Clinical Trials Information System (CTIS) bitesize talk: Requests for information

Date: 28/04/2022
Location: Online, 14:00 - 15:30 Amsterdam time (CET)

Event summary

This bitesize talk on CTIS provides an opportunity for sponsors to learn about the Requests for Information, or RFIs, that may be received during the evaluation of a clinical trial application in Clinical Trials Information System (CTIS). Sponsors will also have opportunity to ask questions during the event.

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 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.

Prior to attending this event, sponsors are encouraged to consult the CTIS training and support materials, including the CTIS Sponsor Handbook and Module 11 'Respond to requests for information received during the evaluation of a clinical trial application' from the online modular training programme.

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.

Attendees are invited to fill out a short feedback survey that will be available after the event through this page.

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 www.slido.com and enter the event code “28april”.

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.

Live broadcast - 14:00 - 15:30 Amsterdam time (CET)

You should see the live broadcast on pressing the 'play' icon in the video window, or a message stating that we are not currently broadcasting.

To optimise video quality, once the video is playing we recommend clicking on the ‘HD’ symbol in the video window then selecting the '720p' option.

If the video window is blank, or if you experience other difficulties viewing the broadcast, please try connecting directly to the IBM channel.

For technical information about the required network security settings, please see this IBM help page.

For further assistance, please consult the EMA service desk.

Post event survey

Please fill out the feedback survey after attending the event.

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