Full Schedule

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Tuesday, May 13, 2025
07:30 - 19:00 CEST
Registration
Location: Glass Entrance (-1)
07:30 - 20:00 CEST
Cloakroom
Location: Glass Entrance (-1)
08:30 - 16:00 CEST
Preconference Workshop: Clinical Evaluation - Optimizing Clinical Data and State-of-the-art Searches for MDR Compliance
Location: Studio 211 (level 2)
Speaker: Christiane Reinwald, PhD (Dr. rer. nat.) – be-on-Quality GmbH
Speaker: Mette Stoedter, PhD (Dr rer medic) (she/her/hers) – be-on-Quality GmbH
Speaker: David John Mandley, PhD (he/him/his) – NAMSA
Medical Devices
08:30 - 16:00 CEST
Preconference Workshop: EU Pharmaceutical Regulatory Reform
Location: Studio 202 (level 2)
Workshop Leader: Rebecca Lumsden, PhD (she/her/hers) – Sanofi
Speaker: Yves Jacob (he/him/his) – Sanofi
Speaker: Alberto Ganan, PhD – European Medicines Agency
Speaker: Lilia Luchianov – European Commission
Speaker: Nikos Dedes
Pharmaceuticals
08:30 - 16:00 CEST
Preconference Workshop: From Concept to Compliance: Overcoming the Regulatory Challenges of Clinical Performance Studies
Location: Studio 204 (level 2)
Speaker: Natalie Batty, MPH – Aignostics
Speaker: Marina Belonogova, PhD (she/her/hers) – Johnson and Johnson
Speaker: Kristiane Schmidt, PhD (she/her/hers) – Qserve Consultancy BV
Speaker: Carlos Galamba – MDx CRO
IVDs
08:30 - 16:00 CEST
Preconference Workshop: AI - Your Best Buddy on the Path to Regulatory Compliance
Location: Studio 201 AB (level 2)
Speaker: Florian Tolkmitt, n/a – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Speaker: Stephen Gilbert, PhD (he/him/his) – Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Speaker: Sarai Pahla, Bachelors Degree in Medicine and Surgery, Masters Degree in Regulatory Affairs – CriterionEdge, self-employed
Software/AI/Cybersecurity
08:30 - 16:00 CEST
Preconference Workshop: IVDR Technical Documentation
Location: Studio 206 (level 2)
Workshop Leader: Francesca Bevilacqua, PhD (she/her/hers) – TÜV SÜD Italy
Speaker: Catherine Holzmann, PhD – GMED Certification Division
Speaker: Alex Laan, Dipl.-Ing. (he/him/his) – BSI
Speaker: Marco Caproni (he/him/his) – TUV SUD
Speaker: Guillaume Berger – GMED
IVDs
08:30 - 16:00 CEST
Preconference Workshop: PMS Process- dos and Don'ts
Location: Studio 212 (level 2)
Speaker: Vaso Basinou, PhD (she/her/hers) – Freelancer
Speaker: Ivan Stoyanov, Dr. – SGS Notified Body, 1639
Speaker: Andrea Biasiucci, PhD – confinis
Speaker: Claudio Alberti, PhD (he/him/his) – confinis
Medical Devices
14:00 - 15:00 CEST
RAPS Career Development Session for Students
Location: Studio 312
Moderator: Kim Young, MSc (she/her/hers) – RAPS
Panelist: Maham Ansari, MS, RAC – Precision for Medicine
Panelist: Kate Stockman
Panelist: Corinne Delorme, RAC – nexialist
Panelist: Michal Wosiak, MPharm (he/him/his) – Pharmaceutical Company
16:30 - 18:30 CEST
Euro Convergence 2025 Welcome and Opening Plenary: The Future of Regulation and European Competitiveness
Location: Gold Hall (level 0)
Keynote Panelist: Peter Bischoff-Everding, PhD (he/him/his) – European Commission, Directorate-General Health and Food safety
Moderator: Koen Cobbaert (he/him/his) – Philips
Panelist: Stephen Gilbert, PhD (he/him/his) – Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Panelist: Jana Russo, MA – MedTech Europe
Panelist: Steffen Thirstrup, MD, PhD (he/him/his) – European Medicines Agency (EMA)
Panelist: Erik R. Vollebregt – Axon Lawyers
18:30 - 19:30 CEST
Opening Reception in Exhibition Hall
Location: Grand Hall 1/2 (Level -2)
Supported by
Wednesday, May 14, 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
America First – Europe Second? Defining Global Market Access Strategies for Start-ups and New Devices
Location: Studio 211 + 212 (level 2)
Moderator: Kristiane Schmidt, PhD (she/her/hers) – Qserve Consultancy BV
Speaker: Sue Spencer – Compliance Connextions Limited
Speaker: Pierre-Emmanuel Thiriet, Dr. (he/him/his) – Rea Diagnostics
Speaker: Diana Rosentul, PhD (she/her/hers) – Aiosyn
IVDs
08:30 - 09:30 CEST
Current and Future MedTech AI Regulatory Landscape in the U.S.
