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.
OBS pris for deltagelse er: 175 euro for academia. Læs mere og tilmeld her.