Full Schedule

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Wednesday, May 14, 2025
07:30 – 18:00 CEST
Cloakroom
Location: Glass Entrance (-1)
07:30 – 18:00 CEST
Registration
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
Presenter: Sue Spencer – Compliance Connextions Limited
Presenter: Pierre-Emmanuel Thiriet, Dr. (he/him/his) – Rea Diagnostics
Presenter: Diana Rosentul, PhD (she/her/hers) – Aiosyn
IVDs
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
Presenter: Yves Jacob (he/him/his) – Sanofi
Presenter: Steffen Thirstrup, MD, PhD (he/him/his) – European Medicines Agency (EMA)
Presenter: Lilia Luchianov – European Commission
Presenter: Nikos Dedes
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
Presenter: Ingela Mauritzon, MSc (she/her/hers) – Halmstad University
Presenter: Daniela Seneca, MEng (she/her/hers) – BSI
Presenter: Sebastian Fischer – TÜV SÜD Product Service GmbH
Medical Devices
08:30 – 09:30 CEST
MDR Kick-off Panel
Location: Gold Hall (level 0)
Moderator: Gert W. Bos, PhD FRAPS – QServe Group
Moderator: Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS – TÜV SÜD Medical Health Services
Panelist: Maria-Chiara Orlandi – European Commission
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
Presenter: Johnathan Akers, Masters of Clinical Research – QPS Holdings, LLC
Presenter: 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)
Presenter: Priya Paul, BS, MS, MS (she/her/hers) – RegDesk, Inc.
Solutions Circles
Supported by
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)
Presenter: 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)
Presenter: 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)
Presenter: Stuart Angell
Solutions Circles
09:40 – 10:10 CEST
Solutions Circle: The PFAS Paradox: Regulations, Testing, and Supply Chain Resilience
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Presenter: Lindsey Zocolo, n/a (she/her/hers) – Tuv Sud
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!
Presenter: 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!
Presenter: Andrea Seeck – Johner Institut GmbH
Presenter: 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!
Presenter: 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!
Presenter: Marcus Torr, MSci – Purdie Pascoe
Presenter: 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)
Presenter: 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)
Presenter: Amie Smirthwaite, BEng, PhD, FRAPS – RQM+
Solutions Circles
10:15 – 10:45 CEST
Solutions Circle: Structured Dialogue - IVDR - Live Example
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Presenter: 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)
Presenter: 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)
Presenter: Elisabeth Oltmanns, M.Sc. (she/her/hers) – Escentia GmbH
Presenter: Michael D'Agosto, Prof Dr (he/him/his) – Hochschule Furtwangen University
Presenter: 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)
Presenter: Sara Van Wouwe, RCC-IVDR (she/her/hers) – Qarad (part of the QbD Group)
Presenter: 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, SANOFI – SANOFI
Presenter: Cecil J. Nick, BSc (Hons) – Parexel
Presenter: Steffen Thirstrup, MD, PhD (he/him/his) – European Medicines Agency (EMA)
Presenter: Marija Pesic – Formycon
Pharmaceuticals
10:45 – 11:45 CEST
EU Variation Regulatory Reform – Creating Innovation in the Life-cycle Management
Location: The Arc (level 3)
Presenter: Agnes Dangy-Caye, Dr (she/her/hers) – Agnès Dangy-Caye, Regulatory Science and Policy, Sanofi
Presenter: Estelle A. Massoubre (she/her/hers) – Kenvue
Presenter: 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: Leo Louis, RAC, PMP – Royal Philips
Presenter: Yan Sheng, PhD – China Med Device, LLC
Presenter: Beat U. Steffen, MSc, RAC, FRAPS (he/him/his) – confinis ag
Presenter: Jenny Wu
Presenter: Monica Tavanti, PhD – CSL Behring
Medical Devices
10:45 – 11:45 CEST
The EU AI Act
Location: Gold Hall (level 0)
Presenter: Udo Heintz, PhD (he/him/his) – Ada Health GmbH
Presenter: Sarah Mathew – BSI
Presenter: Marco Caproni (he/him/his) – TUV SUD
Presenter: 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
Presenter: Alexander von Janowski, MSc – TÜV AI.Lab
Presenter: Natascha J. Cuper, PhD – Kiwa Dare
Presenter: Sabyne van Mourik, MBA RSE (she/her/hers) – Kiwa Nederland BV
Presenter: 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)
Presenter: Hilary Baldwin, n/a – Eximis Surgical
Presenter: Amra Racic – Veeva MedTech
Presenter: Gertjan Geelen, MSc – dsm-firmenich Biomedical
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)
Presenter: Antje Behring
Presenter: Michael Berntgen, PhD MDRA (he/him/his) – European Medicines Agency
Presenter: 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
Presenter: Mohamed-Salah Garouachi, PharmD – Constency Healthcare
Presenter: 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
Presenter: Yu Jin, MD, PhD (she/her/hers) – Notified Body 1639, SGS Belgium
Presenter: Yan Sheng, PhD – China Med Device, LLC
Presenter: 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
Presenter: Peter Fry – QbD Group
Presenter: Tasneem Keshavji
Presenter: James Crooks
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!
