Clinical Trials Information System (CTIS) bitesize talk: Part I-only applications and Part II requirements in CTIS
EventHumanClinical trialsData on medicinesMedicines
Date
- Wednesday, 30 August 2023, 15:30 (CEST) - 17:00 (CEST)
Location
- 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 provides an opportunity for sponsors to learn how to prepare for a Part I-only initial application when planning a clinical trial and how to complement the initial Part I-only application to satisfy the Part II requirements in the 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:
- Clinical Trials Information System: training and support
- CTIS sponsor handbook
- Online training modules
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. Subscribe to the CT Highlights newsletter for updates on the availability of CTIS event video recordings.