Webinar for small and medium-sized enterprises (SMEs) and academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS)
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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.
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Agenda - Webinar for SMEs and Academia on the Clinical Trial Regulation (Regulation (EU) No 536/2014) and the Clinical Trials Information System (CTIS) (PDF/228.69 KB)
Adopted
First published: 10/09/2021
Last updated: 25/11/2021
EMA/323074/2021 -
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Presentation - European Commission - Clinical Trial Regulation 536/2014: Objectives, key changes and transitional arrangements (Kristof Bonnarens) (PDF/806.3 KB)
First published: 25/11/2021 -
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Presentation - European Organisation for Research and Treatment of Cancer (EORTC): Stakeholders’ experience with the Clinical Trials Regulation No 536/2014 implementation (Stephanie Kromar) (PDF/1.19 MB)
First published: 25/11/2021 -
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Presentation - Medical Faculty and Heidelberg University Hospital: Stakeholders’ experience with the Clinical Trials Regulation No 536/2014 implementation (A. Seidel-Glatzer) (PDF/834.44 KB)
First published: 25/11/2021 -
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Presentation - Transgene: Stakeholders’ experience with the Clinical Trials Regulation No 536/2014 implementation (Julien Romanetto) (PDF/697.2 KB)
First published: 25/11/2021 -
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Presentation - Access and user management, roles and permissions (A. Rodriguez Sanchez-Beato) (PDF/543.68 KB)
First published: 25/11/2021 -
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Presentation - CTIS explained with user personas and organisation models (Sarah Scales) (PDF/298.43 KB)
First published: 25/11/2021 -
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Presentation - High-level overview of CTIS, JCA and publication rules (Laura Pioppo) (PDF/576.81 KB)
First published: 25/11/2021 -
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Presentation - The new process for submitting clinical trials information in the EU-EEA (M. Elgaard Sørensen, DKMA & R. Pankow, Parexel International GmbH) (PDF/688.48 KB)
First published: 25/11/2021 -
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Presentation - Safety reporting in CTIS (Marianne Lunzer, AGES) (PDF/1.05 MB)
First published: 25/11/2021 -
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Presentation - Overview of guidance and training available for sponsors (Fia Westerholm) (PDF/389.1 KB)
First published: 25/11/2021