Location: Studio 214 + 216 (level 2)
Presenter: Eric Henry, BS – King & Spalding LLP
Software/AI/Cybersecurity
08:30 - 09:30 CEST
EU Pharmaceutical Regulatory Reforms – Time to Consider Implementation Challenges and Opportunities?
Location: Copper Hall (level 0)
Moderator & Presenter: Rebecca Lumsden, PhD (she/her/hers) – Sanofi
Speaker: Yves Jacob (he/him/his) – Sanofi
Speaker: Steffen Thirstrup, MD, PhD (he/him/his) – European Medicines Agency (EMA)
Speaker: Lilia Luchianov – European Commission
Speaker: Nikos Dedes
Speaker: Aimad Torqui – MSD
Pharmaceuticals
08:30 - 09:30 CEST
Innovating Regulation: The Use of AI by Notified Bodies for Conformity Assessment
Location: Silver Hall (level 0)
Moderator: Susana de Azevedo Wäsch – Ypsomed
Speaker: Ingela Mauritzon, MSc (she/her/hers) – Halmstad University
Speaker: Daniela Seneca, MEng (she/her/hers) – BSI
Speaker: Sebastian Fischer – TÜV SÜD Product Service GmbH
Medical Devices
08:30 - 09:30 CEST
MDR Kick-off Panel
Location: Gold Hall (level 0)
Speaker: Gert W. Bos, PhD FRAPS – QServe Group
Speaker: Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS – TÜV SÜD Medical Health Services
Speaker: Maria-Chiara Orlandi – European Commission
Speaker: Martin Witte (he/him/his) – TÜV SÜD Medical & Health Services
Speaker: Stephan Affolter – Ypsomed AG
Medical Devices
08:30 - 09:30 CEST
Regulatory Considerations for Gene Therapy in Pediatric Patients
Location: The Arc (level 3)
Moderator: Stefanie Fasshauer, MBA – Cisema
Speaker: Johnathan Akers, Masters of Clinical Research – Independent Regulatory Affairs Professional
Speaker: Giovanni Lesa, PhD – European Medicines Agency
Pharmaceuticals
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 Reg Desk: Global Market Expansion: Navigating Multi-market Regulatory Complexities
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Priya Paul, BS, MS, MS (she/her/hers) – RegDesk, Inc.
Solutions Circles
Supported by
09:40 - 10:10 CEST
Solutions Circle: FDA unannounced audits
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Gert W. Bos, PhD FRAPS – QServe Group
Facilitator: Leo Hovestadt – Elekta
Solutions Circles
09:40 - 10:10 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
09:40 - 10:10 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
09:40 - 10:10 CEST
Solutions Circle: The Journey to Becoming RCC Certified!
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Stuart Angell
Solutions Circles
09:45 - 10:10 CEST
Celegence: AI in Technical and Clinical Writing: Cutting Through the Hype with Real-world Examples
Location: Exhibit Hall - 2.Discover!
Speaker: Joseph-Richardson Larbi, MSc – Celegence
Sponsored Presentations
Supported by
09:45 - 10:10 CEST
Johner Institut Gmbh: Regulatory Intelligence E2E – Is It Worth the Invest?
Location: Exhibit Hall - 1. Spark!
Speaker: Andrea Seeck – Johner Institut GmbH
Speaker: Leon Holub – Johner Institut GmbH
Sponsored Presentations
Supported by
09:45 - 10:45 CEST
Chapters and Local Networking Groups Meet and Greet
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
10:15 - 10:40 CEST
NAMSA: Understanding FDA Preclinical Animal Study Requirements for Medical Devices
Location: Exhibit Hall - 1. Spark!
