The CTIS experts will address all the questions related to system functionalities. Questions about the interpretation of the Clinical Trial Regulation and /or national processes are out of the scope of this event. The event is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations. It will be a live broadcast; no registration is required for those wishing to follow the live broadcast on EMA’s website. To make the best out of this session, attendees are highly recommended to first consult the available online training and support materials: CTIS online modular training programme, including frequently asked questions (FAQs) per module CTIS Sponsor handbook CTIS Reference materials for clinical trial sponsors EMA cannot provide attendees with certificates of attendance for this event. A video recording is made available after the event. Processing and publication of the video recording typically takes up to 60 days. Please subscribe to the Clinical Trials Highlights newsletter for updates on the availability of CTIS event video recordings.