Webinar for small and medium-sized enterprises (SMEs) and academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS)

• Date:
  Monday, 29 November 2021 , 09:00 - 13:30 Amsterdam time (CET)
• Location:
  Online
  European 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 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.

The event will start at 09:00 and finish at 13:30 Amsterdam time (CET).

A video recording is available.

Documents

Agenda - Webinar for SMEs and Academia on the Clinical Trial Regulation (Regulation (EU) No 536/2014) and the Clinical Trials Information System (CTIS)

Adopted Reference Number: EMA/323074/2021

Presentation - Transgene: Stakeholders’ experience with the Clinical Trials Regulation No 536/2014 implementation (Julien Romanetto)

Presentation - Access and user management, roles and permissions (A. Rodriguez Sanchez-Beato)

Presentation - High-level overview of CTIS, JCA and publication rules (Laura Pioppo)

Presentation - The new process for submitting clinical trials information in the EU-EEA (M. Elgaard Sørensen, DKMA & R. Pankow, Parexel International GmbH)

Video recording

Registration

• Registration closed.
• Only registered participants will be able to participate actively in the event.