Full Schedule

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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