Clinical Trials Regulation and the Clinical Trials Information System (CTIS)

The way clinical trials are conducted in the European Union/EEA will change when the Clinical Trials Regulation (Regulation (EU) No 536/2014) becomes applicable on 31 January 2022 and the Clinical Trials Information System (CTIS) will go live.

EMA is organising a webinar to inform small and medium-sized enterprises (SMEs) and academic sponsors of clinical trials on how to prepare for the main changes brought by the Regulation and its impact on their trial-related activities.

Topics presented during the webinar include:

• an overview of the Clinical Trials Regulation
• an introduction to the new process for submitting clinical trial information in the European Union/European Economic Area
• functionalities of CTIS, including transparency aspects and safety reporting requirements
• guidance and training material available for sponsors

Presentations are given by EMA experts and representatives of the European Commission, national competent authorities, SMEs and academia.