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Tuesday, May 13th
08:30 - 16:00 CEST
Preconference Workshop: From Concept to Compliance: Overcoming the Regulatory Challenges of Clinical Performance Studies
Location: Studio 204 (level 2)
Speaker: Natalie Batty, MPH – Aignostics
Speaker: Marina Belonogova, PhD (she/her/hers) – Johnson and Johnson
Speaker: Kristiane Schmidt, PhD (she/her/hers) – Qserve Consultancy BV
Speaker: Carlos Galamba – MDx CRO
IVDs
Tuesday, May 13th
08:30 - 16:00 CEST
Preconference Workshop: IVDR Technical Documentation
Location: Studio 206 (level 2)
Workshop Leader: Francesca Bevilacqua, PhD (she/her/hers) – TÜV SÜD Italy
Speaker: Catherine Holzmann, PhD – GMED Certification Division
Speaker: Alex Laan, Dipl.-Ing. (he/him/his) – BSI
Speaker: Marco Caproni (he/him/his) – TUV SUD
Speaker: Guillaume Berger – GMED
IVDs
Wednesday, May 14th
08:30 - 09:30 CEST
America First – Europe Second? Defining Global Market Access Strategies for Start-ups and New Devices
Location: Studio 211 + 212 (level 2)
Moderator: Kristiane Schmidt, PhD (she/her/hers) – Qserve Consultancy BV
Speaker: Sue Spencer – Compliance Connextions Limited
Speaker: Pierre-Emmanuel Thiriet, Dr. (he/him/his) – Rea Diagnostics
Speaker: Diana Rosentul, PhD (she/her/hers) – Aiosyn
IVDs
Wednesday, May 14th
10:45 - 11:45 CEST
Addressing the Complexities of Using in Vitro Diagnostics (IVDs) in Global Clinical Trials
Location: Studio 214 + 216 (level 2)
Moderator & Presenter: Kirsten Van Garsse, RCC-IVDR (she/her/hers) – Qarad (Part of the QbD Group)
Speaker: Sara Van Wouwe, RCC-IVDR (she/her/hers) – Qarad (part of the QbD Group)
Speaker: Erica Conway, BSc, PhD (she/her/hers) – GSK
IVDs
Wednesday, May 14th
12:00 - 13:00 CEST
Mastering IVD Software Classification and Overcoming PMS Regulatory Compliance Challenges at the Interface of the IVDR and the AI Act
Location: Copper Hall (level 0)
Moderator & Presenter: Anca-Sarmiza Gültekin-Tigan, Dr / MSc (she/her/hers) – QUAREGIA GmbH
Speaker: Mohamed-Salah Garouachi, PharmD – Constency Healthcare
Speaker: Alexander Stock, PhD (he/him/his) – TÜV SÜD
IVDs
Wednesday, May 14th
14:30 - 15:30 CEST
The Road Ahead: Impact of EU 2024/1860 for MDR and IVDR – Insights from Notified Bodies and Industry
Location: Silver Hall (level 0)
Speaker: Margot Borgel, PhD – RQM+
Speaker: Edward Ball, CEng MIPEM (he/him/his) – RQM+
Speaker: Maddalena Pinsi, MSc – BSI
Speaker: Sara Fabi, MSc – BSI
IVDs
Thursday, May 15th
08:30 - 09:30 CEST
Large Panel Genomic Profiling and IVDR: Strategies for Manufacturers
Location: Studio 211 + 212 (level 2)
Moderator & Presenter: Annelies Rotthier, PhD – Qarad (part of the QbDGroup)
Speaker: James Kerr (he/him/his) – BSI
Speaker: Elisabeth PhD Dequeker, PhD – University of Leuven
Speaker: Divera Pronk
IVDs
Thursday, May 15th
10:45 - 11:45 CEST
Navigating IVDR: Performance Evaluation and Usability for Near-patient and Self-tests
Location: Silver Hall (level 0)
Speaker: Margot Borgel, PhD – RQM+
Speaker: Sara Peeters, PhD (she/her/hers) – QbD
Speaker: Sven Hoffmann, MSc (he/him/his) – Entourage GmbH
IVDs
Thursday, May 15th
12:00 - 13:00 CEST
Navigating Pitfalls in Clinical Performance Studies: CRO Insights on Sample Management and Ethical Considerations
Location: Studio 211 + 212 (level 2)
Session Leader/Speaker: Sven Hoffmann, MSc (he/him/his) – Entourage GmbH
Speaker: Jörg Hollidt, PhD – in.vent Diagnostica GmbH
IVDs
Thursday, May 15th
14:30 - 15:30 CEST
Navigating Mergers and Acquisitions: Transitioning Products from IVDD/MD to IVDR/MDR Compliance
Location: Studio 211 + 212 (level 2)
Speaker: Rachel Ryll, MBA, CQA, CMQ/OE (she/her/hers) – Reliance Quality & Regulatory Consulting
IVDs
Thursday, May 15th
16:45 - 17:45 CEST
Critical IVDR Milestones & EU Reference Laboratories… a Testing Time
Location: Copper Hall (level 0)
Moderator: Erica Conway, BSc, PhD (she/her/hers) – GSK
Speaker: Andreas Stange, PhD (he/him/his) – TÜV SÜD
Speaker: Goran Abdurrahman, PhD (he/him/his) – TÜV Rheinland
Speaker: Thomas McDonagh, MSc – Abbott Core Diagnostics
Speaker: Annelies Heemskerk, PhD (she/her/hers) – Dutch Health and Youthcare Inspectorate
IVDs
Friday, May 16th
10:30 - 11:30 CEST
Mastering Post-market Surveillance Under IVDR: From PMPF to PSUR
Location: Silver Hall (level 0)
Session Leader: Anja Wiersma, PhD (she/her/hers) – mi-CE consultancy
Speaker: Liz Gommans, PhD (she/her/hers) – DEKRA B.V.
Speaker: Goran Abdurrahman, PhD (he/him/his) – TÜV Rheinland
Speaker: Leo WJ Klomp – Health and Youth Care Inspectorate (IGJ), Ministry of Health
IVDs
Friday, May 16th
11:45 - 12:45 CEST
Involving European Reference Laboratories in the Conformity Assessment of Class D Ivd's: Operational Update After 6 Months
Location: Copper Hall (level 0)
Moderator: Kirsten Van Garsse, RCC-IVDR (she/her/hers) – Qarad (Part of the QbD Group)
Speaker: Alex Laan, Dipl.-Ing. (he/him/his) – BSI
Speaker: Jennifer Rosendahl, PhD. (she/her/hers) – RISE
Speaker: Angela Filomena, Dr (she/her/hers) – Paul-Ehrlich-Institut
Speaker: Katja Mierish – Tuv Rheinland
Panelist: Aisha Sauer – European Commission
IVDs