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
Lada Leyens, Takeda
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
