Sponsored Presentations - Exhibition Hall

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Tuesday, May 5th
08:30 - 16:00 WEST
Pre-Conference Workshop: Driving Change: How to Successfully Implement AI and Digital Transformation in Regulatory Affairs (MD, Pharma, IVDR)
Location: Pavilion 5 - Room 5C
Workshop Leader: Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Speaker: Sarah Haake-Schäfer (she/her/hers) – Carl Zeiss Vision International GmbH
Speaker: Erika Schuettfort, PhD (she/her/hers) – Vorsa
Speaker: Frank Pétavy, MSc (he/him/his) – European Medicines Agency
Speaker: Emilie Santos, BSc. MSc. PhD (she/her/hers) – Philips Healthcare
Speaker: Julia Friedrich, PhD (she/her/hers) – Miltenyi Biotec B.V. & Co. KG
Speaker: Jean-Pierre Doan, MSc. MBA – Merck KGaA
Speaker: Paul Bolot, PharmD (he/him/his) – Bayer (on behalf of EFPIA)
Speaker: Yun-Hsuan Chang, MD MSc – Scarlet
Pre-Conference WorkshopDigital HealthPharmaceuticalsMedical Devices
Tuesday, May 5th
08:30 - 16:00 WEST
Pre-Conference Workshop: EUDAMED & swissdamed: Practical Steps to Implementation, Strategic and Future Insights
Location: Pavilion 3 - Room 3C
Workshop Leader: Marina Madokoro (she/her/hers) – Johnson & Johnson
Presenter: Christoph Kiesselbach (he/him/his) – Schrack & Partner
Presenter: Sofia Palm – BSI
Speaker: Susanne Wydenkeller Hinder, PhD – Swissmedic, Swiss Agency for Therapeutic Products
Speaker: Susan Partridge, PhD – BSI
Pre-Conference WorkshopMedical Devices
Tuesday, May 5th
08:30 - 16:00 WEST
Pre-Conference Workshop: Global Regulatory Pathways - US, China and South Korea
Location: Pavilion 5 - Room 5A
Workshop Leader: Chang-Hong Whitney, RAC, MBA – Whitney Consulting Ltd.
Presenter: M. Jason Brooke, MSE, JD, CSQE – Brooke & Associates
Presenter: Young Kim, MBA – Synex Consulting Ltd.
Pre-Conference WorkshopMedical Devices
Wednesday, May 6th
08:30 - 09:30 WEST
MDR 2.0: Kick-off Panel 2026
Location: Auditorium 1
Moderator: Gert W. Bos, PhD FRAPS (he/him/his) – QServe Group
Panelist: Elizabeth Gfoeller, MA – MED-EL
Panelist: Judite Neves, PharmD – INFARMED, I.P.
Panelist: Royth P. von Hahn, PhD (he/him/his) – TÜV SÜD Product Services
Panelist: Kelly van der Geest-Aspers, MSc (she/her/hers) – Erasmus MC
Panelist: Flora Giorgio (she/her/hers) – European Commission
Medical Devices
Wednesday, May 6th
08:30 - 09:30 WEST
QMSR: Navigating the New FDA Quality Management System Regulation (QMSR): Regulatory Insights and Compliance Strategies
Location: Auditorium 3
Moderator: Frederike Bruehschwein, MA (she/her/hers) – regular services
Speaker: Seb Clerkin, PhD RAC (EU) – GMP Advisory Services
Speaker: Keisha Thomas – The U.S Food and Drug Administration
Medical Devices
Wednesday, May 6th
10:45 - 11:45 WEST
Simplification and Centralization
Location: Auditorium 1
