Clinical Trials Information System (CTIS) bitesize talk: Training materials, CTIS pre-requisites, and updates on transparency rules
EventHumanClinical trials
Latvian is available via eTranslation, the European Commission's machine translation service.
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Date
- Trešdiena, 29 Novembris 2023, Visu dienu
Vieta
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
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 aims to provide sponsors with a reminder on the CTIS training materials, the prerequisites for sponsors before using CTIS, and the updates on the transparency rules. Sponsors will also have the opportunity to ask questions on this CTIS topic before 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: