Full Schedule

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Wednesday, May 8, 2024
07:30 – 15:30 CEST
Speaker Ready Room Open (B04)
Location: B 04
07:30 – 16:00 CEST
Registration (A Level)
Location: A Level
07:30 – 05:30 CEST
Cloakroom (A level)
Location: A 08
08:30 – 09:45 CEST
Conversations That Matter: Interactions with Health Authorities
Location: C 01
Moderator: Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service
Moderator: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
Panelist: Alberto Ganan, PhD – European Medicines Agency
Panelist: Christelle Bouygues, PharmD – EMA
Panelist: Suzanne Halliday – BSI
Panelist: Thierry Sirdey – CAMD
Panelist: Constantinos Ziogas, MD – European Medicines Agency
Panelist: Flora Giorgio – European Commission
Panelist: Olga Tkachenko, PhD – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
09:45 – 10:25 CEST
Coffee Break in the Exhibit Hall on All Levels
Location: All Levels
09:45 – 10:25 CEST
Presenters at Posters (C Level)
Location: C Level
Posters - Click to View
09:45 – 15:45 CEST
Exhibition Open
Location: Levels A and B
10:25 – 11:25 CEST
Application of Article 61(10), Non-Clinical Data, for SaMD and AI
Location: B 09
Session Leader/Speaker: Natascha J. Cuper, PhD – Kiwa Dare
Presenter: Vincent van der Meer – Medical Device Project B.V.
AI/Software
10:25 – 11:25 CEST
Career Development: Live LinkedIn Review Session
Location: A 03 + A 04
Presenter: Elena Kyria – Elemed
Regulatory Business
10:25 – 11:25 CEST
CTA with Devices: State of Play for Non-CE Marked Diagnostic Tests in European Clinical Trials
Location: A 05 + A 06
Presenter: Pieter Bogaert, PhD – Qarad
Presenter: Sven Hoffmann, MSc – Entourage GmbH
Pharmaceuticals
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
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
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
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
11:45 – 12:45 CEST
Data Security and Digital Health: Medical Devices, IVDs and the Increasing EU Regulation of Health Data
Location: B 05 + B 06
Presenter: Cecile E. Van der Heijden – Axon Lawyers
Presenter: Leo Hovestadt – Elekta
AI/Software
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
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
11:45 – 12:45 CEST
Patient-Centric Endpoints and Use of Digital Health Technologies
Location: A 03 + A 04
Moderator: Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting
Presenter: Karl-Heinz Huemer – khhconsulting
Presenter: Anirban Sadhu – Teva Pharmaceuticals
Presenter: Adrienne Lenz, RAC – Hyman, Phelps & McNamara, P.C.
Pharmaceuticals
11:45 – 12:45 CEST
Supply Chain/Shortage
Location: A 05 + A 06
Presenter: Rachel Harte – CAI
Presenter: Sarbajit Chakrabarti, MTech, MSc – Parexel International India Safety Services Private Limited
Presenter: Siegfried Schmitt, PhD – Parexel
Presenter: Monica Dias, PhD – EMA
Pharmaceuticals
12:45 – 13:15 CEST
SESSION IS FULL Circle: Essentials of EU Regulatory Intelligence; Overview of Key Aspects of Regulatory Intelligence
Location: B 95
Presenter: Denis Burkhalter, MSc – Novartis
Solutions Circle - Ticket Required
12:45 – 13:15 CEST
Solutions Circle: Cyber Security – Pitfalls for IVDR Technical File Submission
Location: A 08
Presenter: Alexander Stock – TÜV SÜD
Solutions Circle - Ticket Required
12:45 – 13:15 CEST
Solutions Circle: How Does the SSCP Improve Patient Safety in Less Than 100 Pages?
