London, Lisbon)
15:00h CET (Madrid, Berlin)
16:00h EET (Cairo, Amman)

Duration: 60 Minutes
Participation is free of charge.