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Digital Health : What is the Landscape Looking like for Medicines?
Session Chair(s)
Chris Walker, MSC
VP, Head of Regulatory Affairs (EU,LATAM,MiddleEast,Africa,CAN), Amgen, United Kingdom
The advent of Digital is set to revolutionize healthcare establishing new technologies and data insights that deliver greater value to healthcare systems, enhancing clinical decision making and ultimately improving outcomes for patients.This session will provide an overview of the current state of play of policy and regulatory developments in Europe , that medicines developers and digital technology providers for the pharma sector should be aware of .
Learning Objective : Understand the most recent external developments in the area of Digital Health . Analyse the existing and upcoming initiatives from different stakeholders in Digital health and their relevance to business activities
Speaker(s)
Christian Gossens, PHD
Global Area Head, Digital Biomarker Informatics, F. Hoffmann-La Roche Ltd., Switzerland
Digital Biomarkers – Case Study
Gesine Bejeuhr, PHARMD
Pediatric Regulatory Leader, Bayer AG, Germany
New Technologies and New Approaches to Involve Patients to Improve Medicinal Product Information
Marisa Papaluca-Amati, MD
Marisa Papaluca-Amati, Scientific Committees Regulatory Science Strategy, Europe, European Medicines Agency, Netherlands
The Regulator's View on the Need to Regulate and Challenges to Keep Pace with Technology Development
Ernst Hafen
Professor, Institute Molecular Systems Biology, ETH, Switzerland
Panel Discussion
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