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 2022and 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 trialson how to prepare for the main changes brought by the Regulation and its impact on their trial-related activities.
Topicspresented during the webinar include:
- an overview of the Clinical Trials Regulation
- an introduction to the new process for submitting clinical trial informationin the European Union/European Economic Area
- functionalitiesof 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.