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Thursday, February 7 • 10:45 - 11:45
#S0106: Regulatory Data Use and Integrity across Stakeholders

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Component Type: Session

• 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


Co-Chairs
Peter Bachmann
Christa Wirthumer Hoche

Speaker

EMA’s Telematics Strategy/SPOR 
Niels Buch Leander, PhD

The Importance of Data Modelling for Successful Regulatory Affairs Units
Joerg Stueben, DrSc

Regulator Data Exchange Projects within EU
Laurent Desqueper



Speakers
avatar for Peter Bachmann

Peter Bachmann

Deputy-Head, European Union and International Affairs, Federal Institute for Drugs and Medical Devices (BfArM)
Peter Bachmann, PhD, chairs the Coordination Group for Mutual Recognition and Decentralised Procedures – human, and is a Member of the Scientific Coordination Board of the European Medicines Agency. He is also Head of the Unit of European Coordination and Deputy-Head of the Division... Read More →
avatar for Laurent Desqueper

Laurent Desqueper

XEVMPD-IDMP Regional Business Lead, MSD Europe
Laurent Desqueper is Business Lead for XEVMPD/IDMP Digital Transformation in the Regulatory Affairs Operations department at MSD Europe, Brussels, Belgium. After 10 years of IT projects and consultancy, Laurent transitioned to Business Regulatory Pharma topics by working for the European... Read More →
avatar for Niels Leander

Niels Leander

Consulting Director, NNIT
Dr. Niels Buch Leander is a Consulting Director and lead for Regulatory Affairs at NNIT, a global IT service provider to the pharmaceutical industry. Dr. Leander has 10 years of R&D IT project experience with eCTD, eTMF, EDMS, RIMS, xEVMPD and ISO IDMP and hence extensive experience... Read More →
avatar for Joerg Stueben

Joerg Stueben

Head of Regulatory Information Management, Boehringer Ingelheim International Gmbh
Dr Joerg Stueben works as “Head of Regulatory Information Management and Senior Expert” for Boehringer Ingelheim. He oversees all typical activities of a RIM group with a focus on Data Management incl modelling, IDMP/SPOR and Data Quality questions and on exploring AI and new... Read More →
avatar for Christa Wirthumer-Hoche

Christa Wirthumer-Hoche

Chair, EMA Management Board, Head, Austrian Medicines and Medical Devices Agency
Christa Wirthumer-Hoche studied biochemistry TU Vienna, doctoral thesis at Medical Physiology. Starting at the AT Nat. Inst. for Quality Control of Drugs - quality assessment, Head of Regulatory Affairs in the Ministry of Health, Now Head of the Austrian Medicines and Medical Devices... Read More →


Thursday February 7, 2019 10:45 - 11:45
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session