Moderator: Gert W. Bos, PhD FRAPS (he/him/his) – QServe Group
Panelist: Joao Martins, PharmD – Abbott
Panelist: Sebastian Fischer – TÜV SÜD Product Service
Panelist: Flora Giorgio (she/her/hers) – European Commission
Medical Devices
Wednesday, May 6th
10:45 - 11:45 WEST
Singing in Harmony: Leveraging MDSAP to Synergize your QMS
Location: Pavilion 3
Speaker: Grace F. Palma, MBA (she/her/hers) – China Med Device
Speaker: Ed Ball, CEng MIPEM (he/him/his) – RQM+
Speaker: Linda Moon, MPhil., BSc.(Hons). (she/her/hers) – BSI
Medical Devices
Wednesday, May 6th
12:00 - 13:00 WEST
Clinical Evidence beyond Clinical Data, a practical approach considering current legislation and future outlook
Location: Pavilion 3
Speaker: Natascha J. Cuper – Kiwa Assurance
Speaker: Leon J. Doorn, M.Sc. (he/him/his) – MedQAIR
Medical Devices
Wednesday, May 6th
12:00 - 13:00 WEST
RIM: Building Strong Business Regulatory Processes Around a Regulatory Information Management (RIM) System – a Scenario for Medical Devices
Location: Auditorium 2
Speaker: Sanja Matern, PhD, RAC Devices (she/her/hers) – Fresenius Medical Care Deutschland GmbH
Speaker: Mandy Blocher (she/her/hers) – Aesculap AG
Speaker: Kirsten Eickhoff (she/her/hers) – HOYA SURGICAL OPTICS
Medical Devices
Wednesday, May 6th
14:30 - 15:30 WEST
Clinical Evidence as the Cornerstone of MDR Compliance: Lessons, Challenges, and the Road Ahead
Location: Auditorium 2
Moderator: Gert W. Bos, PhD FRAPS (he/him/his) – QServe Group
Speaker: Marianna Mastroroberto, NB 0476 – Kiwa Cermet Italia
Speaker: Wouter Mattheussens – QServe Group
Speaker: Roberto Camillini – CEROM (IT) - https://www.irst.emr.it/it/ricerca-e-innovazione/comitato-etico-della-romagna
Medical Devices
Wednesday, May 6th
14:30 - 15:30 WEST
The Mystic Neighbour: Notified Body Oversight with a Watch on SOTA, Risk, PMS, and Claims
Location: Pavilion 3
Moderator: Robert A. van Boxtel, MSc – Medical Device Project B.V.
Speaker: Markus Pöttker (he/him/his) – Smith+Nephew
Speaker: Sarah Panten, Dipl.-Ing. – avasis solutions GmbH / Medical Device Knowledge Unit e.V.
Speaker: Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Speaker: Natascha J. Cuper – Kiwa Assurance
Medical Devices
Thursday, May 7th
08:30 - 09:30 WEST
PSUR: The Power of One: Aligning PSURs Across EU, GB and Canada
Location: Auditorium 1
Speaker: Claudia Möller, M.Sc. (she/her/hers) – Metecon GmbH
Speaker: Markus Pöttker (he/him/his) – Smith+Nephew
Speaker: Breda Kearney, BSc, MSc – BSI
Medical Devices
Thursday, May 7th
10:45 - 11:45 WEST
Health Technology Assessment (HTA)
Location: Pavilion 3
Speaker: Thomas Miramond – NAMSA
Speaker: Leslie Hammermueller (she/her/hers) – AKRA Team GmbH
Speaker: Helena Monteiro – INFARMED – National Authority of Medicines and Health Products, I.P.
