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  • Monday, May 6th
    08:30 – 16:00 CEST
    Pre-Conference Workshop: IVDR Technical Documentation
    Location: B 09
    Workshop Leader: Marta Carnielli, PharmD – TUV Sud GmbH
    Presenter: Catherine Holzmann, PhD – GMED
    Presenter: Alex Laan – BSI
    Presenter: Tom Patten, MSc – NBCG-Med - Notified Body Coordination Group
    IVDs
  • Tuesday, May 7th
    08:30 – 09:30 CEST
    The IVDR Clock is Ticking... But Should There be Alarm?
    Location: B 05 + B 06
    Presenter: Erica Conway, PhD – MCRA
    Panelist: Elizabeth Harrison – BSI
    Panelist: Petra Zoellner – MedTech Europe
    Panelist: Marta Carnielli, PharmD – TUV Sud GmbH
    Panelist: Ortwin Schulte – Federal Ministry of Health Germany
    Panelist: Olga Tkachenko, PhD – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
    IVDs
  • Tuesday, May 7th
    09:50 – 10:50 CEST
    Clinical Performance Studies Under IVDR
    Location: A 03 + A 04
    Presenter: Margot Borgel, PhD – RQM+
    Presenter: Maham Ansari, MS, RAC – Precision for Medicine
    IVDs
  • Tuesday, May 7th
    11:30 – 12:00 CEST
    UK Market: PMS and Vigilance Requirements for IVDs
    Location: B 05 + B 06
    Presenter: Christèle East – Namsa
    IVDs
  • Tuesday, May 7th
    12:00 – 12:30 CEST
    Usability and Human Factors Studies – Considerations During Pre-Market Submission, Similarities and Differences Between the US and Europe
    Location: B 05 + B 06
    Presenter: Taly Vider Cohen, BSc – Regulatory Affairs and IP Director
    IVDs
  • Tuesday, May 7th
    13:45 – 14:45 CEST
    IVDR Class D Devices – Latest Updates and Experience
    Location: A 03 + A 04
    Presenter: Stefan Burde, PhD – TÜV SÜD
    Presenter: Elizabeth Harrison – BSI
    Presenter: Stefan Scheib, PhD – Roche Diagnostics GmbH
    Presenter: Sara Fabi, MSc – BSI
    IVDs
  • Tuesday, May 7th
    15:05 – 16:05 CEST
    CDx or Not CDx, That is The Question – The Impact of The IVD Regulation on IVDs Used in Pharmaceutical Clinical Trials
    Location: B 07 + B 08
    Presenter: Natalie Batty, MPH, CCRA – Aignostics
    Presenter: Marina Belongova – J&J
    Presenter: Rachel O'Leary
    Presenter: Olga Tkachenko, PhD – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
    IVDs
  • Tuesday, May 7th
    16:45 – 17:45 CEST
    Don’t Get Orphaned: How To Be Novel in the IVDR Environment
    Location: A 03 + A 04
    Session Leader/Speaker: Alex Laan – BSI
    Presenter: Warren Jameson, Bsi, PhD, MTOPRA – NAMSA
    IVDs
  • Wednesday, May 8th
    10:25 – 11:25 CEST
    Tackling Regulatory Challenges in a Global Marketplace: Developing a Robust Performance Evaluation Strategy for IVDs
    Location: B 07 + B 08
    Session Leader/Speaker: Christie Hughes, MPH, MLS(ASCP), RCC-IVDR – Qserve Group
    IVDs
  • Wednesday, May 8th
    11:45 – 12:45 CEST
    Maintaining Compliance: IVDR Post-Certification Activities
    Location: B 09
    Presenter: James Kerr – BSI
    Presenter: Sophie Roques-Violin, PharmD – Immunotech SAS (Beckman Coulter)
    Presenter: Annelies Rotthier, PhD – Qarad
    IVDs
  • Wednesday, May 8th
    14:00 – 15:00 CEST
    Experience Gain From Implementing Article 5(5) of the IVDR in a Network of European Laboratories
    Location: B 09
    Session Leader/Speaker: Marta Montilla – Unilabs
    Presenter: Folker Spitzenberger, PhD, MDRA – Technische Hochschule Lübeck Fachbereich Angewandte Naturwissenschaften
    Presenter: Erik R. Vollebregt, LLM – Axon Lawyers
    Presenter: Ozan Aykurt, M.Sc. – Fraunhofer Research Institution for Individualized and Cell-Based Medical Engineering IMTE
    IVDs
  • Wednesday, May 8th
    15:40 – 16:40 CEST
    IVDR Track Closing Panel: What Are The Remaining Challenges for IVDR?
    Location: C 01
    Moderator: Alex Laan – BSI
    Presenter: Anja Wiersma, PhD – mi-CE consultancy
    Presenter: Elizabeth Harrison – BSI
    Presenter: Tom Patten, MSc – NBCG-Med - Notified Body Coordination Group
    Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
    Presenter: Olga Tkachenko, PhD – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
    IVDs