Full Schedule

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Thursday, May 15, 2025
07:30 - 18:00 CEST
Registration
Location: Glass Entrance (-1)
07:30 - 18:30 CEST
Cloakroom
Location: Glass Entrance (-1)
08:30 - 09:30 CEST
Clean Industrial Deal
Location: The Arc (level 3)
Session Leader: Kate Stockman
Speaker: Veronika Jekerle, PhD – European Medicines Agency
Speaker: Kirsty Reid, PhD (she/her/hers) – EFPIA
Pharmaceuticals
08:30 - 09:30 CEST
Cybersecurity Across the Medical Device Lifecycle: Addressing Modern and Legacy Products
Location: Gold Hall (level 0)
Session Leader/Speaker: Julian Alpers, PhD (he/him/his) – seleon GmbH
Speaker: Kevin Veldman – Kiwa
Speaker: Pieter Smits – QbDGroup
Software/AI/Cybersecurity
08:30 - 09:30 CEST
EUDAMED Unlocked: Navigating the Current Landscape and Implementation Strategies
Location: Silver Hall (level 0)
Speaker: Patrick Pille, Dr – MDSS GmbH
Speaker: Richard Houlihan, MBA BSc – EirMed Ltd
Medical Devices
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
08:30 - 09:30 CEST
Reliance Pathways Such as WHO Collaborative Registration Procedure (CRP) to Accelerate the Assessment and Registration of Medicinal Products
Location: Studio 214 + 216 (level 2)
Speaker: Merce Caturla Goni, PhD (she/her/hers) – Alexion Astra Zeneca Rare Diseases
Speaker: Victoria Palmi Reig – European Medicines Agency (EMA)
Pharmaceuticals
08:30 - 09:30 CEST
The Power of Teamwork: Risk Management, Clinical Evaluation and PMS Aka “the Holy Trinity of the MDR” – but What About Claims?!
Location: Copper Hall (level 0)
Moderator: Robert A. van Boxtel – Medical Device Project B.V.
Speaker: Sarah Panten – avasis solutions GmbH / Medical Device Knowledge Unit e.V.
Speaker: Alexej Agibalow, n/a – Escentia GmbH
Speaker: Markus Poettker, n/a (he/him/his) – Smith&Nephew
Medical Devices
09:30 - 10:45 CEST
Presenters at Posters (Exhibition Hall: Level -2)
Location: Grand Hall 1/2 (Level -2)
09:30 - 10:45 CEST
Refreshment Break in the Exhibition Hall: Level -2)
Location: Grand Hall 1/2 (Level -2
09:40 - 10:10 CEST
Solutions Circle: "Growing Pains’: An Evaluation of Evolving Pediatric Study Regulation in the US and EU
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Sarah Arden, PhD – AstraZeneca
Solutions Circles
09:40 - 10:10 CEST
Solutions Circle: Decreasing Complexity, Defining Regulatory and Evaluation Strategy of LLM Based Functions
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Emilie Santos, PhD (she/her/hers) – Philips Healthcare
Solutions Circles
09:40 - 10:10 CEST
Solutions Circle: Impact of the Battery Regulation (EU) 2023/1542 on Medical Devices
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Christoph Kiesselbach (he/him/his) – Schrack & Partner
Solutions Circles
09:40 - 10:10 CEST
Solutions Circle: Key Takeaways from 4 Years of Expert Panel Views to Improve Your IVD Evaluation
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Beatriz Rodriguez Grande, PhD – NAMSA
Solutions Circles
09:45 - 10:10 CEST
MDSS Gmbh: The Importer Under MDR. Why the MDR Requirements Are a Blessing!
Location: Exhibit Hall - 1. Spark!
Speaker: Ludger Moeller (he/him/his) – MDSS GmbH
Sponsored Presentations
Supported by
09:45 - 10:10 CEST
Medsec LLC: Cybersecurity Risk Management: Your Next Submission’s Secret Weapon
Location: Exhibit Hall - 2.Discover!
