Webinar for small and medium-sized enterprises (SMEs) and academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS)
EventHumanClinical trialsSME
- The original event time is:
- Monday, November 29, 2021 - 09:00 - 13:30 Amsterdam time (CET)
Date
- , -
Location
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
Event summary
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 reportingrequirements
- 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.
The event will start at 09:00 and finish at 13:30 Amsterdam time (CET).
A video recording is available.
Video recording
Registration
- Registration closed.
- Only registered participants will be able to participate actively in the event.