Speaker: Gaëlle Clermont, Pharm.D., PhD (she/her/hers) – NAMSA
Sponsored Presentations
Supported by
10:15 - 10:40 CEST
Purdie Pascoe: Mastering PMCF Data Collection: How to Overcome Challenges with PMCF Surveys
Location: Exhibit Hall - 2.Discover!
Speaker: Marcus Torr, MSci – Purdie Pascoe
Speaker: Gavin Quigley, MBChB FRCS MBA – British Standards Institution
Sponsored Presentations
Supported by
10:15 - 10:45 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
10:15 - 10:45 CEST
Solutions Circle Ketryx Corporation: Put Your Model to the Test—Exploring Off-the-shelf AI for Medical Devices
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Jenn Dixon, P.Eng (she/her/hers) – Ketryx
Solutions Circles
10:15 - 10:45 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
10:15 - 10:45 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
10:15 - 10:45 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
10:45 - 11:45 CEST
“Appropriateness” of Clinical Data – Clinical Evaluations Based on Non-clinical Data Only
Location: Copper Hall (level 0)
Speaker: Elisabeth Oltmanns, M.Sc. (she/her/hers) – Escentia GmbH
Speaker: Michael D'Agosto, Prof Dr (he/him/his) – Hochschule Furtwangen University
Speaker: Breda kearney, BSc, MSc – BSI
Medical Devices
10:45 - 11:45 CEST
Addressing the Complexities of Using in Vitro Diagnostics (IVDs) in Global Clinical Trials
Location: Studio 214 + 216 (level 2)
Moderator & Presenter: Kirsten Van Garsse, RCC-IVDR (she/her/hers) – Qarad (Part of the QbD Group)
Speaker: Sara Van Wouwe, RCC-IVDR (she/her/hers) – Qarad (part of the QbD Group)
Speaker: Erica Conway, BSc, PhD (she/her/hers) – GSK
IVDs
10:45 - 11:45 CEST
Biosimilar Development
Location: Silver Hall (level 0)
Session Leader: Charlie Mortazavi, PharmD, MSc – AstraZeneca Rare Diseases, Alexion
Speaker: Cecil J. Nick, BSc (Hons) – Parexel
Speaker: Steffen Thirstrup, MD, PhD (he/him/his) – European Medicines Agency (EMA)
Speaker: Marija Pesic, Phd (she/her/hers) – Formycon AG, Martinsried/Planegg, Germany
Pharmaceuticals
10:45 - 11:45 CEST
EU Variation Regulatory Reform – Creating Innovation in the Life-cycle Management
Location: The Arc (level 3)
Speaker: Agnes Dangy-Caye, Dr (she/her/hers) – Agnès Dangy-Caye, Regulatory Science and Policy, Sanofi
Speaker: Estelle A. Massoubre (she/her/hers) – Kenvue
Speaker: Alberto Ganan, PhD – European Medicines Agency
Pharmaceuticals
10:45 - 11:45 CEST
Global Perspectives on Usability and Human Factors Studies in Regulatory Submissions: Navigating the US, EU, and China Landscape
Location: Studio 211 + 212 (level 2)
Session Leader/Speaker: Beat U. Steffen, MSc, RAC, FRAPS (he/him/his) – confinis ag
Speaker: Yan Sheng, PhD – China Med Device, LLC
Speaker: Jenny Wu
Speaker: Monica Tavanti, PhD – CSL Behring
Medical Devices
10:45 - 11:45 CEST
The EU AI Act
Location: Gold Hall (level 0)
Speaker: Udo Heintz, PhD (he/him/his) – Ada Health GmbH
Speaker: Sarah Mathew – BSI
Speaker: Marco Caproni (he/him/his) – TUV SUD
Speaker: Nada Alkhayat – European Commission
Moderator: Koen Cobbaert (he/him/his) – Philips
Software/AI/Cybersecurity
12:00 - 13:00 CEST
AI Testbeds
Location: Gold Hall (level 0)
Moderator: Koen Cobbaert (he/him/his) – Philips
Speaker: Alexander von Janowski, MSc – TÜV AI.Lab
Speaker: Natascha J. Cuper, PhD – Kiwa Dare
Speaker: Sabyne van Mourik, MBA RSE (she/her/hers) – Kiwa Nederland BV
