Clinical Trials Information System (CTIS): Information day
Event
Human
Clinical trials
- The original event time is:
- Tuesday, October 17, 2023 - 13:30 - 17:30 Amsterdam time (CEST)
Date
- , -
Location
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
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 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