Clinical Trials Information System (CTIS) bitesize talk: How to submit a transitional trial in CTIS
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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 how to create and submit transitional trials in Clinical Trials Information System (CTIS). Sponsors will also have the opportunity to ask questions on this CTIS topic before and 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 (url: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-training-support), including the CTIS sponsor handbook (url: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-training-support#handbook-for-clinical-trial-sponsors-section) and the online modular training programme (url: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-ctis-online-modular-training-programme#sponsor-workspace-section) focusing on Module 23 (Transitional trials).
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.
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We encourage event participants to submit questions related to sponsor preparedness in advance of the webinar (use code:# bt21jun).
The most popular questions submitted in advance of the event will be answered by speakers during the panel session.
Please provide your questions between 1- 14 June 2023.
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