The International Conference on

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

Member of

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

REGISTER TODAY WITH YOUR TEAM

MEET OUR
SPEAKERS

Stuart Angell

Managing Director, IVDeology, UK

Edward Ball

Manager, Intelligence and Strategic Execution at RQM+, UK

Anna Bertilsson

Senior Director, Integra Life Sciences, Sweden

Michael Branagan-Harris

Founder & CEO, Device Access, UK

Josh Bridgens

European Medical Director for J&J Medtech, UK

Bethany Chung

Senior Manager, Technical, RQM+, USA

Sara Contu

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

Danielle Giroud

CEO, MD-Clinicals, Switzerland

Ella Helgeman

Director, Regulatory Affairs and Quality Assurance, Rehaler, Denmark

Richard Holborow

Global Head Clinical Compliance, BSI, UK

Breda Kearney

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

John Kilmartin

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

Ewa Lindqvist

Director, THREAD Research

Mattias Kyhlstedt

CEO and Founder, Synergus RWE, Sweden

John McDonald

Senior Director Clinical Evidence Generation, Teleflex, Ireland

Salvinia Mletzko

Associate Director Project Management, RQM+, Germany

Heike Möhlig-Zuttermeister

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

Sarah Panten

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

Paul Piscoi

European Commission, Belgium

Helene Quie

Founder & CEO, Qmed Consulting, Denmark

Prof. Frank Rademakers

UZ KU Leuven, Belgium

Sally Sennitt

Medical Director, RQM+, Belgium

Nebojsa Serafimovic

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

Amie Smirthwaite

Senior Vice President, Intelligence and Innovation RQM+, UK

Mette Sørensen

Internal Clinician, TÜV SÜD, Denmark

Ashley Stratton-Powell

Expert Assessor at the MHRA, UK

Oge Swaby

Principal Business Consultant at NEC Software Solutions, UK

Ankeet Tanna

Consultant, Hardian Health, UK

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

Regulatory Compliance Lead, Evnia, Denmark

Cécile van der Heijden

Advocaat / Attorney at law, Axon Lawyers, Netherlands

Efstathios Vassiliadis

CEO, Evnia, Denmark

The International Conference on

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

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The International Conference on

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

Member of

CONFERENCE VENUE

WHO SHOULD ATTEND

SUPPORT & EXHIBITION

PROGRAM

Dear Colleagues,​

REGISTER TODAY WITH YOUR TEAM

MEET OUR SPEAKERS

SIGN UP FOR OUR NEWSLETTER

SUPPORT &
EXHIBITION

Dear Colleagues,

MEET OUR
SPEAKERS