Presenter: Tibor Zechmeister, BSc MSc EMBA – Flinn.ai
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!
Presenter: 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)
Presenter: 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)
Presenter: 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)
Presenter: 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)
Presenter: 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!
Presenter: 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!
Presenter: 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)
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)
Presenter: 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)
Presenter: 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)
Presenter: Gert W. Bos, PhD FRAPS – QServe Group
Presenter: Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS – TÜV SÜD Medical Health Services
Solutions Circles
13:50 – 14:20 CEST
Solutions Circle: Real World Evidence Through Federated Learning (AI) - Monitor Drift and Local Optimization!
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Presenter: Abhineet Johri – Siemens healthineers
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!
Presenter: 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!
Presenter: Alexia Haralambous, MS, RAC – RQM+
Sponsored Presentations
Supported by
14:30 – 15:30 CEST
EU Green Deal
Location: Studio 211 + 212 (level 2)
Presenter: Erik R. Vollebregt – Axon Lawyers
Presenter: Sonja Hirte, PhD (she/her/hers) – PRO-LIANCE GLOBAL SOLUTIONS
Medical Devices
14:30 – 15:30 CEST
Accelerating Clinical Trials in EU
Location: The Arc (level 3)
Presenter: Laura Pioppo – EMA
Presenter: Rüdiger Faust, PhD – UCB
Pharmaceuticals
14:30 – 15:30 CEST
AI Sandboxes and Assurances
Location: Copper Hall (level 0)
Moderator: Celia Cruz, PhD (she/her/hers) – Complear
Presenter: Hannah Bowden, PhD (she/her/hers) – Medicines and Healthcare products Regulatory Agency
Presenter: Natasha Motsi, PhD (she/her/hers) – Medicines and Healthcare products Regulatory Agency
Presenter: Antonino Rotolo
Presenter: 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!
Presenter: 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, n/a – Akra Team Inc.
Presenter: Richard G. Holborow, n.a. (he/him/his) – BSI
Presenter: Ulrich Nitsche, MD, PhD (he/him/his) – TÜV SÜD Product Service GmbH
Presenter: Christoph Ziskoven (he/him/his) – TÜV Rheinland LGA Products GmbH
Medical Devices
14:30 – 15:30 CEST
Medicines Shortages
Location: Studio 214 + 216 (level 2)
Moderator: Michael Craig, n/a – Parexel
Presenter: Monica Dias, PhD (she/her/hers) – EMA
Presenter: Caroline De Bodt, PhD (she/her/hers) – UCB
Presenter: Anuja Shukla, MBA (she/her/hers) – UCB Pharma
Presenter: Pieter Jan Desiere – European Medicines Agency (EMA)
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)
Presenter: Margot Borgel, PhD – RQM+
Presenter: Edward Ball, CEng MIPEM (he/him/his) – RQM+
Presenter: Maddalena Pinsi, MSc – BSI
Presenter: 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: Speed without sacrifice: How RA Teams Turn Compliance into Competitive Advantage
Location: Exhibit Hall - 1. Spark!
Presenter: 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!
Presenter: 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!
Presenter: Priya Paul, BS, MS, MS (she/her/hers) – RegDesk, Inc.
Sponsored Presentations
Supported by
16:15 – 16:40 CEST
Veeva Systems U.K. Limited: Exploring the Ai-powered Future of Promotional Material Review
Location: Exhibit Hall - 2.Discover!
Presenter: Michael Konings – Philips
Presenter: Erik R. Vollebregt – Axon Lawyers
Presenter: Pearl Vyas – Veeva Systems
Presenter: Diogo Geraldes, PhD MEng – Veeva Systems
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 (she/her/hers) – European Medicines Agency (EMA)
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: Caterina Gozzi – European Commission
Panelist: Christelle Bouygues, PharmD – EMA
Panelist: Alberto Ganan, PhD – European Medicines Agency
Panelist: Suzanne Halliday, DPhil, FRAPS – BSI
18:00 – 21:00 CEST
Networking Dinner (ticket Required): Plein Publiek
Supported by