Speaker: Michelle Jump, RAC, MS (she/her/hers) – MedSec LLC
Sponsored Presentations
Supported by
10:15 - 10:40 CEST
Osapiens / Byrd.health: Are You up to the 2025 EUDAMED Challenge?
Location: Exhibit Hall - 2.Discover!
Speaker: Henning Jaeger, M.A. – Osapiens for Medical Devices (BYRD Health)
Sponsored Presentations
Sponsored By
10:15 - 10:40 CEST
Weave Bio: Evaluating Time Savings in Regulatory Writing: A Scientific Comparison of Human and AI Approaches
Location: Exhibit Hall - 1. Spark!
Speaker: Lindsay Mateo, MBA (she/her/hers) – Weave Bio
Sponsored Presentations
Supported by
10:15 - 10:45 CEST
Solutions Circle: Challenges Related to Data in AI Medical Devices in the European Union
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Liliana Teles, PharmD, Msc (she/her/hers) – CRITICAL CATALYST
Solutions Circles
10:15 - 10:45 CEST
Solutions Circle: Cybersecurity in Premarket Submissions: US vs. EU Approach
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Taly Vider Cohen – MES Medical Electronic Systems
Solutions Circles
10:15 - 10:45 CEST
Solutions Circle: Insight in Motivation: The RA Life Stories That Matter in Healthcare
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Gert W. Bos, PhD FRAPS – QServe Group
Facilitator: Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS – TÜV SÜD Medical Health Services
Solutions Circles
10:45 - 11:45 CEST
Digital Transformation in Regulatory Tools and Dossier Submission
Location: Studio 214 + 216 (level 2)
Moderator & Presenter: Agnes Dangy-Caye, Dr (she/her/hers) – Agnès Dangy-Caye, Regulatory Science and Policy, Sanofi
Speaker: Ashley Jones-Mitchell, BS (she/her/hers) – Accumulus Synergy
Speaker: Hannes Kulovic – European Medicines Agency
Pharmaceuticals
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
10:45 - 11:45 CEST
Patient-centricity, Value, and Cost-effectiveness of Ai-enabled Medical Devices (AIeMDs)
Location: Copper Hall (level 0)
Session Leader/Speaker: Catarina Carrão – BioSciPons
Speaker: Zuzanna Kwade, MSc, PhD. (she/her/hers) – Dedalus Healthcare
Speaker: Anastasia Chalkidou, MD, MA, MSc, PhD – National Institute for Health and Care Excellence
Software/AI/Cybersecurity
10:45 - 11:45 CEST
Patient-focused Drug Development in EU: From EPAR to Smpc?
Location: The Arc (level 3)
Session Leader: Charlie Mortazavi, PharmD, MSc – AstraZeneca Rare Diseases, Alexion
Speaker: Amaia Clemente, Pharmacist – Sanofi
Speaker: Kaisa Immonen, MA – European Medicines Agency
Speaker: Nikos Dedes
Pharmaceuticals
10:45 - 11:45 CEST
Revolutionizing Product Safety and Performance: The Role of Computational Modelling, in Silico Trials, and Global Standards
Location: Gold Hall (level 0)
Speaker: Gavin Quigley, MBChB FRCS MBA – British Standards Institution
Speaker: Alejandro Federico Frangi, FREng FIEEE – University of Manchester
Speaker: Jeff Bischoff, PhD – Zimmer Biomet
Speaker: Michael Kipping, PhD – Element Materials Technology | University of Manchester
Medical Devices
10:45 - 11:45 CEST
UK Regulatory Landscape: UK MDR Amendments and Impact
Location: Studio 211 + 212 (level 2)
Moderator: Sue Spencer – Compliance Connextions Limited
Speaker: Monisha Phillips (she/her/hers) – TUV SUD
Speaker: Vishal Thakker, MEng (he/him/his) – BSI
