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 Digital Biomarkers / SaMD / IVD / Medical Devices & Imaging 

Session 1 :

Drug Development & Digital Biomarkers in Clinical Trials

Conference Agenda

Date :

Time :

5 June 2024

8:00-19:00

Time

Title

Speakers

08:00-08:45

Registration and Welcome Coffee

.......

08:45-08:45

Opening Remarks from ECPM and co-Chairs

Annette Mollet, ECPM; Lada Leyens, Takeda; Dietmar Schaffarczyk, ETH

08:45-09:00

Key note: Introduction to Legal and Ethical Implications of AI in Healthtech

Thomas Szucs, ECPM

09:00-09:00

Introduction to Session 1

Lada Leyens, Takeda

09:00-09:15

AI in Drug Development

Aneta Tyszkiewicz, EFPIA

09:15-09:30

Systematically Including the Patients Experience in the Development of DHT-based Endpoints

Florian Lipsmeier, Roche

09:30-09:45

Using AI/ML to Analyze Data from Digital Endpoints

Jelena Curcic, Novartis

09:45-10:00

Another Leg of the Novel Digital Endpoint Nocturnal Scratch Journey to Acceptance; the DEEP and EMA Pilot

Carrie Northcott, Pfizer

10:00-10:15

The Future of Regulatory Acceptance of Digital Measures is Happening Now

Cathelijne de Gram, J&J

10:15-10:45

Panel and Q&A

Speakers + Cécile Tardy-Srinivasan, Day One

10:45-11:15

Networking Break

Session 2 :

Software as a Medical Device (SaMD)

11:15-11:15

Introduction to Session 2

Annette Mollet, ECPM

11:15-11:30

MDR - Article 5.5; A Faster Road for the Translation of Including AI in Innovative Medical Devices?

Philippe Cattin, USB

11:30-11:45

AI or Algorithm: How to Address Regulatory Hurdles

Stephan Küster-Gruber, Odilia Vision

11:45-12:00

Competent Authorities and AI: Standards and Evaluations in Health Applications

Dietmar Schaffarczyk, Dipl. Lead Auditor MedTech, QS Schaffhausen AG, QS International Ltd.

12:00-12:15

AI and Digital Health, a Policy Roadmap for Switzerland

Alessandro Blasimme, ETH

12:15-12:45

Panel and Q&A

Speakers + Cécile Tardy-Srinivasan, Day One

12:45-13:45

Networking Break / Lunch

Session 3 :

In Vitro Diagnostics (IVD)

13:45-13:45

Introduction to Session 3

Dietmar Schaffarczyk, ETH

13:45-14:00

To the Existing, the (Global) Evolving Regulatory Framework in Disruptive Technologies (AI) and the Opportunities for Switzerland in this Context

Eva von Mühlenen, Sidley Austin LLP

14:00-14:15

How to successfully build your Regulatory Strategy in the In-Vitro Diagnostics Landscape?

Pierre-Emmanuel Thiriet, EPFL / REA Diagnostics

14:15-14:30

Clinical Decision Support Software with AI for Personalized Medicine of Autoimmune Diseases

Enkelejda Miho, FHNW

14:30-14:45

IVDR- Implementation- Industry perspective

Claudia Popp, Roche

14:45-15:30

Panel and Q&A

Speakers + Cécile Tardy-Srinivasan, Day One

15:30-16:00

Networking Break

Session 4:

Medical Devices & Imaging

16:00-16:00

Introduction to Session 4

Dietmar Schaffarzcyk, ETH

16:00-16:15

Bridging Borders: Leveraging Paediatric Routine Patient Data for National and Global Healthcare Advancement

Linda Stamm, UKBB

16:15-16:30

Identifying Patients at Risk in Bone Fracture Care by Augmenting Digital Twins with AI

Andreas Arnegger, Osora

16:30-16:45

Reimbursement of Digital Therapeutics (DiGA) in Switzerland

Angelina Rau, Vischer

16:45-17:00

Machine Learning In Precision Oncology - When Data Science Meets Clinical Reality

Gabriele Gut, UZH

17:00-17:30

Panel and Q&A

Speakers + Giorgio Bergamini, Patient Representative

17:30-17:40

Closing Remarks

Thomas Szucs, ECPM

17:40-18:40

Networking Apéro Riche

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The Venue

Biozentrum, Basel, Switzerland

The conference will be held in the heart of Basel, at the Biozentrum. The venue offers state-of-the-art facilities and a perfect setting for networking and learning.

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