Full Schedule

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Wednesday, May 14, 2025
07:30 – 18:00 CEST
Cloakroom
07:30 – 18:00 CEST
Registration
08:30 – 09:30 CEST
America first – Europe second? Defining global market access strategies for start-ups and new devices
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?
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)
Pharmaceuticals
08:30 – 09:30 CEST
Innovating regulation: The use of AI by Notified Bodies for conformity assessment
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
Moderator: Gert W. Bos, MSc, PhD, FRAPS – Qserve Group
Moderator: Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS – TÜV SÜD Medical Health Services
Panelist: Caterina Gozzi – European Commission
Medical Devices
08:30 – 09:30 CEST
Regulatory Considerations for Gene Therapy in pediatric patients
Presenter: Johnathan Akers, Master of Clinical Research – QPS Holdings, LLC
Presenter: Giovanni Lesa, PhD – European Medicines Agency
Pharmaceuticals
08:30 – 09:30 CEST
Thriving on the Horizon of AI Medical Device Regulations in China
Presenter: Zhuo Li, MSc – Philips Healthcare
Presenter: Jacky Li, MSc – Cisema (Hong Kong) Limited
Software/AI/Cybersecurity
09:30 – 10:45 CEST
Presenters at Posters (Exhibition Hall)
09:30 – 10:45 CEST
Refreshment Break in the Exhibition Hall
09:40 – 10:10 CEST
Solutions Circle: Key Considerations for CDx in Combined Trials under IVDR
Presenter: Maham Ansari, MS, RAC – Precision for Medicine
Solution Circle
09:40 – 10:10 CEST
Solutions Circle: Mastering PSURs: Streamline Your Process for Faster Approvals
Presenter: Adam Kijowski, PhD – Geistlich Pharma AG
Solution Circle
09:40 – 10:10 CEST
Solutions Circle: The PFAS Paradox: Regulations, Testing, and Supply Chain Resilience
Presenter: Lindsey Zocolo, n/a (she/her/hers) – Tuv Sud
Solution Circle
09:45 – 10:45 CEST
Chapters and Local Networking Groups Meet and Greet
Location: Exhibit Hall
10:15 – 10:45 CEST
Solutions Circle: Points to consider in deciding on placebo/active comparators in clinical trials.
Presenter: Karl-Heinz Huemer, PhD MD (he/him/his) – khh consult
Solution Circle
10:15 – 10:45 CEST
Solutions Circle: Intended Use: The foundations of the medical device house
Presenter: Amie Smirthwaite, BEng, PhD, FRAPS – RQM+
Solution Circle
10:15 – 10:45 CEST
Solutions Circle: Structured Dialogue - IVDR - Live Example
Presenter: Tom Patten, n/a – GMED Certification Division
Solution Circle
10:15 – 10:45 CEST
Solutions Circle: Surviving the EHDS: A Lifeline
Presenter: Cecile E. van der Heijden (she/her/hers) – Axon Lawyers
Solution Circle
10:45 – 11:45 CEST
Addressing the Complexities of Using In Vitro Diagnostics (IVDs) in Global Clinical Trials.
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: Warren Jameson, Bsc, PhD, MTOPRA – NAMSA
IVDs
10:45 – 11:45 CEST
Clinical Evaluation 1
Presenter: Elisabeth Oltmanns, n/a – 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
EU Variation Reform + Worksharing
Presenter: Agnes Dangy-Caye, Dr – Agnès Dangy-Caye, Regulatory Science and Policy, Sanofi
Presenter: Estelle A. Massoubre (she/her/hers) – Kenvue
Pharmaceuticals
10:45 – 11:45 CEST
Global Perspectives on Usability and Human Factors Studies in Regulatory Submissions: Navigating the US, EU, and China Landscape
Presenter: Zoe Deng, RAC, Certified ISO 13485 Lead Auditor – Accel Groups
Presenter: Yan Sheng, PhD – China Med Device, LLC
Medical Devices
10:45 – 11:45 CEST
Streamlining Biosimilar Development Based on 20 Years’ Experience
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
The EU AI Act
Presenter: Udo Heintz, PhD (he/him/his) – Ada Health GmbH
Presenter: Sarah Mathew – BSI
Presenter: Marco Caproni, n/a (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
Artificial Intelligence - Testbeds
Presenter: Alexander von Janowski, MSc – TÜV AI.Lab
Presenter: Natascha J. Cuper, PhD – Kiwa Dare
Presenter: Sabyne van Mourik, n/a – Kiwa Nederland BV
Software/AI/Cybersecurity
12:00 – 13:00 CEST
Changes in U.S. Politics: Implications for Submissions and Agency Collaboration
Presenter: Hilary Baldwin, n/a – Eximis Surgical
Presenter: Amra Racic – Veeva Systems
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
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
Presenter: Anca-Sarmiza Gültekin-Tigan, Dr / MSc (she/her/hers) – QUAREGIA GmbH
Presenter: Marta Carnielli, n/a – TUV Sud GmbH
Presenter: Mohamed-Salah Garouachi, n/a – Constency Healthcare
IVDs
12:00 – 13:00 CEST
Maximizing the value of clinical data for global submissions (EU/China)
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
Presenter: Peter Fry, n/a – QbD Group
Pharmaceuticals
13:00 – 14:30 CEST
Networking Lunch in Exhibition Hall
13:10 – 13:35 CEST
Sponsored presentations - Round 1
13:15 – 13:45 CEST
Solutions Circle: ’Growing pains’: an evaluation of evolving pediatric study regulation in the US and EU
Presenter: Sarah Arden, PhD – AstraZeneca
Solution Circle
13:15 – 13:45 CEST
Solutions Circle: Decreasing Complexity, defining Regulatory and Evaluation Strategy of LLM based functions.
