Clinical Trials Information System (CTIS): Information day

The Clinical Trials Information System (CTIS) is the backbone of the Clinical Trials Regulation (Regulation (EU) No 536/2014) and acts as a the single-entry point for clinical trials assessment, authorisation and supervision in the EEA.

CTIS also enables the publication and registration of clinical trials in the CTIS public website, a public register with search and download functionalities.

CTIS provides harmonised and simplified end-to-end electronic application procedures over the lifecycle of clinical trials across the EU/EEA.

Since the launch of CTIS on 31 January 2022, only 15 months remain to transition ongoing trials from the previous legislative framework of the Clinical Trials Directive (2001/20/EC) to the Clinical Trial Regulation (536/2014).

The virtual event aims to support sponsors of clinical trials in preparing and proceeding with the transition to meet the deadline of 30 January 2025. Commercial and non-commercial sponsors with experience in transitioning trials as well as representatives from EMA and EU/EEA member states will share insights and best practices.

Ample time is foreseen for Q&A. The faculty invites participants to submit related questions by 03 October 2023 latest to emaevents@diaglobal.org

Featured topics:

• Transition period from the Clinical Trials Directive (2001/20/EC) to the Clinical Trial Regulation – regulatory and practical aspects
• Insights on preparation for transitioning clinical trials from sponsors’ perspective
• Insights on member states' procedures with regard to transitioning of clinical trials CTIS system metrics
• Upcoming training and event opportunities

This CTIS Virtual Information Day is aimed at CTIS users from:

• Pharmaceutical companies
• Small and medium-sized enterprises (SMEs)
• Academic organisations
• Contract Research Organisations (CROs)
• Member State NCAs
• Ethics Committee Members

• Register via DIA Europe

• Basel@DIAglobal.org