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DISCLOSURE OF INFORMATION- WHAT WILL BE DISCLOSED ACCORDING TO THE NEW SCHEME IN THE CLINICAL TRIAL LEGISLATION?
Session Chair(s)
Alexander Roediger, MA, MBA
Executive Director EMEAC Oncology Policy
MSD Sharp and Dohme GmbH, Switzerland
The Clinical Trials Regulation requires that the EU database shall be publicly accessible unless, for all or part of the data and information contained therein, confidentiality is justified for certain reasons. Some factors that may justify confidentiality is the protection of commercially confidential information, the protection of confidential communication between Member States in relation to the preparation of the assessment report and the protection of personal data. This session will take a closer look at the circumstances under which “confidentiality is justified” as listed in Art. 81(4), in particular commercially confidential information. It will also address the questions what constitutes an “overriding public interest in disclosure” and which legitimate factors from various stakeholders need to be taken into account? Finally, it will put these requirements into the broader context, in particular regarding EMA’s Policy 70 “On publication of clinical data for medicinal products for human use”.
Speaker(s)
The Clinical Trials Regulation EU No 536/2014: provisions on transparency
Ana Rodriguez Sanchez Beato , PhD
European Medicines Agency, Netherlands
Head of Clinical and Non-Clinical Compliance, CTIS expert
Disclosing Information about Clinical Trials- Where are the limits? The Industry Research Perspective
Fabien Henri Gilbert Peuvrelle, PharmD, PhD
Celgene R&D SARL, Switzerland
Director, Knowledge Management - Reg Intelligence and Policy
Public Access to Clinical Trials Data: The consumer perspective
Ilaria Passarani, MSc
BEUC -The European Consumers' Organisation, Belgium
Head of the Health and Food Department
To What Extent will the European Citizen Benefit from the Clinical Trial Information? Experiences from Empirical Research
Frederic Bouder, PhD
University of Stavanger, Norway
Professor in Risk Management
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