Annual Conference
8 September 2022 – Agenda
The conference program (8 September 2022)
Welcome and introduction
09.00 – 09.30
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)
Session 1
09.30 – 10.30
Regulatory framework for combined products
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 for manufacturers and how to bridge the gap between the medicinal products and the medical devices frameworks.
Chairs: Daniel Delfosse (Swiss Medtech) & Christiana Hofmann (TÜV SÜD)
Speakers
Stephan Affolter (Ypsomed)
Maria Dutarte (EUPATI)
Rahel von Rohr (anteris helvetia)
Invited
Break
10.30 – 11.00
Session 2
11.00 – 12.00
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)
Lunch Break
12.00 – 13.00
Panel discussion
13.00 – 15.00
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 (TÜV SÜD / Team-NB)
Regulatory authorities (invited)
Keynote address
15.00 – 15.30
Keynote
Invited
Break
15.30 – 16.00
Session 3
16.00 – 17.00
Digital health
The digitalization of healthcare is expected to bring significant benefits, both at the patient and at the healthcare system levels. The session will dive into the challenges and opportunities for the development of digital technologies and their interactions with combined products.
Chairs: Eldin Smajic (Roche)
Speakers
Frederick Flöther (IBM)
Antoine Bourrier (Capgemini)
Iain Simpson (Phillips-Medisize)
Lada Leyens (Roche)
Wrap-up and closing
17.00 – 17.15
Wrap-up and closing
Shayesteh Fürst-Ladani (MPP President, SFL)
David Haerry (Chair of the MPP2022 Program Committee, Brussels AIDS Treatment Group)
Questions regarding the event organization
Questions regarding the conference program
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