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REGISTRATION FROM 1:30 P.M. |
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WELCOME
Eva von Mühlenen, Senior Advisor, Sidley, Geneva
Daniel Delfosse, Vice Director, Head of Regulation and Innovation, Swiss Medtech
Bernhard Bichsel, Co-CEO, Integrated Scientific Services (ISS) |
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PART I: Regulatory Priorities
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2:10 p.m. – 2:40 p.m.
Host: Eva von Mühlenen, Senior Advisor, Sidley |
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SWITZERLAND’S REGULATORY PATHWAY: BETWEEN EU REALIGNMENT AND GLOBAL CONVERGENCE
Glenda Marsh, Regional VP, Regulatory Affairs, EMEA and CAN, J&J MedTech
Daniel Delfosse, Vice Director, Head of Regulation and Innovation, Swiss Medtech |
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2:40 p.m. – 3:10 p.m.
Host: Eva von Mühlenen, Senior Advisor, Sidley |
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MAKING MDR AND IVDR WORK – LESSONS FROM THE COMBINE PROGRAMME AND PATHS TO SIMPLIFICATION, FLEXIBILITY, AND RELIANCE
Francesca Cipolli, Director Global Regulatory Affairs Precision Medicine and Digital Health, GSK
Ioana Ratescu, R&D Legal Head Safety, Development Europe and International Regulatory Affairs Legal Lead, Novartis |
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PART II: Global Trade and Politics
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3:10 p.m. – 3:40 p.m.
Host: Bernhard Bichsel, Co-CEO, Integrated Scientific Services (ISS) |
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U.S. POLITICAL SHIFTS AND TARIFFS: HOW TO REACT AS A SWISS MANUFACTURER
Bernard Bichsel, Co-CEO, Integrated Scientific Services (ISS)
Justine Fassion, Counsel, Sidley |
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4:10 p.m. – 4:50 p.m.
Host: Bernhard Bichsel, Co-CEO, Integrated Scientific Services (ISS) |
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NEW GLOBAL DYNAMICS – IMPACT ON MARKET ACCESS
Deborah Rossier, Head of Quality and Engineering, Integrated Scientific Services (ISS)
Marianne Kesseli, Senior Manager Regulatory Affairs, Oertli Instrumente AG |
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PART III: Corporate Responsibility |
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4:50 p.m. – 5:10 p.m.
Host: Sandra Item, Co-CEO, Integrated Scientific Services (ISS) |
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THE FUTURE OF EU SUSTAINABILITY – THE OMNIBUS PACKAGE
Michele Tagliaferri, Partner, Sidley
Anna Melin, Counsel, Sidley |
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PART IV: Artificial Intelligence in Medical Devices |
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5:10 p.m. – 5:50 p.m.
Host: Eva von Mühlenen, Senior Advisor, Sidley |
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SWITZERLAND’S EVOLVING AI REGULATION AND GLOBAL STANDARDS: COMPETITIVE EDGE OR CHALLENGE?
Effy Vayena, Associate Vice President for Digital Transformation and Governance and Professor of Bioethics at ETH Zurich
Christophe Perritaz, Head Non-Tariff Measures, Swiss Secretariat for Economic Affairs, SECO
Giorgio Rizzello, Head of Government Affairs Europe, Sonova
Karine Valterio, Senior Legal Counsel, Intuitive Surgical |
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WRAP UP / GOODBYE / WHEN DO WE MEET AGAIN?
Eva von Mühlenen, Senior Advisor, Sidley, Geneva
Daniel Delfosse, Vice Director, Head of Regulation and Innovation, Swiss Medtech
Bernhard Bichsel, Co-CEO, Integrated Scientific Services (ISS) |
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NETWORKING / DRINKS RECEPTION |
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