Sponsored Presentations - Exhibition Hall

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Tuesday, May 5th
08:30 - 16:00 WEST
Pre-Conference Workshop: Building Global CDx Studies: Strategic Planning Tools for IVD and Pharma Partners
Location: Pavilion 3 - Room 3A
Presenter: Natalie Batty, MPH – Immatics
Presenter: Marina Belonogova, PhD (she/her/hers) – Johnson & Johnson
Presenter: Carlos Galamba, MSc – MDx CRO
Presenter: Kristiane Schmidt, PhD (she/her/hers) – Qserve Consultancy
Pre-Conference WorkshopIVDs
Wednesday, May 6th
08:30 - 09:30 WEST
Transitional Timelines Unpacked: EU 2024/1860 and Its Impact on Legacy IVDs
Location: Pavilion 3
Speaker: Ellen van Loon, PhD (she/her/hers) – DEKRA Certification B.V.
Speaker: Guillaume Berger – GMED
Speaker: Alex Laan (he/him/his) – BSI
IVDs
Wednesday, May 6th
10:45 - 11:45 WEST
Building IVDR Technical Files: Early-Phase Insights and Strategic Approaches
Location: Auditorium 4
Speaker: Ellen van Loon, PhD (she/her/hers) – DEKRA Certification B.V.
Speaker: Ines Labugger, PhD (she/her/hers) – TÜV SÜD
IVDs
Wednesday, May 6th
12:00 - 13:00 WEST
Navigating Global CTR–IVDR Trials: Real-World Challenges and Practical Lessons
Location: Auditorium 3
Speaker: Carlos Galamba, MSc – MDx CRO
Speaker: Kirsten Van Garsse, RCC (she/her/hers) – QbD Group NV
Speaker: Audrey Toulemonde, MSc (she/her/hers) – Cencora
IVDs
Wednesday, May 6th
14:30 - 15:30 WEST
Mastering Risk Management for In-vitro Diagnostics Transitioning From Pre to Post Market - How Much Is Enough?
Location: Auditorium 4
Speaker: Sue Spencer – Compliance-Connextions Limited
Speaker: Caroline Alexander – Genedrive Diagnostics
Speaker: Sean O'Callaghan, BSc MSc – BSI
Speaker: Robyn Meurant, Medical Scientist – ACT-IVD
IVDs
Thursday, May 7th
08:30 - 09:30 WEST
The Unique Challenges of Managing Risks for IVDs Under ISO 14971:2019
Location: Auditorium 4
Speaker: Melissa Finocchio, ASQ CQE, ASQ CRE (she/her/hers) – Proud Lion Services
IVDs
Thursday, May 7th
10:45 - 11:45 WEST
Change Notification Process of IVD Devices Under the IVDR: Are You Ready?!
Location: Auditorium 4
Speaker: Alex Laan (he/him/his) – BSI
Speaker: Tom Patten – GMED
IVDs
Thursday, May 7th
12:00 - 13:00 WEST
First Time Right – Best Practices for Generation of High-quality Data in IVDR Performance Studies
Location: Auditorium 4
Speaker: Kristiane Schmidt, PhD (she/her/hers) – Qserve Consultancy
Speaker: James Kerr – BSI
Speaker: Erica Conway, BSc, PhD (she/her/hers) – GSK
Speaker: Luigi Cipolleschi, Dott. – Biochemical Systems International S.p.A.
IVDs
Thursday, May 7th
14:30 - 15:30 WEST
Novel Approaches for PMPF Surveys Under IVDR – Industry and Notified Body Perspectives
Location: Auditorium 4
Speaker: Margot J. Borgel, PhD – Astellas
Speaker: Bethany Chung, PhD, RAC – RQM+
Speaker: James Kerr – BSI
IVDs
Thursday, May 7th
16:45 - 17:45 WEST
PMS and PMPF Under IVDR: From Compliance Obligation to Continuous Performance Strategy
Location: Auditorium 4
Speaker: Goran Abdurrahman, PhD (he/him/his) – TÜV Rheinland
Speaker: Lisa Schälter, MSc (she/her/hers) – Consultys Medical GmbH
IVDs
Friday, May 8th
11:15 - 12:15 WEST
Performance Evaluation Under EU IVDR for Complex Diagnostics: Multiplex IVDs and Service-Based NGS Panels
Location: Auditorium 4
Speaker: Carlos Galamba, MSc – MDx CRO
Speaker: Javier Varela (he/him/his) – Pharmalex
IVDs
Friday, May 8th
12:30 - 13:30 WEST
Mastering EU in-house tests: Real-World Lessons From Laboratories Under the IVDR Article 5(5)
Location: Auditorium 4
Speaker: Andreas Oberleitner, MSc (he/him/his) – Platomics
Speaker: Natalie Batty, MPH – Immatics
Speaker: Marina Belonogova, PhD (she/her/hers) – Johnson & Johnson
IVDs