14th Annual Outsourcing in Clinical Trials: Medical Devices Europe 2026

Networking

Registration and refreshments

Other

Chairperson’s opening remarks

Fatima Bennai-Sanfourche, Bayer

Talk

Strengthening your trial strategy with HTA-aligned evidence

Leslie Pibouleau, European Commission Directorate-General for Health and Food Safety - SANTE · Alexandra Poulsson, Norwegian Medical Products Agency

Talk

From PMCF obligation to strategic advantage: standardising PMCF under EU MDR with 1Survey+

Enrico Perfler, 1MED

Talk

Adapting trial designs to global market realities

Manuela Stauss-Grabo, Fresenius Medical Care

Talk

AI in MedTech: redefining clinical trials and device development

Carol Stafford, Medidata · Akvile Lukose, Medidata

Break

Morning refreshments and networking

Panel · Stream A: Medical Device Trials & Evidence

Meeting Notified Body expectations for clinical data in 2026

Richard Holborow, BSI · Tonia Jeiter, Alcon · Ulrich Nitsche, TÜV SÜD · Dominic Tong, GlobalData · John Thomas, 1MED

Panel · Stream B: In Vitro Diagnostics Performance & Validation

Getting innovative devices approved in today’s regulatory landscape

Jens Pfannkuche, Penumbra · Manuela Stauss-Grabo, Fresenius Medical Care · Fatima Bennai-Sanfourche, Bayer

Talk · Stream A: Medical Device Trials & Evidence

Clinical evidence for AI-based medical devices

Andreas Beust, GCP-Service

Talk · Stream B: In Vitro Diagnostics Performance & Validation

Designing a smarter PMPF for intended purpose and performance claim evolution

Erin Gunduz, Signatur Bio

Talk · Stream A: Medical Device Trials & Evidence

Modernising global data collection for observational and registry studies

Katrin Simioni, AO Foundation

Talk · Stream B: In Vitro Diagnostics Performance & Validation

Single drug, multiple CDx: compliant trial and validation strategies

Philipp Schatz, Bayer

Break

Lunch and networking

Talk · Stream A: Medical Device Trials & Evidence

Navigating clinical compliance challenges in emerging medical device technologies

Richard Holborow, BSI

Talk · Stream B: In Vitro Diagnostics Performance & Validation

Navigating the new competent authority application process for companion diagnostics under IVDR

Sarah Johnson, QIAGEN

Talk · Stream A: Medical Device Trials & Evidence

Why medical device trials need a new EDC architecture

Florentin Ory, Datacapt

Talk · Stream B: In Vitro Diagnostics Performance & Validation

Inside the IVDR performance study review: competent authority insights and practical guidance

Nebojsa Serafimovic, Austrian Agency for Health and Food Safety

Talk · Stream A: Medical Device Trials & Evidence

Streamlining MedTech innovation: Eclevar’s specialized CRO meets Milo’s AI-driven efficiency

Sébastien Meier Piantanida, Eclevar

Talk · Stream A: Medical Device Trials & Evidence

Planning evaluations that withstand reclassification and scrutiny

Jie Jia, Fresenius Kabi

Break

Afternoon refreshments and networking and Prize Draw

Talk · Stream A: Medical Device Trials & Evidence

Simplifying PMCF with realistic and actionable strategies

Maike Hiller, Philips

Panel · Stream B: In Vitro Diagnostics Performance & Validation

Coordination assessment processes for medical devices and IVDs

Fatima Bennai-Sanfourche, Bayer · Marta Carnielli, TÜV SÜD

Talk · Stream A: Medical Device Trials & Evidence

From reactive compliance to continuous evidence: Taking back control of clinical data in medtech

Andreas Landsverk, Ledidi

Talk · Stream B: In Vitro Diagnostics Performance & Validation

Bridging legacy IVD devices to IVDR clinical expectations

Jens Pfannkuche, Penumbra

Other · Stream A: Medical Device Trials & Evidence

Q&A session: lessons learned from former Notified Body expert

Tonia Jeiter, Alcon · Dominic Tong, GlobalData

Other

Chairperson’s closing remarks

Fatima Bennai-Sanfourche, Bayer · Dominic Tong, GlobalData

Other

Chairperson’s opening remarks

Tina Deng, GlobalData

Talk

Aligning clinical trial execution with business objectives

Arne Böhling, Mölnlycke Healthcare

Talk

One device, two continents, two truths: an Asia-centric view of clinical evidence in Europe

Bhargav Joshi, Biotech Vision Care

Talk

Approved everywhere, paid nowhere; building evidence strategies that win both regulators and payers

Jaishankar Kutty, RQM+

Panel

Building and scaling clinical affairs teams with the right expertise

Stephan Theinert, FiberSense · Bhargav Joshi, Biotech Vision Care · Petra De Geest, QbD Group · Sarah Johnson, QIAGEN

Break

Morning refreshments and networking

Talk

Leveraging retrospective data for CE marking and robust clinical evaluation under MDR

Stephan Theinert, FiberSense

Talk

Clinical evaluation for product registration in China (comparison with same type devices)

Lianxu Hao, Care Real

Talk

Key considerations for medical device clinical investigation in China

Xu Li, Care Real

Break

Lunch and networking

Talk

Understanding the role of AI and cybersecurity throughout the medical devices lifecycle

David Bicknell, GlobalData · Sophie Gallagher, GlobalData

Talk

Choosing the right partner for clinical success

Autumn Lang, deepeye Medical

Break

Afternoon refreshments and networking and Prize Draw

Roundtable

Problem-Solving Roundtable Discussions

Talia Milosevic, Edwards Lifesciences · Stephan Theinert, FiberSense · Anna Mayer, TÜV SÜD · Luca Franceschini, Aboca · David Bicknell, GlobalData · Sophie Gallagher, GlobalData