Clinical Trials Information System (CTIS) bitesize talk: Modifications

Date: 31/05/2022
Location: Online, 16:30 - 18:00 Amsterdam time (CEST)

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 Economic Area.

This bitesize talk on CTIS provides an opportunity for sponsors to learn about the Modifications that can be made to a clinical trial application in Clinical Trials Information System (CTIS). Sponsors will also have opportunity to ask questions during the event.

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 CTIS Sponsor Handbook and the online modular training programme focusing on Module 05 (Manage a clinical trial through CTIS) and Module 10 (Create, submit and withdraw a clinical trial). 

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 takes up to 60 days. Please subscribe to the Clinical Trials newsletter for updates on the availability of CTIS event video recordings.

Live participation via Slido

At certain points throughout the meeting, participants will be able to ask questions or give their input via the audience interaction tool Slido. Once the event begins, please go to and enter the event code provided on the event day: #may31

Interaction via Slido is voluntary, and you may opt to remain anonymous. If you chose to use Slido, you consent to the processing of your personal data as explained in the EMA Data Privacy Statement for Slido.

Video recording

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