Programme
08:00
Conference Opening & Welcome
Amie Smirthwaite - Conference Chair
09:00-10:30
Session 1: Panel: Setting the Stage: Regulation and Market Access
09:00-09:25
The Future of Medical Device Regulation and Clinical Evidence Requirements
![](https://horizon2024.com/wp-content/uploads/sites/137/2019/12/Picture-silhuete-man.jpg)
Paul Piscoi
European Commission, Brussels
09:25-09:50
Clinical Evidence Requirements for Medical Device Market Access
![](https://horizon2024.com/wp-content/uploads/sites/137/2024/06/michael_branagan.jpg)
Michael Branagan-Harris
Founder & CEO, Device Access, UK
![](https://horizon2024.com/wp-content/uploads/sites/137/2024/06/Mattias-Kyhlstedt.jpg)
Mattias Kyhlstedt
CEO and Founder, Synergus RWE, Sweden
09:50-10:15
Case Study: Balancing the Needs of Payers and Regulators to Maximise ROI
![](https://horizon2024.com/wp-content/uploads/sites/137/2024/06/Lisse-Lotte.jpeg)
Lisse-Lotte Hermansson
Chief Scientific Officer, Synergus, Switzerland
10:15-10:30
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
“Telling the Story”: Aligning your Clinical Strategy with Device Claims and Intended Purpose
![](https://horizon2024.com/wp-content/uploads/sites/137/2019/12/Picture-silhuete-man.jpg)
Andreas Stange
Senior Vice President, TÜV SÜD, Japan, Germany
11:20-11:40
Defining and Measuring “Clinical Benefit”
![](https://horizon2024.com/wp-content/uploads/sites/137/2019/12/Picture-silhuete-man.jpg)
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
![](https://horizon2024.com/wp-content/uploads/sites/137/2022/07/Picture-silhuete-female.jpg)
Sally Sennitt
Medical Director, RQM+,Belgium
12:00-12:20
Case Studies: Maximising Value of Clinical Evidence
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 (Part 1)
13:30-13:55
Clinical Study Costs – How Much does it Really Cost to Design and Execute a Study?
13:55-14:20
Transforming Ideals into Practicalities: Designing Studies That are Executable
![](https://horizon2024.com/wp-content/uploads/sites/137/2024/02/Helene-Quie_resized.jpg)
Helene Quie
Founder & CEO, Qmed Consulting, Denmark
14:20-14:45
Diversity in Clinical Investigations: Ensuring Appropriate Representation of your Intended Patient Population
14:45-15:00
Discussion / Q&A
15:00-15:30
Coffee Break, Networking & Visit the Exhibition
15:30-17:00
Session 4: Clinical Investigations: Practical Considerations (Part 2)
15:30-15:55
Geographical Considerations: Maximising Use of Global Data
15:55-16:20
Ethics and Informed Consent
16:20-16:45
Data Management and Analysis
16:45-17:00
Discussion / Q&A
17:00-18:00
Session 5: Demo of AI-Powered Documentation Management Tools
18:00
End of Day One
09:00-10:30
Session 6: Panel - Device-Specific Clinical Evidence Scenarios
09:00-09:25
AI-and SaMD
![](https://horizon2024.com/wp-content/uploads/sites/137/2024/06/frank-rademakers_resized.jpg)
Frank Rademakers
UZ KU Leuven, Belgium
09:25-09:50
Drug-Device Combinations
09:50-10:15
Diagnostic Devices
![](https://horizon2024.com/wp-content/uploads/sites/137/2024/06/Heike_resized.jpg)
Heike Moehlig-Zuttermeister
Head of IVD at TÜV Süd, Germany
10:15-10:35
Devices with no Direct Clinical Benefits
10:30-11:00
Coffee Break, Networking & Visit the Exhibition
11:00-12:30
Session 7: Panel - Regulatory, Quality and Compliance
11:00-11:20
Evolution of ISO 14155, ISO 18969 & GCP: Where are we Now?
![](https://horizon2024.com/wp-content/uploads/sites/137/2024/04/danielle-giroud-300_original_135x155.jpg)
Danielle Giroud
CEO, MD-Clinicals, Switzerland
11:20-11:40
Risk Management in the Clinical Evidence Feedback Loop
![](https://horizon2024.com/wp-content/uploads/sites/137/2024/06/Edd-Ball_resized.png)
Edward Ball
Manager, Intelligence and Strategic Execution at RQM+, UK
11:40-12:00
Clinical Investigation: Competent Authority Insights
![](https://horizon2024.com/wp-content/uploads/sites/137/2024/06/Nebojsa-Serafimovic-resized.jpg)
Nebojsa Serafimovic
Assessor Medical Devices, Senior Expert, AGES / Austrian Agency for Health and Food Safety, Austria
12:00-12:20
EU MDR: Key Updates with Respect to Clinical and Postmarket Requirements, Breakthrough and Orphan Devices
![](https://horizon2024.com/wp-content/uploads/sites/137/2024/04/Melvin-Tom.jpg)
Tom Melvin
Associate Professor of Medical Device Regulatory Affairs
Director, MSc Medical Device Regulatory Affairs, Ireland
12:20-12:30
Competing Regulations: AI Act, CTR, REACH and More
![](https://horizon2024.com/wp-content/uploads/sites/137/2024/04/Cecile-van-der-Heijden_resized.jpg)
Cécile van der Heijden
Advocaat / Attorney at law, Axon Lawyers, Netherlands
12:30-13:30
Lunch Break, Networking & Visit the Exhibition
13:30-15:00
Session 8: Maximising Value Through Outsourcing
13:30-13:55
Top Tips for Identifying and Qualifying Vendors
13:55-14:20
Building Trust Between Internal and External Partners to Ensure Project Success
14:20-14:45
Case Study: Outsourcing for Cost Effectiveness and Compliance
14:45-15:00
Discussion / Q&A
15:00-15:30
Coffee Break, Networking & Visit the Exhibition
15:30-17:20
Session 9: Completing the Loop: Postmarket Data and the Clinical Lifecycle
15:30-15:55
Building Trust Through Transparency: Benefits of Effective Post-Market Surveillance
![](https://horizon2024.com/wp-content/uploads/sites/137/2024/06/Ashley-Stratton-Powell.jpg)
Ashley Stratton-Powell
Senior Medical Device Specialist Orthopaedics, MHRA, UK
15:55-16:20
Medical Device Recalls, Prospective Methods to Monitor Device Lifetime and Trend Analyses
![](https://horizon2024.com/wp-content/uploads/sites/137/2024/06/Mattias-Kyhlstedt.jpg)
Mattias Kyhlstedt
CEO and Founder, Synergus RWE, Sweden
16:20-16:45
Case Study: from Reactive to Proactive – PMS and PMCF to Drive Innovation
16:45-17:10
Off-Label Use – Use Error or Unmet Clinical Need?
17:10-17:20
Discussion / Q&A
17:20
Closing Remarks