Full Schedule

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Tuesday, May 13, 2025
07:30 – 18:00 CEST
Cloakroom
07:30 – 18:00 CEST
Registration
08:30 – 16:00 CEST
Pre-Conference Workshop: Clinical Evaluation - Optimizing Clinical Data and State-of-the-Art Searches for MDR Compliance
Presenter: Paul John Risborough, BEng Hons – NAMSA
Presenter: Christiane Reinwald – be-on-Quality GmbH
Presenter: Mette Stoedter, PhD (Dr rer medic) (she/her/hers) – be-on-Quality GmbH
WorkshopMedical Devices
08:30 – 16:00 CEST
Preconference Workshop: AI - Your Best Buddy on the Path to Regulatory Compliance
Presenter: Florian Tolkmitt, n/a – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Presenter: Stephen Gilbert, PhD (he/him/his) – Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Presenter: Sarai Pahla, Bachelors Degree in Medicine and Surgery, Masters Degree in Regulatory Affairs – CriterionEdge, self-employed
WorkshopSoftware/AI/Cybersecurity
08:30 – 16:00 CEST
Preconference Workshop: EU Pharmaceutical Regulatory Reform
Workshop Leader: Rebecca Lumsden, PhD (she/her/hers) – Sanofi
Presenter: Yves Jacob (he/him/his) – Sanofi
Presenter: Alberto Ganan, PhD – European Medicines Agency
WorkshopPharmaceuticals
08:30 – 16:00 CEST
Preconference Workshop: From Concept to Compliance: Overcoming the Regulatory Challenges of Clinical Performance Studies
Presenter: Natalie Batty, MPH – Aignostics
Presenter: Marina Belonogova, PhD – Johnson and Johnson
Presenter: Kristiane Schmidt, PhD (she/her/hers) – Qserve Consultancy BV
WorkshopIVDs
08:30 – 16:00 CEST
Preconference Workshop: IVDR Technical Documentation
Moderator: Marta Carnielli, n/a – TUV Sud GmbH
Presenter: Tom Patten, n/a – GMED Certification Division
Presenter: Catherine Holzmann, N/A – GMED Certification Division
Presenter: Alex Laan, Dipl.-Ing. (he/him/his) – BSI
Presenter: Marco Caproni, n/a (he/him/his) – TUV SUD
WorkshopIVDs
08:30 – 16:00 CEST
Preconference Workshop: PMS process- Dos and Don'ts
Presenter: Vaso Basinou, n/a – Freelancer
Presenter: Ivan Stoyanov, Dr. – SGS Notified Body, 1639
Presenter: Andrea Biasiucci, PhD – confinis
Presenter: Claudio Alberti – Confinis
WorkshopMedical Devices
16:30 – 18:30 CEST
Euro Convergence 2025 Welcome and Opening Plenary
18:30 – 19:30 CEST
Opening Reception in Exhibit Hall
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
Thursday, May 15, 2025
07:30 – 18:00 CEST
Cloakroom
07:30 – 18:00 CEST
Registration
08:30 – 09:30 CEST
Cybersecurity Across the Medical Device Lifecycle: Addressing Modern and Legacy Products
Presenter: Julian Alpers, PhD (he/him/his) – seleon GmbH
Presenter: Kevin Veldman – Kiwa
Presenter: Pieter Smits – QbDGroup
Software/AI/Cybersecurity
08:30 – 09:30 CEST
EU Green Deal inc OSOA, UWWTD
Speaker: Veronika Jekerle, PhD – European Medicines Agency
Pharmaceuticals
08:30 – 09:30 CEST
EUDAMED unlocked: Navigating the current Landscape and Implementation Strategies
Presenter: Patrick Pille, Dr – MDSS GmbH
Presenter: Richard Houlihan, MBA BSc – EirMed Ltd
Medical Devices
08:30 – 09:30 CEST
Large panel genomic profiling and IVDR: strategies for manufacturers
Presenter: Steven Van Hove (he/him/his) – QbD Group
Presenter: Annelies Rotthier, n/a – Qarad (part of the QbDGroup)
Presenter: Pieter C. Bogaert, PhD (he/him/his) – Qarad (part of QbD Group)
Presenter: James Kerr – BSI
IVDs
08:30 – 09:30 CEST
Reliance pathways such as WHO Collaborative Registration Procedure (CRP) to accelerate the assessment and registration of medicinal products
Presenter: Merce Caturla Goni, PhD (she/her/hers) – Alexion Astra Zeneca Rare Diseases
Presenter: 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?!
Moderator: Robert A. van Boxtel – Medical Device Project B.V.
Presenter: Sarah Panten – avasis solutions GmbH / Medical Device Knowledge Unit e.V.