Location: A 08
Presenter: Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Solutions Circle - Ticket Required
12:45 – 14:00 CEST
Chapter/Local Networking Group Meet and Greets (C Level)
Location: C Level
12:45 – 14:00 CEST
Networking Lunch in Exhibit Hall on All Levels
Location: All Levels
13:15 – 13:45 CEST
Sponsored Presentation: Consolidating Economic Operators for Market Access Globally
Location: A 03 + A 04
Presenter: Daniëlle Sleegers – MedEnvoy Global
Sponsored Presentation
Sponsored By
13:15 – 13:45 CEST
Sponsored Presentation: Navigating The Future - Insights From The 2024 State Of Medtech Report
Location: B 05 + B 06
Presenter: Eric Gaidis – Greenlight Guru
Sponsored Presentation
Sponsored By
13:15 – 13:45 CEST
Sponsored Presentation: Raising the Bar on Cybersecurity: Understanding New Regulations and How IEC 81001-5-1 Can Help Navigate
Location: B 07 + B 08
Presenter: Michelle Jump, RAC – MedSec LLC
Sponsored Presentation
Sponsored By
13:15 – 13:45 CEST
Sponsored Presentation: State of the art and the medical device lifecycle
Location: B 09
Presenter: Ed Ball, Msc, CEng – RQM+
Sponsored Presentation
Sponsored By
13:15 – 13:45 CEST
Sponsored Presentation: The Challenge of the Transition: A Practical Guide on How To Use Data Historicity To Produce Correct Rationales and Deal Effectively With the Transition From MDD to MDR
Location: A 05 + A 06
Presenter: Marianna Mastroroberto, MD – Kiwa
Sponsored Presentation
Sponsored By
13:15 – 13:45 CEST
Sponsored Presentation: The top gotchas when expanding your clinical development into the US
Location: C 01
Presenter: Gretchen Miller Bowker – Pearl Pathways
Sponsored Presentation
Sponsored By
13:30 – 14:00 CEST
Solutions Circle: Effective Strategies When Approaching Regulatory Due Diligence Under the MDR
Location: A 08
Presenter: Matt Royle, PhD – NAMSA
Solutions Circle - Ticket Required
13:30 – 14:00 CEST
Solutions Circle: Intended Purpose, Device Classification, NB Codes, and Corresponding Types of Devices/Sampling TD Under the IVDR
Location: A 08
Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
Solutions Circle - Ticket Required
13:30 – 14:00 CEST
Solutions Circle: Effective Strategies for High-Quality Clinical Data Collection Through Post-Market Clinical Follow-Up (PMCF) Surveys and Medical Device Registries
Location: B 95
Presenter: Catarina Carrão – BioSciPons
Presenter: Marcus Torr, MSci – Purdie Pascoe
Solutions Circle - Ticket Required
14:00 – 15:00 CEST
International Regulatory Frameworks to Accelerate Orphan Drug Registrations
Location: A 05 + A 06
Session Leader/Speaker: Merce Caturla Goni, PhD – Alexion Astra Zeneca Rare Diseases
Presenter: Kristina Larsson, MSc – European Medicines Agency
Presenter: Tomasz Grybek, MA – Foundation of Borys the Hero
Pharmaceuticals
14:00 – 15:00 CEST
Data at the Core: Understanding Your Company's Critical Yet Underutilized Tool
Location: A 03 + A 04
Moderator: Charlie Mortazavi, SANOFI – SANOFI
Presenter: James Cross, PhD – Asher Biotherapeutics, Inc.
Presenter: Deborah Bebbington – Bayer Plc
Presenter: Nathalie Gass, PhD – F. Hoffmann-La Roche Ltd
Pharmaceuticals
14:00 – 15:00 CEST
Cybersecurity: Integrating Medical Device Cybersecurity in the Quality Management System
Location: B 07 + B 08
Session Leader/Speaker: Gregg W. Van Citters, PhD – MEDIcept, Inc.
Presenter: Kimberly A. Trautman, MS – RAPS BoD
AI/Software
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
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
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
15:00 – 15:40 CEST
Coffee Break in the Exhibit Hall
Location: All Levels
15:00 – 15:40 CEST
Presenters at Posters (C Level)
Location: C Level
Posters - Click to View
15:40 – 16:40 CEST
An overview of AI, Software and Cybersecurity regulations in Asia
Location: B 09
Presenter: Zhencan Xu, M.Sc. – FSQ Experts
Presenter: Harshita Menon, MS – Merative
Presenter: Pei Yu (Amy) Chen – Compliance and risks
AI/Software
15:40 – 16:40 CEST
Blood, Sweat, and Tears – Biologics and Their Challenges
Location: A 05 + A 06
Moderator: Siegfried Schmitt, PhD – Parexel
Presenter: Ralf D. Hess, PhD – ENTOURAGE GmbH
Presenter: Yingying Liu, MSc – Pharmaceutcial
Pharmaceuticals
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
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
15:40 – 16:40 CEST
Regulatory Intelligence and Policy Strategy; Dynamic Regulatory Assessment as a Case Study
Location: A 03 + A 04
Presenter: Kasia A. Nowok, MSc – UCB
Presenter: Rüdiger Faust, PhD – UCB
Presenter: Nasir Hussain, BPharm, MBA, PhD – Gilead
Pharmaceuticals
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
16:40 – 17:15 CEST
Closing Remarks and Farewell Toast
Location: Level C Foyer
Supported by