The Clinical Trials Information System (CTIS) is the single-entry point for clinical trials authorisation and supervision in the EEA. This includes a single clinical trial application dossier, covering clinical trial applications submitted to EU/EEA Member States, including submission to National Competent Authorities (NCAs) and Ethics committees (ECs) and registration of the clinical trial in a public register; all in one integrated submission. CTIS provides harmonised and simplified end-to-end electronic application procedures over the lifecycle of clinical trials across the EU/EEA.

The focus of this virtual information day – 9 months after the launch - is to share some practical advice regarding transitioning clinical trials from the Clinical Trials Directive (2001/20/EC) to the Clinical Trial Regulation (536/2014) as well as best practices on user management.

Furthermore, first insights on submissions and assessments of clinical trial applications and system metrics on usage of CTIS will be presented. It will also outline the importance of understanding timelines in CTIS, as will upcoming training opportunities and events.

Ample time is foreseen for Q&A. The faculty invites participants to submit related questions by 17 October 2022 latest to emaevents@diaglobal.org