Speaker: Jérôme-Alexis Chevalier, PhD – National Laboratory of Metrology and Testing (LNE)
Software/AI/Cybersecurity
12:00 - 13:00 CEST
Changes in U.S. Politics: Implications for Submissions and Agency Collaboration
Location: Silver Hall (level 0)
Speaker: Amra Racic – Veeva MedTech
Speaker: Gertjan Geelen, MSc – dsm-firmenich Biomedical
Speaker: Nataliya Deych (she/her/hers) – Edwards Lifesciences Sarl
Medical Devices
12:00 - 13:00 CEST
HTA Regulation, Joint Clinical Assessments (JCA) & Joint Scientific Consultations (JSC): Adapting to the New EU Framework
Location: The Arc (level 3)
Session Leader/Speaker: Antje Behring
Speaker: Michael Berntgen, PhD MDRA – European Medicines Agency
Speaker: Anne Willemsen
Pharmaceuticals
12:00 - 13:00 CEST
Mastering IVD Software Classification and Overcoming PMS Regulatory Compliance Challenges at the Interface of the IVDR and the AI Act
Location: Copper Hall (level 0)
Moderator & Presenter: Anca-Sarmiza Gültekin-Tigan, Dr / MSc (she/her/hers) – QUAREGIA GmbH
Speaker: Mohamed-Salah Garouachi, PharmD – Constency Healthcare
Speaker: Alexander Stock, PhD (he/him/his) – TÜV SÜD
IVDs
12:00 - 13:00 CEST
Maximizing the Value of Clinical Data for Global Submissions (EU/China)
Location: Studio 211 + 212 (level 2)
Session Leader: Florian Tolkmitt, n/a – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Presenter: Maria Camara Torres, PhD – Qserve Group
Speaker: Yu Jin, MD, PhD (she/her/hers) – Notified Body 1639, SGS Belgium
Speaker: Yan Sheng, PhD – China Med Device, LLC
Speaker: Johanna Sorsa, Dr (she/her/hers) – Siemens Healthineers AG
Medical Devices
12:00 - 13:00 CEST
New International: Experiences with the Latest UK Submission Routes
Location: Studio 214 + 216 (level 2)
Session Leader: Kate Stockman
Speaker: Peter Fry – QbD Group
Speaker: Tasneem Fatima Keshavji – MHRA
Speaker: James Crooks – Product Life Group
Pharmaceuticals
13:00 - 14:30 CEST
Networking Lunch in Exhibition Hall
Location: Grand Hall 1/2 (Level -2)
Supported by
13:10 - 13:35 CEST
Flinn AI: The AI Validation Confidence Index - Discover How Much You Can Trust Your AI
Location: Exhibit Hall - 2.Discover!
Speaker: Tibor Zechmeister, BSc MSc EMBA – Flinn.ai
Sponsored Presentations
Supported by
13:10 - 13:35 CEST
Medenvoy Global: Ensuring Compliance Across the Distribution Chain: A Deep Dive into Economic Operators’ Roles
Location: Exhibit Hall - 1. Spark!
Speaker: Daniëlle Sleegers – MedEnvoy Global
Sponsored Presentations
Supported by
13:15 - 13:45 CEST
Solutions Circle Greenlight Guru: Using Clinical Data for More Than Regulatory Approval
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Páll Johannesson – Greenlight Guru
Solutions Circles
Supported by
13:15 - 13:45 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
13:15 - 13:45 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
13:15 - 13:45 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
13:15 - 13:45 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
13:30 - 14:15 CEST
RAPS Speed Mentoring
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
13:40 - 14:05 CEST
Eclevar Medtech: Smart PMCF for Medical Devices: AI-powered EDC for Cost Savings, MDR Compliance
Location: Exhibit Hall - 2.Discover!
Speaker: Chems Hachani – Eclevar Medtech
Sponsored Presentations
Supported by
13:40 - 14:05 CEST
Qbd Group: Can IVDR Be Your Global Regulatory Compass for Market Entry?
Location: Exhibit Hall - 1. Spark!
