The 3rd Conference on

clinical studies with Medical Devices and IVDs

"The Data Journey - what sets successful
clinical studies apart from failures?"

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Dear Colleagues,

It is our great pleasure to welcome you to The 3rd Conference on Clinical Studies with Medical Devices and IVDs (CSMD2024) which will take place 29-30 May 2024 at the Hilton London Canary Wharf, in London, UK.

The conference will focus on how to set up clinical and performance studies with medical devices and IVD. In addition, delegates will learn how to implement the regulation and guidelines within this field and how to appropriately collect the data needed to support the clinical and performance evaluation pathways.

The programme will cover topics from all fields of early stage strategic consideration, practical examples from speakers that are working on implementing the strategy, compliance issues, and key areas such as:
– Clinical document build up for various types of studies
– Working with sites (contracting, compliance etc.)
– EDC and data management processes and documentation
– Monitoring
– Risk assessment and other related collateral topics

We look forward to welcoming you in London at The 3rd Conference on Clinical Studies with Medical Devices and IVDs (CSMD2024).

Sincerely,

HELENE QUIE

Conference Chair

MEET OUR
SPEAKERS

Marika Chrápavá

Medical Advisor & Regulatory Affairs Manager, Institute of Biostatistics and Analyses (spin-off of Masaryk University), Czech Republic

Eva Dahlberg

Clinical Manager, Qmed Consulting, Sweden

Carlos Galamba

Founder & Consultant - Head of IVD, MDx CRO, Spain

Esther Gerteis

VP Medical & Regulatory Affairs, TRICares, Switzerland

Danielle Giroud

CEO, MD-Clinicals, Switzerland

Ciska Janssens-Böcker

Director of Clinical Marketing, ValueConnected, Netherlands

Anette Kristiansen

Senior Clinical & Scientific Affairs Director, CRNA Neurescue Aps, Denmark

Sumit Mehta

CEO, CETAS Healthcare, UK

Tom Melvin

Associate Professor of Medical Device Regulatory Affairs Director, MSc Medical Device Regulatory Affairs, Ireland

Naeem Noordin

CEO, Siara Limited, UK

Maria Nyåkern, Ph.D.

Founder and CEO, ACR Consulting, Spain

Helene Quie

Founder & CEO, Qmed Consulting, Denmark

Benjamin Rieck

CEO of AngioConsult, Germany

Hindrik Robbe

Independent Consultant, Medical and Clinical Affairs, Netherlands

Sally Sennitt

Medical Director, RQM+,Belgium

Amie Smirthwaite

Senior Vice President, Intelligence and Innovation RQM+, UK

Professor Brian D. Smith

Principal, Pragmedic, UK

Robin Stephens

CEO, Psephos Biomedica, UK

Cécile van der Heijden

Advocaat / Attorney at law, Axon Lawyers, Netherlands

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The 3rd Conference on

CLINICAL STUDIES WITH MEDICAL DEVICES AND IVDS

28-30 May, 2024