The European Medicines Agency (EMA) is organising a webinar for small and medium enterprises (SMEs) and academia on the Clinical Trial Regulation (Regulation (EU) No 536/2014) and the Clinical Trials Information System (CTIS).
The webinar will take place on November 29, 2021 from 09.00 – 13.15 CET.
The webinar is being organised as a training event and will present:
- 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
Attendance at the webinar is by registration only and open to companies that have been assigned SME status by EMA, academia and representatives of stakeholder organisations. There is no registration fee for this event.