Speaker: Robert Reid (he/him/his) – MHRA
Medical Devices
12:00 - 13:00 CEST
CMC Strategy / ICH Q9
Location: The Arc (level 3)
Speaker: Olga Braem, PhD – Kyowa Kirin
Speaker: Veronika Jekerle, PhD – European Medicines Agency
Pharmaceuticals
12:00 - 13:00 CEST
Current Developments and Regulatory Trends in Clinical Trial Design
Location: Studio 214 + 216 (level 2)
Session Leader/Speaker: Cecil J. Nick, BSc (Hons) – Parexel
Speaker: Darius-Jean Namdjou, PhD – Phortas GmbH
Pharmaceuticals
12:00 - 13:00 CEST
Mastering US FDA Cybersecurity Submissions: Requirements, Deficiencies, and Best Practices
Location: Copper Hall (level 0)
Session Leader/Speaker: Matthew Hazelett (he/him/his) – MedSec
Speaker: Rene' Hardee, MS (she/her/hers) – MedSec
Software/AI/Cybersecurity
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
12:00 - 13:00 CEST
Navigating the Intersection of MDR and HTA: Strategic Implications for Medical Device Manufacturers
Location: Silver Hall (level 0)
Session Leader/Speaker: thomas miramond – NAMSA
Medical Devices
12:00 - 13:00 CEST
PSUR: Requirements, Experiences and Lessons Learned to Date from Three Stakeholder Perspectives
Location: Gold Hall (level 0)
Moderator & Presenter: Jenifer Hannon, MTOPRA (she/her/hers) – BSI
Speaker: Sietske Eerens (she/her/hers) – Dutch Health and Youth Care Inspectorate (IGJ)
Speaker: Markus Poettker, n/a (he/him/his) – Smith&Nephew
Medical Devices
13:00 - 14:30 CEST
Networking Lunch in Exhibition Hall
Location: Grand Hall 1/2 (Level -2)
13:10 - 13:35 CEST
Medboard: Streamlining Regulatory Intelligence and Literature Reviews with Automation and AI: Case Studies and Proven Value
Location: Exhibit Hall - 1. Spark!
Speaker: Ivan Perez Chamorro – MedBoard
Sponsored Presentations
Supported by
13:10 - 13:35 CEST
Pearl Pathways: The Global Regulatory Landscape for Companion Diagnostics
Location: Exhibit Hall - 2.Discover!
Speaker: Kimberley Buytaert-Hoefen, Ph.D – Pearl Pathways, part of Versiti Clinical Trial Services
Sponsored Presentations
Supported by
13:15 - 13:45 CEST
Solutions Circle: Intended Use: The Foundations of the Medical Device House
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Amie Smirthwaite, BEng, PhD, FRAPS – Osteogen Ltd
Solutions Circles
13:15 - 13:45 CEST
Solutions Circle: Points to Consider in Deciding on Placebo/active Comparators in Clinical Trials
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Karl-Heinz Huemer, PhD MD (he/him/his) – khhconsulting
Solutions Circles
13:15 - 13:45 CEST
Solutions Circle: Structured Dialogue - IVDR - Live Example
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Tom Patten, n/a – GMED Certification Division
Solutions Circles
13:15 - 13:45 CEST
Solutions Circle: Surviving the EHDS: A Lifeline
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Cecile E. van der Heijden (she/her/hers) – Axon Lawyers
Solutions Circles
13:40 - 14:05 CEST
Lexisnexis Reed Tech: EUDAMED UDI: What You Need to Know to Be Compliant
Location: Exhibit Hall - 2.Discover!
Speaker: Gary Saner – LexisNexis Reed Tech
Sponsored Presentations
Supported by
13:40 - 14:05 CEST
Qserve Group: Navigating the Political Shifts in Global Regulatory Affairs
Location: Exhibit Hall - 1. Spark!
