Clinical Trials Information System (CTIS): Information day

Date: 17/10/2023
Location: Online, 13:30- 17:30 Amsterdam time (CET)

Event summary

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

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

Contact point

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