Clinical Trials Information System (CTIS) bitesize talk: Requests for information
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.
Speakers' biographies - Clinical Trials Information System (CTIS) bitesize talk: Requests for information (PDF/97.09 KB)
First published: 05/04/2022
Last updated: 26/04/2022
Presentation - Clinical Trials Information System (CTIS) bitesize talk: Requests for information (PDF/795.69 KB)
First published: 26/04/2022