CTIS newsflash - 16 May 2025

30 April 2025 EMA/147699/2025 European Medicines Agency CTIS newsflash – 16 May 2025 Introduction This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials. Previous issues of the CTIS Newsflash are available on the EMA website. The next issue will be circulated on 27 May 2025. CTIS downtime On 12 May some CTIS users experienced issues when trying to perform tasks in the system, most notably the system was slow to respond, and documents and tasks did not load correctly. EMA has implemented changes in the system and following these changes there has been a marked improvement in CTIS performance. The issue is now considered to be resolved. If you experience issues with CTIS, please contact the ServiceDesk. Key updates • EMA is hosting a CTIS Info day on 22 May 2025. The half-day informational webinar aims to provide an overview of CTIS, its optimisations, best practices, and upcoming developments. • EMA is redesigning the CTIS training materials for sponsor users, with the aim to improve navigation and ease of use based on stakeholder feedback. A stakeholder focus group was set up under the ACT EU Multi-stakeholder platform to validate the quality of the redesigned materials, expected to be published from June 2025. The exact launch dates will be announced in upcoming issues of this newsflash. Current operational experience with CTIS This section on CTIS metrics provides key data and trends. After a...