Medical Devices
Thursday, May 7th
10:45 - 11:45 WEST
SOTA: Breaking the Chicken-Egg Loop
Location: Auditorium 1
Speaker: Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Speaker: Elke Bess, PhD (she/her/hers) – TÜV Rheinland LGA Products GmbH, Notified Body 0197
Speaker: Julia Rohrberg – Heraeus Medical GmbH
Medical Devices
Thursday, May 7th
12:00 - 13:00 WEST
In Silico: Virtual Patients, Real Evidence: The Current Use of In Silico Regulatory Evidence
Location: Pavilion 3
Speaker: Grit Kasper, PhD (she/her/hers) – Metecon GmbH
Speaker: Surash Surash, FRCS (Neuro.Surg), MD, LLM – TUV SUD
Speaker: Philippe Favre, PhD (he/him/his) – Zimmer Biomet
Speaker: Okan Avci, Dr (he/him/his) – Fraunhofer IPA
Medical Devices
Thursday, May 7th
12:00 - 13:00 WEST
Orphan Devices - Finding Rarity: A Case Study in Achieving Orphan Device Designation in the EU
Location: Auditorium 2
Moderator: Suzanne Halliday, DPhil, FRAPS – BSI
Speaker: Sandra Thiollière, MSc (she/her/hers) – Carthera
Speaker: Estelle Douceron, PhD (she/her/hers) – RQM+
Speaker: Silvy Da Rocha Dias – European Medicines Agency
Speaker: Richard G. Holborow, n.a. (he/him/his) – BSI
Medical Devices
Thursday, May 7th
14:30 - 15:30 WEST
Environmental Convergence: Horizontal EU Requirements Reshaping Medical Device and IVD Regulation
Location: Auditorium 1
Moderator: Suzanne Halliday, DPhil, FRAPS – BSI
Speaker: Erik R. Vollebregt – Axon Lawyers
Speaker: Darren J. Thain, RCC – Smith+Nephew
Medical Devices
Thursday, May 7th
14:30 - 15:30 WEST
UK Regulations
Location: Auditorium 2
Moderator: Gert W. Bos, PhD FRAPS (he/him/his) – QServe Group
Speaker: Vishal Thakker, n/a (he/him/his) – BSI
Speaker: Ashleigh Batchen (she/her/hers) – TÜV SÜD
Speaker: Dennis Sarwin, MSc – Qserve Group
Speaker: Nadine Neale, PGDip (she/her/hers) – MHRA
Medical Devices
Thursday, May 7th
16:45 - 17:45 WEST
Custom-made and other Personalized Medical Devices: International Regulatory Requirements
Location: Pavilion 3
Moderator: Suzanne Halliday, DPhil, FRAPS – BSI
Speaker: Sophie Tabutin, PharmD, MSc (she/her/hers) – W. L. Gore & Associates
Speaker: Maddalena Pinsi, MSc – BSI Notified Body
Speaker: Heitor M A Korndorfer – MSC MED ENGENHARIA E TECNOLOGIA MEDICA
Medical Devices
Thursday, May 7th
16:45 - 17:45 WEST
Navigating the Challenges of Medical AI Usability
Location: Auditorium 2
Speaker: Mariana de Oliveira, MSc – University of Lisbon, Faculty of Sciences
Speaker: Jonathan Kendler, MSc (he/him/his) – Curiolis, Inc.
Speaker: Mafalda Carvalho – North Lisbon University Hospital Centre (ULS Santa Maria)
Speaker: Ana Burman, PhD (she/her/hers) – Flok Health
Medical Devices
Friday, May 8th
11:15 - 12:15 WEST
Biocompatibility in Transition – Integrating Biological Safety, Post-Market Evidence, and Advanced Risk Assessment
Location: Auditorium 2
Moderator: Gert W. Bos, PhD FRAPS (he/him/his) – QServe Group
Speaker: Michelle Kelly, ERT (she/her/hers) – NAMSA
Speaker: Patrícia da Silva Pérez, PhD – Qserve Group
Speaker: Petr Bratka, PhD (he/him/his) – Centre for Medical Devices Certification, Czech Metrology Institute
Medical Devices
Friday, May 8th
11:15 - 12:15 WEST
International Reliance: Medical Devices in the Tropics: Tips, Tricks and Odds for Your ANVISA Submission
Location: Auditorium 1
Speaker: Bruno J S Oliveira, Sr., MSc (he/him/his) – MSC MED Engenharia e Tecnologia Médica Ltda.
Speaker: Dennis Sarwin, MSc – Qserve Group
Speaker: Nada Alkhayat – European Commission
Medical Devices
Friday, May 8th
12:30 - 13:30 WEST
AI-Powered Conformity Assessment: Transforming Notified Body Operations
Location: Pavilion 3
Speaker: Erik R. Vollebregt – Axon Lawyers
Speaker: Tom Patten – GMED
Speaker: Sebastian Fischer – TÜV SÜD Product Service
Medical Devices
Friday, May 8th
12:30 - 13:30 WEST
Falsified Medical Devices & Certificates
Location: Auditorium 2
Speaker: Jean McKenzie, MSc – DEKRA Certification B.V.
Speaker: Theodora Michael Mathioudaki, MSc – Smith+Nephew
Medical Devices