Clinical Trials Information System Webinar: Second Year of Transition
Table of contents
The Clinical Trials Information System (CTIS) was launched on 31 January 2022, starting the clock for the three-year transition period from the Clinical Trials Directive to the Clinical Trials Regulation. Since 31 January 2023, it is mandatory for sponsors to submit all initial clinical trial applications via CTIS.
The European Medicines Agency (EMA) is organising this open event to provide:
• reflection on the implementation of the Clinical Trials Regulation;
• reflection on Transitional Trials and Ethics Committee assessment procedures;
• update on the current status of CTIS.
This EMA-hosted webinar is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations. No certificates of attendance will be issued for this event.
The event will be broadcast live. A video recording is made available after the event. Processing and publication of the video recording typically take up to 60 days.
Attendees are invited to fill out a short feedback survey via Slido that will be available after the event.
You should see the live broadcast on pressing the 'play' icon in the video window, or a message stating that we are not currently broadcasting.
To optimise video quality, once the video is playing we recommend clicking on the ‘HD’ symbol in the video window then selecting the '720p' option.
If the video window is blank, or if you experience other difficulties viewing the broadcast, please try connecting directly to the IBM channel.
For technical information about the required network security settings, please see this IBM help page.
For further assistance, please consult the EMA service desk.
We encourage event participants to submit questions related to sponsor preparedness in advance of the webinar (use code: #InfoJul2023).
The most popular questions submitted in advance of the event will be answered by speakers during the panel session.
Please send your questions between 1- 17 June 2023.
Interaction via Slido is voluntary, and you may opt to remain anonymous. If you choose to use Slido, you consent to process your personal data as explained in the EMA Data Privacy Statement for Slido.