Speaker: Pieter C. Bogaert, PhD (he/him/his) – Qarad (part of QbD Group)
Sponsored Presentations
Supported by
13:50 - 14:20 CEST
Solutions Circle LexisNexis Reed Tech: Tips and Tricks for Managing Global UDI Submissions
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Robin Schilling – LexisNexis Reed Tech
Solutions Circles
Supported by
13:50 - 14:20 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
13:50 - 14:20 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
13:50 - 14:20 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
14:05 - 14:30 CEST
RIMSYS: Getting Your Ducks in a Row for a Successful EUDAMED (and Global) UDI Program
Location: Exhibit Hall - 1. Spark!
Speaker: Adam Price, MBA – Rimsys
Sponsored Presentations
Supported by
14:05 - 14:30 CEST
RQM+: Quo Vadis, FDA - And Where Should We Go To...?
Location: Exhibit Hall - 2.Discover!
Speaker: Alexia Haralambous, MS, RAC – RQM+
Sponsored Presentations
Supported by
14:30 - 15:30 CEST
EU Green Deal
Location: Studio 211 + 212 (level 2)
Speaker: Erik R. Vollebregt – Axon Lawyers
Speaker: Sonja Hirte, PhD (she/her/hers) – PRO-LIANCE GLOBAL SOLUTIONS
Speaker: Anja Siegemund
Medical Devices
14:30 - 15:30 CEST
Accelerating Clinical Trials in EU
Location: The Arc (level 3)
Session Leader/Speaker: Rüdiger Faust, PhD – UCB
Speaker: Laura Pioppo, Ms – EMA
Pharmaceuticals
14:30 - 15:30 CEST
AI Sandboxes and Assurances
Location: Copper Hall (level 0)
Moderator: Celia Cruz, PhD (she/her/hers) – Complear
Speaker: Hannah Bowden, PhD (she/her/hers) – Medicines and Healthcare products Regulatory Agency
Speaker: Natasha Motsi, PhD (she/her/hers) – Medicines and Healthcare products Regulatory Agency
Speaker: Antonino Rotolo
Speaker: Liron Bar Yaakov
Panelist: Alberto Ganan, PhD – European Medicines Agency
Software/AI/Cybersecurity
14:30 - 15:30 CEST
Career Development: Live Linkedin Review Session
Location: Exhibit Hall - 1. Spark!
Speaker: Elena Kyria (she/her/hers) – Elemed
14:30 - 15:30 CEST
Clinical Data Challenges for Novel and Legacy Medical Devices - Panel Discussion with Clinical Experts from Multiple Notified Bodies
Location: Gold Hall (level 0)
Moderator & Presenter: Matthias Fink – AKRA TEAM Inc.
Speaker: Richard G. Holborow, n.a. (he/him/his) – BSI
Speaker: Ulrich Nitsche, MD, PhD (he/him/his) – TÜV SÜD Product Service GmbH
Speaker: Christoph Ziskoven (he/him/his) – TÜV Rheinland LGA Products GmbH
Speaker: Paul Piscoi – European Commission - Directorate-General for Health and Food Safety
Medical Devices
14:30 - 15:30 CEST
Medicines Shortages
Location: Studio 214 + 216 (level 2)
Moderator: Michael Craig – Parexel
Speaker: Monica Dias, PhD (she/her/hers) – EMA
Speaker: Caroline De Bodt, PhD (she/her/hers) – UCB
Speaker: Anuja Shukla, MBA (she/her/hers) – UCB Pharma
Speaker: Pieter Jan Desiere – European Medicines Agency (EMA)
Speaker: Solene Jouan
Pharmaceuticals
14:30 - 15:30 CEST
The Road Ahead: Impact of EU 2024/1860 for MDR and IVDR – Insights from Notified Bodies and Industry
Location: Silver Hall (level 0)
Speaker: Margot Borgel, PhD – RQM+
Speaker: Edward Ball, CEng MIPEM (he/him/his) – RQM+
Speaker: Maddalena Pinsi, MSc – BSI
Speaker: Sara Fabi, MSc – BSI
IVDs
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
Essenvia RIM Platform: Navigating the Perfect Storm: FDA Capacity Cuts, Tariffs & the New RA Playbook
Location: Exhibit Hall - 1. Spark!
Speaker: Soumya Mahapatra (he/him/his) – Essenvia
Sponsored Presentations
Supported by
15:45 - 16:10 CEST
Pure Global: AI in Action - Transforming Regulatory Workflows for Smarter Technical Documentation and Global Submissions
Location: Exhibit Hall - 2.Discover!
