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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
    09:00 – 10:00 CEST
    Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe? (Part 1)
    Location: Pearl 1
    Moderator & Presenter: Rebecca Lumsden, PhD – Sanofi
    Presenter: Francesca A. Day, PhD – European Medicines Agency
    Presenter: Julie Spony, MA – European Patients' Forum
    Presenter: Laetitia Szaller, MA – AM-Pharma
    Presenter: Fabio Datri, PhD – European Commission
    PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Regulatory Strategy Development
    Supported by 
  • Thursday, May 11th
    10:30 – 11:30 CEST
    IMDRF- latest developments and future perspectives
    Location: Carmine & Charcoal
    Moderator & Presenter: Philippe M. Auclair, Mr – Abbott
    IVDRDomain: Regulatory Frameworks & StrategyKnowledge Area: General
    Supported By
  • Thursday, May 11th
    10:30 – 11:30 CEST
    Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe?(Part 2 )
    Location: Pearl 1
    Moderator & Presenter: Rebecca Lumsden, PhD – Sanofi
    Presenter: Francesca A. Day, PhD – European Medicines Agency
    Presenter: Julie Spony, MA – European Patients' Forum
    Presenter: Fabio Datri, PhD – European Commission
    PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Regulatory Strategy Development
    Supported By
  • 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
    13:45 – 14:45 CEST
    CDx or Not CDx, That is The Question - The Impact of the Clinical Trial Regulation on Tests Used in Pharma Studies and Whether and How the IVDR Applies
    Location: Pearl 3
    Moderator & Presenter: Sue Spencer – Qserve group
    Presenter: Ed Godber, n/a – Guardant Health
    Presenter: Patrick Fivey – AstraZeneca
    IVDDomain: Regulatory Frameworks & StrategyKnowledge Area: Regulatory Strategy Development
    Supported By
  • Thursday, May 11th
    15:00 – 16:00 CEST
    IVDR – what are the implications for in-house in vitro devices for stakeholders and practical steps for implementation
    Location: Carmine & Charcoal
    Moderator & Presenter: Elisabeth Dequeker, n/a – Prof
    Presenter: Tiina Riihimäki, PhD – Pharmalex Nordics
    IVDDomain: Regulatory Frameworks & StrategyKnowledge Area: General
    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
    Regulation Changes: Incentives for Pediatric Medical Devices in the US and Japan. Implications for the EU.
    Location: Pearl 3
    Presenter: Stephanie Huebner, MSc, PhD – Olympus Surgical Technologies Europe
    Medical DevicesDomain: Regulatory Frameworks & StrategyKnowledge Area: Market Strategy
    Supported By
  • Friday, May 12th
    10:45 – 11:45 CEST
    EMA's PRIME Scheme in Review: Findings, Lessons Learnt and Future Directions
    Location: Pearl 2
    Moderator & Presenter: Kevin Cunningham, PhD – European Medicines Agency
    Presenter: Els Caenen, PharmD – Janssen Pharmaceutical Companies of Johnson & Johnson
    Presenter: Nadege Le Roux – Bristol-Myers Squibb
    Presenter: Francesca Cerreta
    Presenter: Ilona Reischl, PhD – Austrian Medicines Agency, AGES MEA
    PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Market Strategy
    Supported By
  • Friday, May 12th
    12:00 – 13:00 CEST
    Real World Evidence...What Could Possibly go Wrong? A Clinician's Perspective
    Location: Pearl 2
    Moderator: Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group
    Presenter: Sophie Tabutin, PharmD, MSc – W.L. Gore & Associates
    Presenter: Gavin Quigley, MBChB FRCS MBA – BSI
    Presenter: Joshua Bridgens, MBBS FRCS – DePuy Synthes (J&J)
    Medical DevicesDomain: Regulatory Frameworks & StrategyKnowledge Area: Data Management & Analysis
    Supported By
  • Friday, May 12th
    12:00 – 13:00 CEST
    Research Use Only (RUO): What does this mean for legacy devices and product development of new in vitro diagnostics under the IVDR?
    Location: Pearl 1
    Moderator & Presenter: Ashleigh C. Dawley, RAC – Integrated DNA Technologies, Inc., a Danaher Company
    Presenter: Melissa Finocchio – SOPHiA GENETICS
    Presenter: Alex Laan, Dipl.-Ing. – BSI
    IVDDomain: Regulatory Frameworks & StrategyKnowledge Area: Regulatory Strategy Development
    Supported By
  • Friday, May 12th
    15:30 – 16:30 CEST
    Closing Panel: Impact of MDCG 2022-14 Position Paper on NB Capacity Since Publication
    Location: Pearl 1
    Moderator: Robert A. van Boxtel – Medical Device Project B.V.
    Presenter: Kevin Madden – BSI Group
    Presenter: Martin Witte – TÜV SÜD Product Service GmbH
    Presenter: Paul Kosters, PhD – DEKRA Certification BV
    Medical DevicesDomain: Regulatory Frameworks & StrategyKnowledge Area: Data Management & Analysis
    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