SME and academia Clinical Trials Information System (CTIS) two-part training webinar - Day 2
Table of contents
Date:
04/03/2021
Location:
Virtual event
This training webinar provides essential information on CTIS for micro, small and medium-sized enterprises (SMEs) and non-commercial (academic) sponsors. For more information on CTIS, see Clinical Trials Regulation.
This is the second day of a two-day webinar. It will cover:
- Submitting an initial trial application in CTIS
- Updating an initial trial application, including making substantial modifications and adding a Member State concerned
- Making non-substantial modifications
- Submitting trial results
Presentations are provided by EMA system experts, European Commission, and presenters from SME and academic institutions. These will be complemented by pre-recorded demonstrations of the system.
The first day of the webinar is on 22 February 2021. EMA advises participants to attend both days of this training webinar.
The webinar is free of charge for all attendees.
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Agenda - SME and Academia Clinical Trials Information System (CTIS) two-part training webinar (PDF/492.73 KB)
Adopted
First published: 19/01/2021
Last updated: 19/02/2021 -
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Speaker bios - SME and Academia Clinical Trials Information System (CTIS) two-part training webinar (PDF/262.7 KB)
First published: 18/02/2021
Last updated: 03/03/2021
EMA/102023/2021 -
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Answers to knowledge check in the post event survey - SME and Academia Clinical Trials Information System (CTIS) two-part training webinar (PDF/144.26 KB)
First published: 12/03/2021 -
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Presentation - Sponsor activities during the life cycle of a clinical trial: submission of notifications (Stéphanie Kromar) (PDF/254.01 KB)
First published: 03/03/2021 -
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Presentation - Submission of an initial Clinical Trial Application in CTIS – structure, data and documents of an initial application dossier (Laura Pioppo) (PDF/267.64 KB)
First published: 03/03/2021 -
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Presentation - Submission of trial results and layperson summary (Andrea Seidel Glätzer) (PDF/397.32 KB)
First published: 03/03/2021 -
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Presentation - Transparency publication of clinical trial information contained in CTIS (Laura Pioppo) (PDF/522.66 KB)
First published: 03/03/2021 -
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Presentation - Changes done to an application via NON SM and RFI responses (Laura Pioppo) (PDF/357.92 KB)
First published: 03/03/2021 -
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Presentation - Update of an initial application (Laura Pioppo) (PDF/223.07 KB)
First published: 03/03/2021 -
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Presentation - Work planning and management tools (Stéphanie Kromar) (PDF/420.83 KB)
First published: 03/03/2021