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information (CCI) for documents uploaded and published in the Clinical Trials Information System (CTIS): Workshop on draft guidance

Event Human Clinical trials

The original event time is:
Thursday, July 14, 2022 - 10:00 - 17:00 Amsterdam time (CEST)

Date: Thursday, 14 July 2022 , 10:00 - 17:00 Amsterdam time (CEST)
Location: Online

European Medicines Agency, Amsterdam, the Netherlands

Event summary

This workshop provides an opportunity for invited stakeholders to present their views on the Draft guidance document on how to approach the protection of personal data and commercially confidential information in documents uploaded and published in the Clinical Trial Information System (CTIS) (CTIS), which is under open consultation until 8 September 2022.

Documents

Event summary - Workshop on the guidance on the protection of personal data and commercially confidential information (CCI) in documents submitted or uploaded via CTIS

Reference Number: EMA/652218/2022

English (EN) (154.71 KB - PDF)

First published: 12/09/2022

Presentation - Session 1.a: Key functionalities to protect personal data and CCI in CTIS (EMA)

English (EN) (474.81 KB - PDF)

First published: 12/09/2022

Presentation - Session 1.b: Users’ feedback on CTIS use (C. Jacobs-Blom, EUCROF)

English (EN) (404.29 KB - PDF)

First published: 12/09/2022

Presentation - Session 1.c: Protection of personal data and CCI for documents uploaded to CTIS (R.Pankow, ACRO)

English (EN) (208.56 KB - PDF)

First published: 12/09/2022

Presentation - Session 1.d: EMA personal data CCI documents workshop (L.Liebers, EuropaBio)

English (EN) (342.87 KB - PDF)

First published: 12/09/2022

Presentation - Session 1.e: Use of deferrals in CTIS, feedback from Member States (A.M. Janson Lang, Swedish MPA; S. Strasser, Austrian MPA)

English (EN) (556.3 KB - PDF)

First published: 12/09/2022

Presentation - Session 2.a: Personal data protection principles governing CTIS (R.Popescu, EMA)

English (EN) (158.52 KB - PDF)

First published: 12/09/2022

Presentation - Session 2.b: Protection of Personal Data and CCI for documents uploaded and published via CTIS (EuropaBio)

English (EN) (856.77 KB - PDF)

First published: 12/09/2022

Presentation - Session 2.c: Protection of Personal Data and CCI for documents uploaded and published via CTIS (ACRO)

English (EN) (170.58 KB - PDF)

First published: 12/09/2022

Presentation - Session 3.a: Main principles for commercially confidential information (CCI) in the Clinical Trial Information System (CTIS) (EMA)

English (EN) (226.4 KB - PDF)

First published: 12/09/2022

Presentation - Session 3.b: Protection of Personal Data and CCI for documents uploaded and published via CTIS (EuropaBio)

English (EN) (391.34 KB - PDF)

First published: 12/09/2022