Welcome and introduction

Shayesteh Fürst-Ladani (MPP President, SFL)

Ruth Foster (Chair of MPP2023 Program Committee, MSD)

Lukas Engelberger (Government of Canton Basel-Stadt, Switzerland)

Keynote address

Speaker TBC

Opening statements followed by a moderated debate and Q&A

The panel discussion will gather representatives from the industry, regulatory authorities and a patient organization to discuss the regulation of combined products on a global level.

Moderation: Shayesteh Fürst-Ladani (MPP President, SFL)

Panelists
David Haerry (EATG)
John Weiner (US FDA)
Michael Berntgen (EMA)
MTE (invited)
MHRA (invited)
Swissmedic (invited)
European Commission (invited)

Digital health policy: current status and outlook

Short presentations followed by a Q&A

This session will revolve around digital health policy. Featuring speakers from the industry, authorities, the session will explore defining policy developments in digital health and provide an outlook on expectations and challenges in this area.

Chairs: Ruth Foster (MSD) & Nathalie Schober-Ladani (SFL)

Speakers
Petra Leroy Cadova (DG RTD)
Samuel Gavillet (SFL)
US FDA (invited)
EMA (invited)
European Commission (invited)

Regulatory assessment of combined products: experience in dialogue between stakeholders

Short presentations followed by a Q&A

In this session, representatives from notified bodies and the industry will exchange perspectives on the interactions between the different stakeholders for the assessment of combined products and potential solutions to improve the communication and facilitate access to innovative technologies.

Chairs: Mike Wallenstein (Novartis) & Christiana Hofmann (Anteris by Kymanox)

Speakers
Ilona Reischl (AGES)
Team-NB (invited)
Patients (invited)

Companion diagnostics as enablers of innovative treatment

Short presentations followed by a Q&A

The goal of this session is to present opportunities and challenges in the clinical development and regulation of companion diagnostics. The session will explore the different perspectives on clinical development and regulation of companion diagnostics through the lenses of academia, industry and regulators.

Chairs: Florian Wildenhahn (Roche) & Marisa Papaluca (Imperial College London)

Speakers
Prof. Antoni Bayes-Genis (Institut del Cor)
Falk Ehmann (EMA)
Novartis (invited)
EU IVD Expert Panel (invited)