Medical Devices Track

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Monday, May 6th
08:30 – 16:00 CEST
Pre-Conference Workshop: EUDAMED
Location: B 07 + B 08
Workshop Leader: Jayanth K. Katta, PhD – BSI
Presenter: Christoph Kiesselbach – Schrack & Partner
Presenter: Sally Humphreys, DPhil – BSI
Presenter: Marina Madokoro – Johnson & Johnson MedTech
Medical Devices
Monday, May 6th
08:30 – 16:00 CEST
Pre-Conference Workshop: What Does it Take From CE to MDSAP?
Location: A 03
Workshop Leader: Corinne Delorme, RAC – nexialist
Presenter: Vincent Castéras, PhD – nexialist
Presenter: Szymon Kurdyn – DQS Medizinprodukte GmbH
Presenter: Maxim Shkolnikov – TÜV NORD CERT
Medical Devices
Tuesday, May 7th
08:30 – 09:30 CEST
Biocompatibility: Substances of Concern – Have You Checked? GSPR 10.4 a Practical Guide
Location: A 03 + A 04
Moderator: Barbara Leukers, RAC – RAPS Germany
Presenter: David John Mandley, PhD – NAMSA
Presenter: Juliane Kuhtz, Dr – Fresenius Kabi Deutschland GmbH
Presenter: Christina Reufsteck, PhD – TÜV SÜD Medical & Health Services
Medical Devices
Tuesday, May 7th
08:30 – 09:30 CEST
Kick-off MDR Panel
Location: C 01
Moderator: Gert W. Bos, Chairman of the Board and former president RAPS – QServe Group B.V.
Moderator: Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service
Panelist: Thierry Sirdey – CAMD
Panelist: Flora Giorgio – European Commission
Panelist: Royth P. von Hahn, PhD – TUV SUD Product Services
Medical Devices
Tuesday, May 7th
09:50 – 10:50 CEST
Clinical Evaluation: Unifying Clinical Evaluation Requirements: Exploring ISO 18969 and the "New MEDDEV 2.7/1"
Location: B 07 + B 08
Moderator & Presenter: Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Presenter: Danielle Giroud, MSci, MBA – MD-CLINICALS SA
Presenter: Rachel Mead, BEng MIET – BSI
Presenter: Paul Piscoi – European Commission - Directorate-General for Health and Food Safety
Medical Devices
Tuesday, May 7th
11:30 – 12:30 CEST
UK MDR: Current State of Play and Future Perspectives
Location: A 05 + A 06
Moderator: Giovanni Di Rienzo – Edwards Lifesciences
Presenter: Monisha Phillips, PhD – TUV SUD
Presenter: Vishal Thakker, MEng – BSI
Presenter: Joseph Burt
Medical Devices
Tuesday, May 7th
13:45 – 14:45 CEST
Finding Value in Post Market Clinical Data Collection
Location: C 01
Session Leader/Speaker: Bianca Lutters – QServe Group
Presenter: Caroline Ryan, PhD – Teleflex Medical
Presenter: Kelly van der Geest-Aspers, MSc – Erasmus MC
Medical Devices
Tuesday, May 7th
13:45 – 14:45 CEST
The Future of Standardization in Medtech and Its Impact on Your Regulatory Compliance
Location: B 09
Session Leader/Speaker: Sarah Panten – Medical Device Knowledge Unit (MDKU) e.V. / avasis solutions GmbH
Presenter: Sven Bergander, n/a – DIN Media (formerly Beuth Verlag)
Presenter: Sebastian Kriegsmann, n/a – DIN e.V.
