Clinical Trials Information System (CTIS): Information day
EventHumanClinical trials
- The original event time is:
- Thursday, October 17, 2024 - 13:30 - 17:30 Amsterdam time (CEST)
Date
- , -
Location
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
Event summary
Since 31 January 2023, it has been mandatory for sponsors to submit all initial clinical trial applications via CTIS. In less than 7 months, from 31 January 2025 onwards, sponsors will need to comply with their obligations under the CTR and its Delegated Acts for all clinical trials conducted in the EU/EEA.
Furthermore, the revised transparency rules for the Clinical Trials Information System (CTIS) will become applicable on 18 June 2024, with the launch of a new version of the CTIS public portal.
The virtual event aims to support sponsors of clinical trials in proceeding with the transition to meet the deadline of 31 January 2025. Speakers will share detailed metrics on transitioned clinical trials. In addition, comprehensive guidance and practical examples regarding the following steps in transitioning trials will be presented.
Additionally, during the event representatives from EMA will provide an overview of the revised transparency rules as well as a demonstration of the new functionalities of CTIS new public portal.
Ample time is foreseen for Q&A. The faculty invites participants to submit related questions by 08 October 2024 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
- Overview of the revised transparency rules
- Demonstration of the new functionalities of CTIS new public portal
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