Speaker: Oliver Eikenberg – Pure Global
Sponsored Presentations
Supported by
16:15 - 16:40 CEST
REG DESK: The Future of Regulatory Affairs: how Technology Is Shaping Regulatory Compliance
Location: Exhibit Hall - 1. Spark!
Speaker: Priya Paul, BS, MS, MS (she/her/hers) – RegDesk, Inc.
Sponsored Presentations
Supported by
16:15 - 16:40 CEST
Veeva Systems Inc: Exploring the Ai-powered Future of Promotional Material Review
Location: Exhibit Hall - 2.Discover!
Moderator: Pearl Vyas – Veeva Systems
Speaker: Michael Konings – Philips
Speaker: Erik R. Vollebregt – Axon Lawyers
Sponsored Presentations
Supported by
16:45 - 18:00 CEST
Conversations That Matter: Interactions with Health Authorities
Location: Gold Hall (level 0)
Moderator: Sabine Haubenreisser, MSc, PhD, FRAPS – European Medicines Agency
Moderator: Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS – TÜV SÜD Medical Health Services
Panelist: Steffen Thirstrup, MD, PhD (he/him/his) – European Medicines Agency (EMA)
Panelist: Christelle Bouygues, PharmD – EMA
Panelist: Alberto Ganan, PhD – European Medicines Agency
Panelist: Suzanne Halliday, DPhil, FRAPS – BSI
Panelist: Coen Brummer – Ministry of Health, Welfare and Sports
Panelist: Paul Piscoi – European Commission - Directorate-General for Health and Food Safety
18:00 - 21:00 CEST
Networking Dinner (Ticket Required): Plein Publiek
Supported by
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
Friday, May 16, 2025
07:30 - 13:30 CEST
Registration
Location: Glass Entrance (-1)
07:30 - 14:00 CEST
Cloakroom
Location: Glass Entrance (-1)
08:30 - 10:00 CEST
Plenary Session - Disruptive Innovation: Redefining Regulatory Roles
Location: Gold Hall (level 0)
Moderator: Gert W. Bos, PhD FRAPS – QServe Group
Moderator: Jennifer Neff, PhD – Entourage GmbH
Keynote Panelist: Rebecca Lumsden, PhD (she/her/hers) – Sanofi
Panelist: Stefanie Fasshauer, MBA – Cisema
Panelist: Udo Heintz, PhD (he/him/his) – Ada Health GmbH
Panelist: Muriel Pasté, PhD (she/her/hers) – UCB
Panelist: Michal Wosiak, MPharm (he/him/his) – Pharmaceutical Company
10:00 - 10:30 CEST
Refreshment Break
Location: Magritte + Silver Foyer (level 0)
10:30 - 11:30 CEST
All in One for Biocompatibility: ISO 10993 Updates, Toxicological Risk Assessment and Post-market Data
Location: Gold Hall (level 0)
Session Leader: Florian Tolkmitt, n/a – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Speaker: Marina Daineko, MSc (she/her/hers) – Intrinsic Medical Group
Speaker: alessia frabetti, PhD (she/her/hers) – Kiwa Cermet Italia SPA
Speaker: Jeremy Tinkler, ERT – ICON plc
Medical Devices
10:30 - 11:30 CEST
China Drug Regulatory Pathways: 2025 Key Updates and Deep-dive
Location: Studio 211 + 212 (level 2)
Session Leader/Speaker: Hamish King, RAC, LLB – Cisema
Speaker: Jacky Li, MSc – Cisema (Hong Kong) Limited
Pharmaceuticals
10:30 - 11:30 CEST
Mastering Post-market Surveillance Under IVDR: From PMPF to PSUR
Location: Silver Hall (level 0)
Session Leader: Anja Wiersma, PhD (she/her/hers) – mi-CE consultancy
Speaker: Liz Gommans, PhD (she/her/hers) – DEKRA B.V.
