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Preconference Workshops

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Preconference Workshops

All Preconference workshops require a separate registration fee and are not included in main conference pricing. Learn more:  https://www.raps.org/europe-2023/register

Preconference Workshops

  • Thursday, May 11th
    11:45 – 12:45 CEST
    Making full use of early access and regultatory tools available to ATMPs
    Location: Carmine & Charcoal
    Moderator: Jennifer Neff, PhD – Sartorius Stedim Biotech GmbH
    Presenter: Paulette Robinson, Ph.D, RAC – Neurogene
    Presenter: Caroline Pothet – European Medicines Agency
    PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Process & Procedures
    Supported By
  • Thursday, May 11th
    11:45 – 12:45 CEST
    Using TPLC and GMLP as Your Lighthouse, When Sailing Blind Among AI Icebergs
    Location: Pearl 1
    Moderator & Presenter: Catarina Carrão – BioSciPons
    Moderator & Presenter: Koen Cobbaert – Philips
    Medical DevicesDomain: Regulatory Frameworks & StrategyKnowledge Area: Process & Procedures
    Supported By
  • Thursday, May 11th
    15:00 – 16:00 CEST
    Regulatory policies and guidelines – are these enabling timely development of Orphan medicines globally?
    Location: Pearl 1
    Moderator & Presenter: Magdalena Bujar, BSc, MSc, PhD – CIRS
    Presenter: Martine Zimmermann, PharmD – Ipsen Innovation
    Presenter: Kristina Larsson, MSc – European Medicines Agency
    PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Process & Procedures
    Supported By
  • Thursday, May 11th
    16:45 – 17:45 CEST
    Conformity Assessment of Class D Devices: What is the Current Status?
    Location: Pearl 2
    Moderator: Maurizio Suppo, Dr. – Qarad
    Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
    Presenter: Catherine Holzmann – GMED Certification Division
    Presenter: Olga TKACHENKO, PhD – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
    Presenter: Elisabeth PhD Dequeker, PhD – University of Leuven
    Presenter: Richard J. Saunders, FIBMS – QuidelOrtho
    Presenter: Stefan Scheib, PhD – Roche Diagnostics GmbH
    Presenter: Heinrich Scheiblauer, Dr – Paul-Ehrlich-Institut
    IVDDomain: Product Development & RegistrationKnowledge Area: Process & Procedures
    Supported By
  • Friday, May 12th
    15:30 – 16:30 CEST
    MDCG22-14 Panel: Will IVDR Implementation Benefit From MDCG 2022-14 and if so, How ?
    Location: Pearl 2
    Moderator: Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service
    Moderator: Anja Wiersma, PhD – mi-CE consultancy
    Presenter: Andreas Stange – TUV SUD JAPAN LTD
    Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
    Presenter: Elizabeth Harrison, PhD – BSI Group
    Presenter: Liz Gommans, PhD – DEKRA Certification B.V.
    Presenter: Tom Patten – NSAI
    IVDDomain: Regulatory Frameworks & StrategyKnowledge Area: Process & Procedures
    Supported By