Speaker: Gert W. Bos, PhD FRAPS – QServe Group
Speaker: Robert Paassen, MSc (he/him/his) – Qserve Group
Sponsored Presentations
Supported by
13:50 - 14:20 CEST
Solutions Circle: FDA unannounced audits
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Leo Hovestadt – Elekta
Facilitator: Martin de Bruin
Solutions Circles
13:50 - 14:20 CEST
Solutions Circle: key Considerations for Cdx in Combined Trials Under IVDR
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Maham Ansari, MS, RAC – Precision for Medicine
Solutions Circles
13:50 - 14:20 CEST
Solutions Circle: Mastering PSURs: Streamline Your Process for Faster Approvals
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Adam Kijowski, PhD – Geistlich Pharma AG
Solutions Circles
13:50 - 14:20 CEST
Solutions Circle: The Journey to Becoming RCC Certified!
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Jennifer Neff, PhD – Entourage GmbH
Solutions Circles
14:05 - 14:30 CEST
Greenlight Guru: 2025 State of the Medical Device Industry Report
Location: Exhibit Hall - 1. Spark!
Presenter: Taylor Holcomb, MS – Greenlight Guru
Sponsored Presentations
Supported by
14:05 - 14:30 CEST
Ketryx Corporation: Ai-driven Document Orchestration and Generation: Managing Systems of Systems, Modular Software Services, and Compliance at Scale
Location: Exhibit Hall - 2.Discover!
Speaker: Jenn Dixon, P.Eng (she/her/hers) – Ketryx
Speaker: Natalie Batty, MPH – Aignostics
Sponsored Presentations
Supported by
14:30 - 15:30 CEST
Benefits of Standardized Data Models for Digitalization in the Medtech Industry
Location: Copper Hall (level 0)
Session Leader: Sarah Panten – avasis solutions GmbH / Medical Device Knowledge Unit e.V.
Speaker: Daniel Prell, MBA, Dr. (he/him/his) – Siemens Healthineers AG
Speaker: Frédéric Said, n/a – Siemens Healthineers AG
Medical Devices
14:30 - 15:30 CEST
Combined Studies: Interface Between the Regulations on Clinical Trials of Medicinal Products, Medical Devices and in vitro Diagnostics (Current Situation and Future Regulatory Framework)
Location: Gold Hall (level 0)
Moderator: Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting
Speaker: Piritta M. Maunu (she/her/hers) – PharmaLex Finland
Speaker: Natalie Batty, MPH – Aignostics
Speaker: Ditte Zerlang Andersen, PhD (she/her/hers) – Danish Medicines Agency (DKMA)
Panelist: Christelle Bouygues, PharmD – EMA
Pharmaceuticals
14:30 - 15:30 CEST
From Confusion to Clarity: Decoding US and European Regulatory Meetings During Development, for Optimal Results
Location: The Arc (level 3)
Session Leader: Charlie Mortazavi, PharmD, MSc – AstraZeneca Rare Diseases, Alexion
Speaker: Hagit Marchaim, PhD, MBA (she/her/hers) – HMC-regulation
Speaker: Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency
Speaker: Christophe Lahorte – FAGG - Federal agency for medicines and health products (Belgium)
Pharmaceuticals
14:30 - 15:30 CEST
From Wellness to Clinical Care: Regulating at the Intersection of Medical and Non-Medical Devices in Hybrid Digital Health/AI Suites
Location: Studio 214 + 216 (level 2)
Session Leader: Stephen Gilbert, PhD (he/him/his) – Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Speaker: Rebecca Mathias, MSc (she/her/hers) – Else Kröner Fresenius Center for Digital Health,TUD Dresden University of Technology
Speaker: Vincent Vercamer, PhD – DNS - French Ministry of Health
Software/AI/Cybersecurity
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
14:30 - 15:30 CEST
Using IMDRF Codes to Analyse Complaints and Connections with Risk Management
Location: Silver Hall (level 0)
Moderator & Presenter: Keith Morel, PhD (he/him/his) – Qserve
Speaker: Gregory Duby
Medical Devices
15:30 - 16:45 CEST
Presenters at Posters (Exhibition Hall: Level -2)
Location: Grand Hall 1/2 (Level -2)
15:30 - 16:45 CEST
Refreshment Break in the Exhibition Hall: Level -2)
Location: Grand Hall 1/2 (Level -2
15:45 - 16:10 CEST
Kiwa Medical: MDR and Clinical Investigation: What’s New?
