Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS
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Clinical Trials Information System (CTIS) will act as the single entry point for clinical trials authorisation and supervision in the EEA. CTIS was created as part of the EU Clinical Trials Regulation (Regulation (EU) No 536/2014).
This EMA hosted webinar is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations. Topics presented during the webinar include how sponsor organisations can prepare for CTIS, how Member States aim to support sponsor preparedness and adoption of CTIS, the role of the Clinical Trial Regulation and how sponsors can best make use of EMA’s CTIS training materials.
No certificates of attendance will be issued for this event. We encourage event participants to submit questions related to sponsor preparedness in advance of the webinar. The most popular questions submitted in advance of the event will be answered by speakers during the panel session. Please provide your questions by 20 July 2021.
A recording of this event is available below.
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Agenda - Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS (PDF/91.91 KB)
First published: 06/07/2021
Last updated: 27/07/2021
EMA/363108/2021 -
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Speakers - Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS (PDF/169.06 KB)
First published: 08/07/2021
Last updated: 27/07/2021
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Presentation - CTIS: harmonising the submission, authorisation and supervision of clinical trials (P. Vankeerberghen) (PDF/251.95 KB)
First published: 30/07/2021 -
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Presentation - CTIS personas and sponsor organisation modelling for sponsor preparedness (S. Scales) (PDF/257.78 KB)
First published: 30/07/2021
Last updated: 16/09/2021 -
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Presentation - EMA training and support for sponsors (F. Westerholm) (PDF/479.39 KB)
First published: 30/07/2021
Last updated: 16/09/2021 -
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Presentation - How Sponsor organisations can prepare for CTIS: Academia perspective (A. Seidel Glätzer) (PDF/429.74 KB)
First published: 30/07/2021 -
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Presentation - How sponsor organisations can prepare for CTIS: SME perspective (T. B. Moulvad) (PDF/510.08 KB)
First published: 30/07/2021 -
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Presentation - How sponsors are preparing for CTIS: Large sponsor perspective (R-M. Swallow) (PDF/261.51 KB)
First published: 30/07/2021 -
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Presentation - Member State support for sponsor preparedness and adoption (M. Elgaard) (PDF/854.69 KB)
First published: 30/07/2021 -
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Presentation - Clinical Trials Regulation: why, when, what and how? (S. Giraud) (PDF/352.66 KB)
First published: 30/07/2021 -
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Presentation - What is needed to work in CTIS: Organisation , Admin and User Registration (A. Rodriguez) (PDF/879.8 KB)
First published: 30/07/2021
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