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The origins and objectives of European regulations for medical devices
Time: 1h15


17h00 - 17h05: Introduction by the moderator: Ass. Prof. Per Kjaersgaard-Andersen

17h05 - 17h20: The history of regulation for devices in Europe , Alan Fraser, European Society of Cardiology

17h20 - 17h35: The emerging discipline of “regulatory science”
Tom Melvin, Trinity College Dublin

17h35 - 18h10 Discussion:
What are the needs of the regulators? Paul Piscoi, European Commission DG SANTE
How can clinicians contribute? Rob Nelissen, Leiden, Expamed and CORE-MD

18h10 - 18h15: Concluding remarks
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