Presenter: Emilie Santos, PhD (she/her/hers) – Philips Healthcare
Solution Circle
13:15 – 13:45 CEST
Solutions Circle: Impact of the Battery Regulation (EU) 2023/1542 on medical devices
Presenter: Christoph Kiesselbach (he/him/his) – Schrack & Partner
Solution Circle
13:15 – 13:45 CEST
Solutions Circle: Key takeaways from 4 years of expert panel views to improve your IVD evaluation
Presenter: Beatriz Rodriguez Grande, PhD – NAMSA
Solution Circle
13:30 – 14:15 CEST
RAPS Speed Mentoring
Location: Exhibit Hall
13:40 – 14:05 CEST
Sponsored presentations - Round 2
13:50 – 14:20 CEST
Solutions Circle: Challenges related to Data in AI Medical Devices in the European Union
Presenter: Liliana Teles, PharmD, Msc (she/her/hers) – CRITICAL CATALYST
Solution Circle
13:50 – 14:20 CEST
Solutions Circle: Cybersecurity in premarket submissions: US vs. EU approach
Presenter: Taly Vider Cohen – MES Medical Electronic Systems
Solution Circle
13:50 – 14:20 CEST
Solutions Circle: Insight in Motivation: The RA life stories that matter in healthcare
Presenter: Gert W. Bos, MSc, PhD, FRAPS – Qserve Group
Presenter: Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS – TÜV SÜD Medical Health Services
Solution Circle
13:50 – 14:20 CEST
Solutions Circle: Real world evidence through Federated learning (AI) - Monitor drift and local optimization!
Presenter: Abhineet Johri, n/a – Siemens
Solution Circle
14:05 – 14:30 CEST
Sponsored presentations - Round 3
14:30 – 15:30 CEST
EU Green Deal
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
Presenter: Laura Pioppo – EMA
Pharmaceuticals
14:30 – 15:30 CEST
Clinical data challenges for novel and legacy medical devices - panel discussion with clinical experts from multiple notified bodies
Presenter: Matthias Fink – Akra Team Inc.
Presenter: Richard G. Holborow, n.a. (he/him/his) – BSI Group
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
Establishing AI Assurance: Establishing Laboratory and Testing Facilities in the EU and US
Moderator: Celia Cruz, PhD (she/her/hers) – Complear
Panelist: Florian Lasch, PhD (he/him/his) – European Medicines Agency
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
Software/AI/Cybersecurity
14:30 – 15:30 CEST
Medicines Shortages
Presenter: Monica Dias, PhD (she/her/hers) – 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
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)
15:30 – 16:45 CEST
Refreshment Break in the Exhibition Hall
15:45 – 16:10 CEST
Sponsored presentations - Round 1
16:15 – 16:40 CEST
Sponsored presentations - Round 2
16:45 – 18:00 CEST
Conversations That Matter: Interactions with Health Authorities
Moderator: Sabine Haubenreisser, MSc, PhD (she/her/hers) – 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: Caterina Gozzi – European Commission
Panelist: Christelle Bouygues, PharmD – EMA
Panelist: Alberto Ganan, PhD – European Medicines Agency
19:00 – 22:00 CEST
Networking Dinner (ticket required): Plein Publiek