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Dátum
Umiestnenie
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 Union (EU) and the European Economic Area (EEA).
This CTIS Bitesize Talk focuses on the Role Management functionality in CTIS, highlighting the new features and the new Safety user roles introduced with the CTIS Safety Module.
The session also covers the new access process for the CTIS Training Environment, including:
We encourage all relevant stakeholders to attend and make the most of this opportunity to get ready for the upcoming implementation.
The event is live broadcast, and no registration is required for those wishing to follow the live broadcast on EMA’s website.
Live participation via Slido
We encourage event participants to submit questions via Slido related to sponsor preparedness in advance of the webinar, by 10 November (use code: #bt18nov). The most popular questions submitted will be answered by speakers during the panel session.
The event is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs), and academic organisations.
To get the most from the session, sponsors are encouraged to review the available guidance beforehand:
EMA cannot provide attendees certificates of attendance for this event.
A recording of the event is published after the session. Please note that processing and publication can take up to 60 days.
To receive updates on the availability of CTIS event recordings, subscribe to the clinical trials newsletter.
Video quality
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To watch the video in full screen mode, click the arrow icon to watch it on Panopto.