Presenter: Alexej Agibalow, n/a – Escentia GmbH
Presenter: Markus Poettker, n/a (he/him/his) – Smith&Nephew
Medical Devices
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: ’Growing pains’: an evaluation of evolving pediatric study regulation in the US and EU
Presenter: Sarah Arden, PhD – AstraZeneca
Solution Circle
09:40 – 10:10 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
09:40 – 10:10 CEST
Solutions Circle: Impact of the Battery Regulation (EU) 2023/1542 on medical devices
Presenter: Christoph Kiesselbach (he/him/his) – Schrack & Partner
Solution Circle
09:40 – 10:10 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
10:15 – 10:45 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
10:15 – 10:45 CEST
Solutions Circle: Cybersecurity in premarket submissions: US vs. EU approach
Presenter: Taly Vider Cohen – MES Medical Electronic Systems
Solution Circle
10:15 – 10:45 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
10:15 – 10:45 CEST
Solutions Circle: Real world evidence through Federated learning (AI) - Monitor drift and local optimization!
Presenter: Abhineet Johri, n/a – Siemens
Solution Circle
10:45 – 11:45 CEST
Digital Transformation
Presenter: Solange Corriol-Rohou, MD, PhD (she/her/hers) – AstraZeneca
Presenter: Ali Hansford, PhD (she/her/hers) – Accumulus Synergy
Presenter: Aleksandra Dacic – European Medicines Agency (EMA)
Pharmaceuticals
10:45 – 11:45 CEST
Navigating IVDR: Performance Evaluation and Usability for Near-Patient and Self-Tests
Presenter: Margot Borgel, PhD – RQM+
Presenter: Sara Peeters, PhD (she/her/hers) – QbD
Presenter: 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)
Presenter: Catarina Carrão – BioSciPons
Presenter: Zuzanna Kwade, MSc, PhD. (she/her/hers) – Dedalus Healthcare
Presenter: Anastasia Chalkidou
Software/AI/Cybersecurity
10:45 – 11:45 CEST
Patient-focused Drug Development in EU: From EPAR to SmPC?
Presenter: Amaia Clemente, Pharmacist – Sanofi
Presenter: Kaisa Immonen
Pharmaceuticals
10:45 – 11:45 CEST
Revolutionizing product safety and performance: The Role of Computational Modelling, In Silico Trials, and Global Standards
Presenter: Gavin Quigley, MBChB FRCS MBA – British Standards Institution
Presenter: Alejandro Federico Frangi, FREng FIEEE – University of Manchester
Presenter: Jeff Bischoff, PhD – Zimmer Biomet
Presenter: Michael Kipping, PhD – Element Materials Technology | University of Manchester
Medical Devices
10:45 – 11:45 CEST
UK Regulatory Landscape: UK MDR Amendments and Impact
Moderator: Sue Spencer – Compliance Connextions Limited
Presenter: Monisha Phillips, n/a (she/her/hers) – TUV SUD
Presenter: Vishal Thakker, MEng (he/him/his) – BSI
Presenter: Robert Reid (he/him/his) – MHRA
Medical Devices
12:00 – 13:00 CEST
CMC strategy / ICH Q9
Presenter: 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
Presenter: Darius-Jean Namdjou, PhD – Phortas GmbH
Presenter: Peter Kiely – Parexel
Pharmaceuticals
12:00 – 13:00 CEST
Mastering US FDA Cybersecurity Submissions: Requirements, Deficiencies, and Best Practices
Presenter: Rene' Hardee (she/her/hers) – MedSec
Presenter: Matthew Hazelett
Software/AI/Cybersecurity
12:00 – 13:00 CEST
Navigating Pitfalls in Clinical Performance Studies: CRO Insights on Sample Management and Ethical Considerations
Presenter: Jörg Hollidt
Presenter: Sven Hoffmann, MSc (he/him/his) – Entourage GmbH
IVDs
12:00 – 13:00 CEST
Navigating the intersection of MDR and HTA: Strategic implications for medical device manufacturers
Presenter: thomas miramond – NAMSA
Presenter: Andrea Rappagliosi
Medical Devices
12:00 – 13:00 CEST
PSUR: Requirements, experiences and lessons learned to date from three stakeholder perspectives
Presenter: Jenifer E. Hannon, N/A, MTOPRA – BSI
