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Millennium Hotel London Mayfair

Dec 05, 2017 8:30 AM - Dec 06, 2017 6:30 PM

44 Grosvenor Square Mayfair, London, W1K 2HP, United Kingdom

Clinical Trial Regulation Conference

Session 8: Legal Considerations for Clinical Data Publication

Session Chair(s)

Merete  Joergensen, MBA, MSc

Merete Joergensen, MBA, MSc

Clinical Disclosure and Transparency Expert

Merete-J Consulting, 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)

Marie  Manley

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)

Aleksandar   Rusanov

Drawing the Boundaries of Data Disclosure in Clinical Trials – the EMA Perspective

Aleksandar Rusanov

European Medicines Agency, Netherlands

Legal Adviser

Karen  Quigley

Panel Discussion with Q&A

Karen Quigley

European Medicines Agency, Netherlands

Clinical Data Publication Manager

Anne-Sophie  Henry-Eude, PharmD

Panel Discussion with Q&A

Anne-Sophie Henry-Eude, PharmD

European Medicines Agency, Netherlands

Head of Documents Access and Publication Department

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