EMA Webinar for SMEs and Academia on the Clinical Trials Regulation and the Clinical Trials Information System

EMA webinar

The way clinical trials are conducted in the EU will change when the Clinical Trials Regulation (Regulation (EU) No 536/2014) becomes applicable and the Clinical Trials Information System (CTIS) goes live on 31 January 2022.
The EMA is organising a webinar to remind SMEs and academic sponsors of clinical trials of the main changes brought by the Regulation and its impact on their trials-related activities.
The aim of the training is to give an overview of the Regulation and introduce the new process for submitting clinical trials information in the EU/EEA. In addition, it covers the functionalities of the Clinical Trials Information System (CTIS) as well as transparency aspects and safety reporting requirements. Guidance and training material available for sponsors are also presented.

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Webinar summary

WebinarEMA Webinar for SMEs and Academia on the Clinical Trials Regulation and the Clinical Trials Information System
Date29 November - November 29th, 2021
Time9:00 – 13:30 hr
OrganisationEMA
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