Presenter: Sietske Eerens (she/her/hers) – Dutch Health and Youth Care Inspectorate (IGJ)
Presenter: Markus Poettker, n/a (he/him/his) – Smith&Nephew
Medical Devices
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: Intended Use: The foundations of the medical device house
Presenter: Amie Smirthwaite, BEng, PhD, FRAPS – RQM+
Solution Circle
13:15 – 13:45 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
13:15 – 13:45 CEST
Solutions Circle: Structured Dialogue - IVDR - Live Example
Presenter: Tom Patten, n/a – GMED Certification Division
Solution Circle
13:15 – 13:45 CEST
Solutions Circle: Surviving the EHDS: A Lifeline
Presenter: Cecile E. van der Heijden (she/her/hers) – Axon Lawyers
Solution Circle
13:40 – 14:05 CEST
Sponsored presentations - Round 2
13:50 – 14:20 CEST
Solutions Circle: Key Considerations for CDx in Combined Trials under IVDR
Presenter: Maham Ansari, MS, RAC – Precision for Medicine
Solution Circle
13:50 – 14:20 CEST
Solutions Circle: Mastering PSURs: Streamline Your Process for Faster Approvals
Presenter: Adam Kijowski, PhD – Geistlich Pharma AG
Solution Circle
13:50 – 14:20 CEST
Solutions Circle: The PFAS Paradox: Regulations, Testing, and Supply Chain Resilience
Presenter: Lindsey Zocolo, n/a (she/her/hers) – Tuv Sud
Solution Circle
14:05 – 14:30 CEST
Sponsored presentations - Round 3
14:30 – 15:30 CEST
Benefits of standardized data models for digitalization in the Medtech industry
Presenter: Sarah Panten – avasis solutions GmbH / Medical Device Knowledge Unit e.V.
Presenter: Daniel Prell, n/a – Siemens Healthineers AG
Presenter: 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)
Moderator: Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting
Presenter: Piritta M. Maunu (she/her/hers) – PharmaLex Finland
Presenter: Natalie Batty, MPH – Aignostics
Presenter: Christelle Bouygues, PharmD – EMA
Pharmaceuticals
14:30 – 15:30 CEST
ML-based Medical Devices on General Purpose Wearable Hardware
Presenter: Vivek Thakkar, Master Degree in Medical Device and Diagnostic Engineering – Meta
Software/AI/Cybersecurity
14:30 – 15:30 CEST
Navigating Mergers and Acquisitions: Transitioning Products from IVDD/MD to IVDR/MDR Compliance"
Presenter: Rachel Ryll, MBA, CQA, CMQ/OE (she/her/hers) – Calibre Scientific
IVDs
14:30 – 15:30 CEST
Scientific Advice EU & US
Presenter: Simona Stankeviciute – Parexel
Presenter: Hagit Marchaim, PhD (she/her/hers) – Dr. Hagit Marchaim RA Consulting (HMC-regulation)
Presenter: Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency
Presenter: Christophe Lahorte – FAGG - Federal agency for medicines and health products (Belgium)
Pharmaceuticals
14:30 – 15:30 CEST
Using IMDRF codes to analyse complaints and connections with Risk Management
Presenter: Keith Morel, Ph.D. (he/him/his) – Qserve
Presenter: Gregory Duby
Medical Devices
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 – 17:45 CEST
Bilateral benefit of structured dialogues between Manufacturers and Notified Bodies
Presenter: Ana Matos Machado, MD – Tuv Sud
Presenter: Javier Castillo, MSc EMBA (he/him/his) – INBRAIN Neuroelectronics
Presenter: Alberto Ganan, PhD – European Medicines Agency
Medical Devices
16:45 – 17:45 CEST
China: Key Regulatory & Clinical Updates and their Implementation
Presenter: Grace F. Palma, MBA (she/her/hers) – China Med Device
Presenter: Hamish King, LLB, RAC – Cisema
Presenter: Xiaowei Sun
Medical Devices
16:45 – 17:45 CEST
Critical IVDR milestones & EU Reference Laboratories… a testing time
Presenter: Erica Conway, BSc, PhD (she/her/hers) – GSK
Presenter: Andreas Stange, n/a (he/him/his) – TÜV SÜD
Presenter: Goran Abdurrahman, PhD (he/him/his) – TÜV Rheinland
IVDs
16:45 – 17:45 CEST
EMA and FDA programs to support innovation and unmet medical needs.
