Since 31 January 2023, the EU Clinical Trials Regulation No. 536/2014 (EU CTR) became mandatory for initial clinical trial applications in the EEA. These applications now have to be submitted through the Clinical Trials Information System (CTIS). The new requirements introduced by the EU CTR, coupled with the complex functionalities of the new portal often pose challenges to applicants, who should be aware of all that entails before working in CTIS.
The aim of this interactive demo is to help sponsors and CRO organisations navigate through the complexities of the EU CTR and CTIS, being able to ask questions on the way to ensure a deep understanding.