Program

09:00

Conference Opening & Welcome

Amie Smirthwaite, RQM | Conference Chair

09:20-10:30

Session 1: Panel - Setting the Stage: Regulatory, Clinical and Market Access Planning

09:20-09:40

“Telling the Story”: Ensuring Clinical Evidence is Aligned with Device Claims and Intended Purpose – a Regulator’s Perspective

Mette Sørensen

Internal Clinician, TÜV SÜD, Denmark

09:40-10:00

Clinical Evidence Requirements for Medical Device Market Access

Michael Branagan-Harris

Founder & CEO, Device Access, UK

10:00-10:20

Balancing the Needs of Payers and Regulators to Maximise ROI

Mattias Kyhlstedt

CEO and Founder, Synergus RWE, Sweden

10:20-10:30

Discussion / Q&A

10:30-11:00

Coffee Break, Networking & Visit the Exhibition

11:00-12:30

Session 2: Diving Deeper - Clinical Evidence Requirements and Strategies

11:00-11:20

Case Study: Intended Purpose as the Driver - Linking User Needs to Clinical Evidence Requirements

Josh Bridgens

European Medical Director for J&J Medtech, UK

11:20-11:40

Defining and Measuring “Clinical Benefit”

Richard Holborow

Global Head Clinical Compliance, BSI, UK

11:40-12:00

State of the Art – the Research-Based Glue that Binds Design, Risk, Clinical and Post-Market Together

Sally Sennitt

Medical Director, RQM+, Belgium

12:00-12:20

Digitalization of Clinical Evidence and a Unified Data Model for Regulatory Processes

Sarah Panten

Co-Founder, Medical Device Knowledge Unit (MDKU), Germany

12:20-12:30

Discussion / Q&A

12:30-13:30

Lunch Break, Networking & Visit the Exhibition

13:30-15:00

Session 3: Clinical Investigations: Practical Considerations

13:30-13:50

Clinical Study Costs – How Much does it Really Cost to Design and Execute a Study?

Salvinia Mletzko

Associate Director Project Management, RQM+, Germany

13:50-14:10

Transforming Ideals into Practicalities: Designing Studies That are Executable

Helene Quie

Founder & CEO, Qmed Consulting, Denmark

14:10-14:30

Clinical Trials and Innovation - Is the Momentum Swinging Back to Europe?

John Kilmartin

Medtech Regulatory Consultant & Adjunct Professor, University of Galway (Inst. for Clinical Trials), Ireland

14:30-14:50

Registry Studies: Common Pitfalls and the Solutions

Oge Swaby

Principal Business Consultant at NEC Software Solutions, UK

14:50-15:00

Discussion / Q&A

15:00-15:30

Coffee Break - Sponsored by Evnia

15:30-17:00

Session 4: Alternative Study Design for Post Market Data Collection

15:30-15:50

Aligning PMCF Planning and Data Requirements with Clinical Evaluation Outputs

Breda Kearney

Clinical Regulatory Lead, Global Regulatory Compliance Team, BSI Group, Ireland

15:50-16:10

Innovative Use of EDC for Direct to Patient Data Collection

Ewa Lindqvist

Director, THREAD Research

16:10-16:30

Case Study: Effective Use of Surveys for PMCF Data Collection

John McDonald

Senior Director Clinical Evidence Generation, Teleflex, Ireland

16:30-16:50

Use of AI for Enhanced Real World Data Collection (

Pre-Recorded)

Bethany Chung

Senior Manager, Technical, RQM+, USA

16:50-17:00

Discussion / Q&A

17:00-17:45

Session 5: Demo on AI-Powered Clinical and Technical Documentation Management

Sara Contu, Digital solutions, Product Manager at Giotto.ai, Switzerland

17:45

End of Day One

08:30

Registration

09:00-10:30

Session 6: Software and IVDs

09:00-09:45

AI-and SaMD – Evidence Requirements, Strategies and Common Pitfalls in Software Study Designs

Prof. Frank Rademakers

UZ KU Leuven, Belgium

Ankeet Tanna

Consultant, Hardian Health, UK

09:45-10:10

Clinical Evidence Requirements for Diagnostic Devices

Heike Möhlig-Zuttermeister

Global Director in-vitro Diagnostics (IVD) at Tüv Süd, Germany

10:10-10:30

Use of EQA Data for IVD Performance Evaluation

Stuart Angell

Managing Director, IVDeology, UK

10:30-11:00

Coffee Break, Networking & Visit the Exhibition

11:00-12:30

Session 7: Regulatory, Quality and Compliance (part 1)

11:00-11:20

EU MDR: Key Updates with Respect to Clinical and Postmarket Requirements (

Pre-Recorded)

Paul Piscoi

European Commission, Belgium

11:20-11:50

Evolution of ISO 14155, ISO 18969 & GCP: Where are we Now?

Danielle Giroud

CEO, MD-Clinicals, Switzerland

11:50-12:20

Risk Management in the Clinical Evidence Feedback Loop

Edward Ball

Manager, Intelligence and Strategic Execution at RQM+, UK

12:20-12:30

Industry Spotlight Sponsored by Evnia

12:20-12:30

Regulatory and Clinical Strategy as a Catalyst for Healthcare Innovation and Market

Dr. Vicky Valla (Ph.D., M.A., DipTrans)

Regulatory Compliance Lead, Evnia, Denmark

12:30-13:30

Lunch Break, Networking & Visit the Exhibition

13:30-15:00

Session 8: Regulatory, Quality and Compliance (part 2)

13:30-13:50

Clinical Investigation: Competent Authority Insights

Nebojsa Serafimovic

Assessor Medical Devices, Senior Expert, AGES / Austrian Agency for Health and Food Safety, Austria

13:50-14:10

Competing Regulations: AI Act, CTR, REACH and More

Cécile van der Heijden

Advocaat / Attorney at law, Axon Lawyers, Netherlands

14:10-14:30

Global Challenges and Successes: a Manufacturer Perspective

Anna Bertilsson

Senior Director, Integra Life Sciences, Sweden

14:30-14:50

Building Trust Through Transparency: Benefits of Effective Post-Market Surveillance

Ashley Stratton-Powell

Expert Assessor at the MHRA, UK

14:50-15:00

Discussion / Q&A

15:00-15:30

Coffee Break, Networking & Visit the Exhibition

15:30-17:00

Session 9: Completing the Loop - Postmarket Data and the Clinical Lifecycle

15:30-15:50

Off-Label Use – Use Error or Unmet Clinical Need?

Breda Kearney

Clinical Regulatory Lead, Global Regulatory Compliance Team, BSI Group, Ireland

15:50-16:10

Real-World Evidence that Makes a Difference in Regulatory and Reimbursement Decisions

Mattias Kyhlstedt

CEO and Founder, Synergus RWE, Sweden

16:10-16:30

From Reactive to Proactive – PMS and PMCF to Drive Innovation - Case 1

Ella Helgeman

Director, Regulatory Affairs and Quality Assurance, Rehaler, Denmark

16:30 -16:50

From Reactive to Proactive – PMS and PMCF to Drive Innovation - Case 2

Efstathios Vassiliadis

CEO, Evnia, Denmark

16:50-17:00

Discussion / Q&A

17:00

Closing Remarks

Amie Smirthwaite, RQM | Conference Chair