Registration

08.30 – 09.00

Welcome and introduction

Shayesteh Fürst-Ladani (MPP President, SFL)

David Haerry (Chair of the MPP2022 Program Committee, Brussels AIDS Treatment Group)

Karin Sartorius (Canton Basel-Stadt)

Combined products: regulation & patient engagement

Despite the development and increasing use of products combining medicinal products, medical devices and digital health technologies (combined products), there is no harmonized framework for these products and sectoral legislation apply to their different components. The session will provide various perspectives on outstanding challenges how to bridge the gap between the medicinal products and the medical devices frameworks. In the area of combined products, collaboration between the different stakeholders is key and, as such, the session will also address this topic by exploring patient engagement.

Chairs: Daniel Delfosse (Swiss Medtech) & Christiana Hofmann (TÜV SÜD)

Speakers
Stephan Affolter (Ypsomed)
Maria Dutarte (EUPATI)
Rahel von Rohr (anteris helvetia)
Atalah Haun (Veristat)

From research to clinical development

The development of combined products challenges organizations and requires new collaboration models within companies and between pharmaceutical companies, device manufacturers and tech companies. This session will focus on the clinical development of combined products and data generation and management.

Chairs: Marisa Papaluca (Imperial College London) & Ruth Foster (MSD)

Speakers
Laura Fregonese (EMA)
San Pun (AiMorphus)
Paolo Decuzzi (Italian Institute of Technology)
Claudia Dollins (BMS)

The panel discussion will gather representatives from the industry, regulators and notified bodies to exchange forward-looking perspectives on the framework for combined products.

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

Panelists
Mike Wallenstein (Novartis)
Bernhard Spörri / Sebastian Fuchs (Swissmedic)
Thinh Nguyen / John Weiner (FDA)
Sabina Hoekstra-van den Bosch (TÜV SÜD / Team-NB)

Digital health

The digitalization of healthcare is expected to bring significant benefits, both at the patient and at the healthcare system level. The session will dive into the challenges and opportunities for the development of digital technologies and their interactions with combined products, including a look at early use cases that are being explored with quantum computing.

Chairs: Eldin Smajic (Roche)

Speakers
Frederik Flöther (IBM)
Antoine Bourrier (Capgemini)
Iain Simpson (Phillips-Medisize)
Lada Leyens (Roche)