Presenter: Hagit Marchaim, PhD (she/her/hers) – Dr. Hagit Marchaim RA Consulting (HMC-regulation)
Presenter: Kristina Larsson, MSc – European Medicines Agency
Pharmaceuticals
16:45 – 17:45 CEST
Evolving with Technology: Navigating Current Regulatory Challenges and Future Directions in IoMT Cybersecurity
Presenter: Oscar Freyer (he/him/his) – Else Kröner Fresenius Center for Digital Health,TUD Dresden University of Technology
Presenter: Julian Alpers, PhD (he/him/his) – seleon GmbH
Presenter: Pascal Werner, M.Sc. – Ostrich Consulting LLC
Presenter: Alexander Stock, PhD (he/him/his) – TÜV SÜD
Software/AI/Cybersecurity
16:45 – 17:45 CEST
RWE
Presenter: Rüdiger Faust, PhD – UCB
Presenter: Cecil J. Nick, BSc (Hons) – Parexel
Panelist: Andrej Segec, MPharm MSc – European Medicines Agency
Pharmaceuticals
Friday, May 16, 2025
07:30 – 14:00 CEST
Cloakroom
07:30 – 14:00 CEST
Registration
08:30 – 10:00 CEST
Plenary Session - Disruptive Innovation: Redefining Regulatory Roles
10:00 – 10:30 CEST
Refreshment Break
10:30 – 11:30 CEST
All in one for Biocompatibility: ISO 10993 Updates, Toxicological Risk Assessment and Post-Market Data
Presenter: Marina Daineko, MSc (she/her/hers) – Intrinsic Medical Group
Presenter: alessia frabetti, PhD (she/her/hers) – Kiwa Cermet Italia SPA
Presenter: Jeremy Tinkler, ERT – ICON plc
Medical Devices
10:30 – 11:30 CEST
China drug regulatory pathways: 2025 Key Updates and Deep-Dive
Presenter: Hamish King, LLB, RAC – Cisema
Pharmaceuticals
10:30 – 11:30 CEST
Mastering Post-Market Surveillance under IVDR: From PMPF to PSUR
Presenter: Liz Gommans, PhD (she/her/hers) – DEKRA B.V.
Presenter: Goran Abdurrahman, PhD (he/him/his) – TÜV Rheinland
Presenter: 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
Presenter: Edward Ball, CEng MIPEM (he/him/his) – RQM+
Medical Devices
10:30 – 11:30 CEST
Risk Management Approaches
Presenter: Sebastian Fischmeister, MASc, PhD, PEng (he/him/his) – University of Waterloo
Presenter: Stefan Braun, MSc, Automotive Cybersecurity Professional (lvl2), Provisional Assessor Automotive – FSQ
Presenter: Ben Kokx – Philips
Software/AI/Cybersecurity
10:30 – 11:30 CEST
Shaping the Future of mRNA Vaccines: A Regulatory Perspective
Presenter: Mohamad Toutounji (he/him/his) – Molgenium
Presenter: Thomas Larsson, MSc, BSc – European Medicines Agency
Pharmaceuticals
11:45 – 12:45 CEST
Adaptive and Evolving AI-enabled Medical Devices
Presenter: Koen Cobbaert (he/him/his) – Philips
Presenter: Stephen Gilbert, PhD (he/him/his) – Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Presenter: Eric Henry, BS – King & Spalding LLP
Software/AI/Cybersecurity
11:45 – 12:45 CEST
Device - Drug Borderlines – challenges in Europe and the USA
Presenter: Jane L. Arnold-Round, B.Eng Msc. – NAMSA
Presenter: Ortzi OLASOLO – Beyond Conception GmbH
Presenter: Alberto Ganan, PhD – European Medicines Agency
Pharmaceuticals
11:45 – 12:45 CEST
Dynamic Regulatory Assessment: how AI can increase efficiency in phased reviews
Presenter: Agnes Dangy-Caye, Dr – Agnès Dangy-Caye, Regulatory Science and Policy, Sanofi
Presenter: Florian Lasch, PhD (he/him/his) – European Medicines Agency
Pharmaceuticals
11:45 – 12:45 CEST
Involving European Reference Laboratories in the conformity assessment of Class D IVD's: Operational update after 6 months.
Moderator: Kirsten Van Garsse, RCC-IVDR (she/her/hers) – Qarad (Part of the QbD Group)
Presenter: Alex Laan, Dipl.-Ing. (he/him/his) – BSI
Presenter: Jennifer Rosendahl, PhD. (she/her/hers) – RISE
Presenter: Angela Filomena, Dr (she/her/hers) – Paul-Ehrlich-Institut
Presenter: Katja Mierish, PhD. – Tuv Rheinland
IVDs
11:45 – 12:45 CEST
Medical device - International focus
Medical Devices
11:45 – 12:45 CEST
Orphaned devices - the needs, approval process and challenges in the EU.
Moderator: Tom Melvin, n.a. – Trinity College, Dublin
Presenter: Richard G. Holborow, n.a. (he/him/his) – BSI Group
Presenter: Leo Hovestadt, n.a – Elekta
Presenter: Nona Heueis, Phd (she/her/hers) – Heraeus Medical GmbH
Medical Devices