Protection of personal data and commercially confidential information (CCI) for documents uploaded and published in the Clinical Trials Information System (CTIS): Workshop on draft guidance
Table of contents
Date:
14/07/2022
Location:
Online, 10:00-17:00 Amsterdam time (CEST)
This workshop provides an opportunity for invited stakeholders to present their views on the draft guidance on protection of personal data and CCI for documents uploaded and published in the Clinical Trial Information System (CTIS), which is under open consultation until 8 September 2022.
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Event summary - Workshop on the guidance on the protection of personal data and commercially confidential information (CCI) in documents submitted or uploaded via CTIS (PDF/154.71 KB)
First published: 12/09/2022
EMA/652218/2022 -
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Presentation - Session 1.a: Key functionalities to protect personal data and CCI in CTIS (EMA) (PDF/474.81 KB)
First published: 12/09/2022 -
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Presentation - Session 1.b: Users’ feedback on CTIS use (C. Jacobs-Blom, EUCROF) (PDF/404.29 KB)
First published: 12/09/2022 -
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Presentation - Session 1.c: Protection of personal data and CCI for documents uploaded to CTIS (R.Pankow, ACRO) (PDF/208.56 KB)
First published: 12/09/2022 -
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Presentation - Session 1.d: EMA personal data CCI documents workshop (L.Liebers, EuropaBio) (PDF/342.87 KB)
First published: 12/09/2022 -
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Presentation - Session 1.e: Use of deferrals in CTIS, feedback from Member States (A.M. Janson Lang, Swedish MPA; S. Strasser, Austrian MPA) (PDF/556.3 KB)
First published: 12/09/2022 -
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Presentation - Session 2.a: Personal data protection principles governing CTIS (R.Popescu, EMA) (PDF/158.52 KB)
First published: 12/09/2022 -
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Presentation - Session 2.b: Protection of Personal Data and CCI for documents uploaded and published via CTIS (EuropaBio) (PDF/856.77 KB)
First published: 12/09/2022 -
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Presentation - Session 2.c: Protection of Personal Data and CCI for documents uploaded and published via CTIS (ACRO) (PDF/170.58 KB)
First published: 12/09/2022 -
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Presentation - Session 3.a: Main principles for commercially confidential information (CCI) in the Clinical Trial Information System (CTIS) (EMA) (PDF/226.4 KB)
First published: 12/09/2022 -
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Presentation - Session 3.b: Protection of Personal Data and CCI for documents uploaded and published via CTIS (EuropaBio) (PDF/391.34 KB)
First published: 12/09/2022