Speaker: Goran Abdurrahman, PhD (he/him/his) – TÜV Rheinland
Speaker: Leo WJ Klomp – Health and Youth Care Inspectorate (IGJ), Ministry of Health
IVDs
10:30 - 11:30 CEST
On Trend: The Important Considerations for Trend Reporting in Medical Device Safety
Location: Studio 214 + 216 (level 2)
Speaker: Edward Ball, CEng MIPEM (he/him/his) – RQM+
Speaker: Markus Poettker, n/a (he/him/his) – Smith&Nephew
Speaker: Ashley Stratton-Powell
Speaker: Sofia Prata, PhD – DQS
Medical Devices
10:30 - 11:30 CEST
Shaping the Future of mRNA Vaccines: A Regulatory Perspective
Location: The Arc (level 3)
Moderator: Stefanie Fasshauer, MBA – Cisema
Presenter: Mohamad Toutounji (he/him/his) – Molgenium
Speaker: Thomas Larsson, MSc, BSc – European Medicines Agency
Pharmaceuticals
10:30 - 11:30 CEST
Supply Chain Cybersecurity Risk Management
Location: Copper Hall (level 0)
Session Leader/Speaker: Stefan Braun, MSc (he/him/his) – FSQ Experts a brand of Wertefest GmbH
Speaker: Sebastian Fischmeister, MASc, PhD, PEng (he/him/his) – University of Waterloo
Speaker: Ben Kokx – Philips
Software/AI/Cybersecurity
11:45 - 12:45 CEST
Adaptive and Evolving Ai-enabled Medical Devices
Location: Silver Hall (level 0)
Moderator & Presenter: Koen Cobbaert (he/him/his) – Philips
Speaker: Stephen Gilbert, PhD (he/him/his) – Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Speaker: Eric Henry, BS – King & Spalding LLP
Software/AI/Cybersecurity
11:45 - 12:45 CEST
Device - Drug Borderlines – Challenges in Europe and the USA
Location: The Arc (level 3)
Session Leader/Speaker: Jane L. Arnold-Round, B.Eng Msc. – NAMSA
Speaker: Ortzi OLASOLO – Beyond Conception GmbH
Speaker: Alberto Ganan, PhD – European Medicines Agency
Panelist: Sebastian Fischer – TÜV SÜD Product Service GmbH
Pharmaceuticals
11:45 - 12:45 CEST
Involving European Reference Laboratories in the Conformity Assessment of Class D Ivd's: Operational Update After 6 Months
Location: Copper Hall (level 0)
Moderator: Kirsten Van Garsse, RCC-IVDR (she/her/hers) – Qarad (Part of the QbD Group)
Speaker: Alex Laan, Dipl.-Ing. (he/him/his) – BSI
Speaker: Jennifer Rosendahl, PhD. (she/her/hers) – RISE
Speaker: Angela Filomena, Dr (she/her/hers) – Paul-Ehrlich-Institut
Speaker: Katja Mierish – Tuv Rheinland
Panelist: Aisha Sauer – European Commission
IVDs
11:45 - 12:45 CEST
Medical Device – International Focus: Global Reliance on CE Mark and Industry Strategies
Location: Studio 214 + 216 (level 2)
Moderator: Jennifer Neff, PhD – Entourage GmbH
Moderator: Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS – TÜV SÜD Medical Health Services
Speaker: Nada Alkhayat – European Commission
Speaker: Dennis Sarwin, MSc – Qserve Consultancy BV
Medical Devices
11:45 - 12:45 CEST
Orphaned Devices - The Needs, Approval Process and Challenges in the EU
Location: Gold Hall (level 0)
Moderator & Presenter: Tom Melvin, n.a. – Trinity College, Dublin
Speaker: Richard G. Holborow, n.a. (he/him/his) – BSI
Speaker: Leo Hovestadt – Elekta
Speaker: Nona Heueis, Phd (she/her/hers) – Heraeus Medical GmbH
Medical Devices
11:45 - 12:45 CEST
Using Artificial Intelligence to Support Regulatory Processes and Decision-Making
Location: Studio 211 + 212 (level 2)
Session Leader/Speaker: Agnes Dangy-Caye, Dr (she/her/hers) – Agnès Dangy-Caye, Regulatory Science and Policy, Sanofi
Speaker: Florian Lasch, PhD (he/him/his) – European Medicines Agency
Speaker: Daria Mari (she/her/hers) – regenold GmbH
Pharmaceuticals
12:45 - 13:30 CEST
Euro Convergence Farewell
Location: Magritte + Silver Foyer (level 0)