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Regulatory Data Use and Integrity across Stakeholders
Session Chair(s)
Peter Bachmann
Deputy-Head, European Union and International Affairs
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Christa Wirthumer-Hoche, PhD
Chair, EMA Management Board, Head
Austrian Medicines & Medical Devices Agency (AGES), Austria
• Electronic optimisation and recent regulatory updates (e.g. SPOR, IRIS, Telematics strategy) • Ensure data use efficiencies and integrity across stakeholders • Technological advancements in regulatory systems
Speaker(s)
EMA’s Telematics Strategy/SPOR
Niels Buch Leander, PhD
NNIT, Denmark
Associate Vice President, Global Head of Regulatory Affairs
The Importance of Data Modelling for Successful Regulatory Affairs Units
Joerg Stueben, DrSc
Boehringer Ingelheim International GmbH, Germany
Head of Regulatory Information Management
Regulator Data Exchange Projects within EU
Laurent Desqueper
-, Belgium
IDMP Business Data Lead
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