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Session 8: Legal Considerations for Clinical Data Publication
Session Chair(s)
Merete Joergensen, MBA, MSc
Clinical Disclosure and Transparency Expert, Former EFPIA, CREG Clinical Trials
Merete-J Consulting CVR: 34920818, Denmark
Publication of Clinical Documents requires a lot of considerations about legal aspects, about Private Personal Data, Company Confidential Information, Copy Rights, and Terms of use of the information made available. Presentations will cover an overview of the different legislation requirements, as they are applicable to the release of documents as specified in EMA's Policy 0070 on proactive data sharing, and on Policy 0043 on Requested Data Access. Views from the aspect of industry as well as from the regulatory authority perspective will be presented.
Speaker(s)
Drawing the Boundaries of Data Disclosure in Clinical Trials – the Industry Perspective
Marie Manley
Sidley Austin LLP, United Kingdom
Partner, Head of EU and UK Life Sciences (UK)
Drawing the Boundaries of Data Disclosure in Clinical Trials – the EMA Perspective
Aleksandar Rusanov
European Medicines Agency, Netherlands
Legal Adviser
Panel Discussion with Q&A
Karen Quigley
European Medicines Agency, Netherlands
Clinical Data Publication Manager
Panel Discussion with Q&A
Anne-Sophie Henry-Eude, PharmD
European Medicines Agency, Netherlands
Head of Documents Access and Publication Department