ACT EU Training for non-commercial sponsors: Transitioning trials to CTIS
9 February 2024 10:00-13:00 CET
Location: Online/ European Medicines Agency, Amsterdam, the Netherlands, Live Broadcast
This training event aims to support non-commercial sponsors of clinical trials in transitioning their clinical trials that are expected to continue after 30 January 2025 from the Clinical Trials Directive to the EU Clinical Trials Regulation (Regulation (EU) No 536/2014). Moreover, the event will provide useful training in preparing new clinical trials following the Regulation (CTR).
From 31 January 2025 onwards only the CTR and its Delegated Acts will apply. Sponsors, therefore, need to transition any trials that will continue after 30 January 2025 from the Clinical Trials Directive to the legal framework of the CTR.
During the event, representatives from the Member States and EMA will provide guidance and resources to support non-commercial sponsors in transitioning their trials to the Clinical Trials Information System (CTIS). CTIS is the business tool of the CTR, and it acts as a single-entry point forauthorisation and supervision in the European Economic Area.
The event is addressed to non-commercial sponsors with limited or basic experience in CTIS. To be better prepared for this event, sponsors are encouraged to consult the CTIS training and support materials, including the CTIS sponsor handbook and the online training modules. Sponsors will also have the opportunity to ask questions on the topic before and during the event.
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.