Medical Devices
Tuesday, May 7th
15:05 – 16:05 CEST
Post-Market requirements: Keeping PSUR and SSCP up to Date
Location: B 09
Moderator: Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Presenter: Delphine Corriette Islanio, M Eng – W. L Gore & Associates
Presenter: Elizabeth Gfoeller, MA – MED-EL
Presenter: Markus Pöttker – Smith+Nephew
Medical Devices
Tuesday, May 7th
15:05 – 16:05 CEST
Use of Real World Evidence for Regulatory Making for Medical Devices and Diagnostics in EU: A Practical Guide
Location: C 01
Session Leader/Speaker: Richard G. Holborow, MSCST RCCP – Notified Body (BSI)
Presenter: Estelle Frappe – Aetion
Panelist: Tom Melvin, MB, BCh, BAO, LRCPI & SI, BCL LLM (NUI) – Trinity College Dublin
Panelist: Richard Dujmovic, MSEM – Boston Scientific
Medical Devices
Tuesday, May 7th
16:45 – 17:45 CEST
EMA Scientific Advice for High-Risk Devices – What We Know So Far
Location: B 05 + B 06
Moderator: Giovanni Di Rienzo – Edwards Lifesciences
Presenter: Rebecca Sheridan – Oxford Endovascular Ltd
Presenter: Alberto Ganan, PhD – European Medicines Agency
Medical Devices
Tuesday, May 7th
16:45 – 17:45 CEST
Pre-Clinical Evaluations and Clinical Investigations. Strategizing Towards Efficiency and New Approaches Including in Silico Methods
Location: C 01
Presenter: Jorn van Binsbergen, MSc – Qserve
Presenter: Charlott Danielson, M.Sc. – Fraunhofer IMTE
Medical Devices
Wednesday, May 8th
10:25 – 11:25 CEST
Collaboration Works: Risk Management – Clinical Evaluation – PMS/PMCF United
Location: B 05 + B 06
Moderator: Robert A. van Boxtel, MSc – Medical Device Project B.V.
Presenter: Alexej Agibalow – Escentia GmbH
Presenter: Markus Pöttker – Smith+Nephew
Presenter: Sarah Panten – Medical Device Knowledge Unit (MDKU) e.V. / avasis solutions GmbH
Medical Devices
Wednesday, May 8th
10:25 – 11:25 CEST
The Paradigm Shift in the EU Market Approval of Devices and IVDs – a Hot Potato?!
Location: C 01
Moderator: Gert W. Bos, Chairman of the Board and former president RAPS – QServe Group B.V.
Presenter: Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service
Presenter: Olga Van Grol-Lawlor, MPHIL – Boston Scientific
Presenter: Bianca Lutters – QServe Group
Presenter: Erik R. Vollebregt, LLM – Axon Lawyers
Medical Devices
Wednesday, May 8th
11:45 – 12:45 CEST
Clinical Evaluation: Complexity in Simplicity: Regulatory Challenges for Standard of Care Medical Devices
Location: C 01
Session Leader/Speaker: Milica Bajagic, PhD – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Presenter: Julia Rohrberg, PhD – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Presenter: Tina Richter, PhD – SLG Prüf- und Zertifizierungs GmbH
Presenter: Martin von Rüden, Dr. – QUESTALPHA GmbH & Co. KG
Medical Devices
Wednesday, May 8th
11:45 – 12:45 CEST
Environmental Regulation: How EU Green Deal and Other Environmental Regulations Affect Medical Devices and IVDs
Location: B 07 + B 08
Session Leader/Speaker: Erik R. Vollebregt, LLM – Axon Lawyers
Presenter: Jesús Rueda Rodríguez – MedTech Europe
Medical Devices
Wednesday, May 8th
14:00 – 15:00 CEST
IMDRF Coding: Complaints, Vigilance, Trend Analysis, and the Benefits of Codifying Your Post Market Surveillance System
Location: B 05 + B 06
Moderator: Robert A. van Boxtel, MSc – Medical Device Project B.V.
Presenter: Richard Bassett, Msc, LLM – DLRC
Presenter: Paul Riem Vis – Dutch Health and Youth Care Inspectorate
Medical Devices
Wednesday, May 8th
14:00 – 15:00 CEST
Post Market Clinical Studies
Location: C 01
Moderator & Presenter: Bianca Lutters – QServe Group
Presenter: Béatrice Lys
Presenter: Mara Chiaro, DVM – Corcym
Medical Devices
Wednesday, May 8th
15:40 – 16:40 CEST
Orphan Devices: How to Obtain Orphan or Pediatric Medical Device Approval
Location: B 07 + B 08
Moderator: Nataliya Deych
Presenter: Leo Hovestadt – Elekta
Presenter: Stephanie Huebner, MSc, PhD – Olympus Surgical Technologies Europe
Panelist: Kristina Larsson, MSc – European Medicines Agency
Medical Devices
Wednesday, May 8th
15:40 – 16:40 CEST
Structured Dialogue: Innovative Pathways in Europe and UK: A Legal, Manufacturer’s, and Notified Bodies Perspective
Location: B 05 + B 06
Presenter: Darren J. Thain – Smith+Nephew
Presenter: Alex Denoon – Bristows LLP
Presenter: Richard G. Holborow, MSCST RCCP – Notified Body (BSI)
Panelist: Alberto Ganan, PhD – European Medicines Agency
Medical Devices