Clinical Trials Information System (CTIS) bitesize talk: Change of sponsor in CTIS
EventHumanClinical trials
- The original event time is:
- Wednesday, March 5, 2025 - 15:30 - 17:00 Amsterdam time (CET)
Date
- , -
Location
- OnlineEuropean Medicines Agency, Amsterdam, the NetherlandsLive broadcast
Event summary
CTIS is the business tool of the EU Clinical Trials Regulation (Regulation (EU) No 536/2014) and it
acts as a single entry point for clinical trial authorisation and supervision in the European Union (EU) and the European Economic Area (EEA).
This CTIS Bitesize Talk offers an opportunity to highlight the functionalities that allow sponsor users to make changes on the sponsor section of clinical trial. Sponsor users can submit a particular type of Substantial Modification (SM) application to request the change of the sponsor organisation of their trials. The change is effective once the SM is authorised by all MSCs. In addition, sponsor users, by submitting a non-SM that affects Part I, can change specific details of sponsor (address, contact details), without changing the sponsor organisation.
The event is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations. EMA cannot provide attendees certificates of attendance for this event.
To be better prepared for this event, sponsors are encouraged to consult the CTIS training and support materials, including the Clinical Trial Information System (CTIS) - Sponsor handbook and the online modular training programme. The processes of the sponsor organisation change and the sponsor details are mentioned in the Module 10 – FAQ sheet (FAQ 4.10 & 5.7 respectively), as well as in the NewsFlash issues of 26/07/2024 and 03/05/2024 respectively.
The event will be live broadcast and no registration is required for those wishing to follow the live broadcast on EMA’s website.
A video recording is made available after the event. Processing and publication of the video recording typically take up to 60 days. Please subscribe to the clinical trials newsletter for updates on the availability of CTIS event video recordings.
Participation via Slido
We encourage event participants to use Slido and to submit questions related to sponsor preparedness in advance of the webinar (use code:#bt5mar). The most popular questions submitted in advance of the event will be answered by speakers during the panel session.
Please provide your questions by 19 February 2025, 12:00.