The International Conference on

Clinical Investigations, Regulation and Market Access for Medical Devices and IVDs

Member of

20-21 November, 2024
Copenhagen, Denmark

Dear Colleagues,​

It is our great pleasure to welcome you to The International Conference on Clinical Investigations, Regulation and Market Access for Medical Devices and IVDs (Horizon 2024) that will take place in Copenhagen, 20-21 November 2024.

The bar for clinical evidence for medical devices and IVDs to gain and maintain market access has never been greater. Regulators globally require a higher level of precision and granularity for clinical data to demonstrate safety and performance, in some cases even for well-established devices which have a long market history. Additionally, evolution in technology, drivers for demonstration of cost effectiveness of treatments, and increasing focus on ethical issues such as health equity pose challenges in terms of developing the right regulatory and clinical strategy.

This conference will examine the interplay between regulatory science, demonstration of device safety and performance, and development of an effective pre-and post- market clinical evidence strategy. It will also address critical operational issues including data management, statistics, cost effective study design, outsourcing, reimbursement planning and more.

The event is designed for regulatory and clinical leaders and decision makers in the medical device and IVD industry. Meet your colleagues and distinguished experts in clinical trials, reimbursement, regulations, and data management to share your thoughts, discuss hot topics and learn from each other.

We look forward to meeting you at The International Conference on Clinical Investigations, Regulation and Market Access for Medical Devices and IVDs (Horizon 2024)

Sincerely,  

Amie Smirthwaite PhD, FRAPS
Conference Chair

MEET OUR
SPEAKERS

Speaker Image
Stuart Angell

Managing Director, IVDeology, UK

Speaker Image
Edward Ball

Manager, Intelligence and Strategic Execution at RQM+, UK

Speaker Image
Anna Bertilsson

Senior Director, Integra Life Sciences, Sweden

Speaker Image
Michael Branagan-Harris

Founder & CEO, Device Access, UK

Speaker Image
Josh Bridgens

European Medical Director for J&J Medtech, UK

Speaker Image
Bethany Chung

Senior Manager, Technical, RQM+, USA

Speaker Image
Sara Contu

Product Manager for Fern.ai, Giotto.ai, Switzerland

Speaker Image
Danielle Giroud

CEO, MD-Clinicals, Switzerland

Speaker Image
Ella Helgeman

Director, Regulatory Affairs and Quality Assurance, Rehaler, Denmark

Speaker Image
Richard Holborow

Global Head Clinical Compliance, BSI, UK

Speaker Image
Breda Kearney

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

Speaker Image
John Kilmartin

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

Speaker Image
Ewa Lindqvist

Director, THREAD Research

Speaker Image
Mattias Kyhlstedt

CEO and Founder, Synergus RWE, Sweden

Speaker Image
John McDonald

Senior Director Clinical Evidence Generation, Teleflex, Ireland

Speaker Image
Salvinia Mletzko

Associate Director Project Management, RQM+, Germany

Speaker Image
Heike Möhlig-Zuttermeister

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

Speaker Image
Sarah Panten

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

Speaker Image
Paul Piscoi

European Commission, Belgium

Speaker Image
Helene Quie

Founder & CEO, Qmed Consulting, Denmark

Speaker Image
Prof. Frank Rademakers

UZ KU Leuven, Belgium

Speaker Image
Sally Sennitt

Medical Director, RQM+, Belgium

Speaker Image
Nebojsa Serafimovic

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

Speaker Image
Amie Smirthwaite

Senior Vice President, Intelligence and Innovation RQM+, UK

Speaker Image
Mette Sørensen

Internal Clinician, TÜV SÜD, Denmark

Speaker Image
Ashley Stratton-Powell

Expert Assessor at the MHRA, UK

Speaker Image
Oge Swaby

Principal Business Consultant at NEC Software Solutions, UK

Speaker Image
Ankeet Tanna

Consultant, Hardian Health, UK

Speaker Image
Cécile van der Heijden

Advocaat / Attorney at law, Axon Lawyers, Netherlands

Speaker Image
Efstathios Vassiliadis
CEO, Evnia
Speaker Image
Nicola Wall

CEO, Afortiori Development, USA

SIGN UP FOR OUR NEWSLETTER