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EMA Clinical Trial Information System (CTIS): The Future User Perspective-Virtual Information Day

The EMA Clinical Trial Information System - Virtual Information Day will support users in preparing for the new way of submitting Clinical Trial Applications (CTA) through CTIS including a live demo of how to navigate the system.


Overview

The European Commission confirmed 31 January 2022 as the date of entry into application of the Clinical Trials Regulation EU No 536/2014 and the go-live of the Clinical Trial Information System (CTIS).

The objectives of this virtual information day are to help prepare users for the new way of submitting Clinical Trial Applications (CTA) through CTIS.

It will provide –on a high level- an overview of key aspects of CTIS for future users to consider.

Ample time is foreseen for a live demo presenting users an overview of the two restricted workspaces for sponsors and authorities.

Furthermore, current status and experience with sponsor users’ preparedness will be shared.

The information day will close with an update on access to CTIS training material and EMA support.

The information day will not cover aspects of the registration process nor user access management in CTIS. More information on those topics can be found on the dedicated EMA CTIS webpages.

Featured topics

  • The Clinical Trials Regulation and key aspects for users to consider when preparing for CTIS
  • CTIS live demo of sponsor and authority workspaces: how to navigate the system
  • Sponsor perspective on user preparedness
  • Update on Access to CTIS training material and support

Who should attend?

This EMA CTIS Virtual Information Day is aimed at all CTIS users:

  • Clinical Trial Sponsors
  • CROs
  • Member State NCAs
  • Ethics Committee Members

 

Program Committee

  • Charalampos  Drosos
    Charalampos Drosos CTIS Change Management Officer, Data Analytics and Methods Task Force
    European Medicines Agency, Netherlands
  • Sarah  Scales
    Sarah Scales CTIS Change Management Officer, Data Analytics and Methods Task Force
    European Medicines Agency, Netherlands
  • Pieter  Vankeerberghen
    Pieter Vankeerberghen Head of Clinical Trials
    European Medicines Agency, Netherlands
  • Fia  Westerholm, DVM, MSc
    Fia Westerholm, DVM, MSc Programme Assurance Manager
    European Medicines Agency, Netherlands
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Agenda Questions

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+41 61 225 51 51


Registration Questions

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+41 61 225 51 51