Location: Exhibit Hall - 1. Spark!
Speaker: Chirine El Baba, PhD – Kiwa
Sponsored Presentations
Supported by
15:45 - 16:10 CEST
TÜV SÜD: MDR Structured Dialogue: Clinical Edition
Location: Exhibit Hall - 2.Discover!
Speaker: Martin Witte (he/him/his) – TÜV SÜD Medical & Health Services
Sponsored Presentations
Sponsored By:
16:15 - 16:40 CEST
1MED SA: Do I Really Need a Trial? - Smart Solutions to Collect Clinical Data
Location: Exhibit Hall - 2.Discover!
Speaker: Alessandro Malaspina, MS (he/him/his) – 1MED
Sponsored Presentations
Supported by
16:15 - 16:40 CEST
MAIN5: EMA PMS Data Alignment: Automating Medicinal Product Data Compliance with Improved Operational Efficiency
Location: Exhibit Hall - 1. Spark!
Speaker: Michiel Stam – MAIN5
Sponsored Presentations
Supported by
16:45 - 17:45 CEST
Bringing Innovative Medical Devices to the EU Market
Location: Silver Hall (level 0)
Moderator: Giovanni Di Rienzo – Edwards Lifesciences
Speaker: Ana Matos Machado, MD – Tuv Sud
Speaker: Javier Castillo, MSc EMBA – INBRAIN Neuroelectronics
Speaker: Alberto Ganan, PhD – European Medicines Agency
Medical Devices
16:45 - 17:45 CEST
China: Key Regulatory & Clinical Updates and Their Implementation
Location: Studio 211 + 212 (level 2)
Speaker: Grace F. Palma, MBA (she/her/hers) – China Med Device, LLC
Speaker: Hamish King, RAC, LLB – Cisema
Speaker: Xiaowei Sun, M.D & Ph. D (she/her/hers) – Royal Philips
Medical Devices
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
16:45 - 17:45 CEST
EMA and FDA Programs to Accelerate Innovation in Treating Unmet Medical Needs
Location: Studio 214 + 216 (level 2)
Moderator: Stefanie Fasshauer, MBA – Cisema
Speaker: Hagit Marchaim, PhD, MBA (she/her/hers) – HMC-regulation
Speaker: Kristina Larsson, MSc – European Medicines Agency
Speaker: Shannon Thor – U.S. Food and Drug Administration U.S. Mission to the European Union
Pharmaceuticals
16:45 - 17:45 CEST
Evolving with Technology: Navigating Current Regulatory Challenges and Future Directions in IoMT Cybersecurity
Location: Gold Hall (level 0)
Moderator & Presenter: Oscar Freyer (he/him/his) – Else Kröner Fresenius Center for Digital Health,TUD Dresden University of Technology
Speaker: Julian Alpers, PhD (he/him/his) – seleon GmbH
Speaker: Pascal Werner, M.Sc. – Ostrich Consulting LLC
Speaker: Alexander Stock, PhD (he/him/his) – TÜV SÜD
Software/AI/Cybersecurity
16:45 - 17:45 CEST
The Value of Integrating Real-world and Trial Data to Increase Patient Benefit
Location: The Arc (level 3)
Session Leader: Charlie Mortazavi, PharmD, MSc – AstraZeneca Rare Diseases, Alexion
Speaker: Cecil J. Nick, BSc (Hons) – Parexel
Speaker: Muriel Pasté, PhD (she/her/hers) – UCB
Panelist: Andrej Segec, MPharm MSc – European Medicines Agency
Pharmaceuticals