December 2022: CTIS Update

European Medicines Agency updated about the upcoming ‘Clinical Trials Information System (CTIS) sponsor end-user training program’ events over the What’s New Section on December 13, 2022:

EMA will held three sponsor end-user training programs on the below dates for sponsors (commercial and non-commercial) and contract research organizations (CROs):

These training programs support sponsor user preparedness for the new CTIS by demonstrating the functionalities of the system, such as user management, how to submit an initial application as well as substantial and non-substantial modifications. Also, topics like how to manage the life cycle of a clinical trial and how to apply deferral rules and respond to a Request for Information (RFI) will be covered.

The agenda and registration link for the sponsor end-user training program to be held in February is now available on the event page.