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Digital Health : What is the Landscape Looking like for Medicines?

Track:
Medicines of the Future: What Will Innovation Need and Bring?

Day & Time:
April 18, 2:00PM - 3:15PM (Central Europe Standard Time)

Session Number:
S0302

Room Number:
Shanghai 1-2

Level:
Intermediate

Type:
Session

Title:
Digital Health : What is the Landscape Looking like for Medicines?

Chair(s):
Chris Walker, MSc
Vice President, European Head of Regulatory Affairs
Amgen Ltd, United Kingdom

Description:
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(s):
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

Presentation(s) & Speaker(s):
Digital Biomarkers – Case Study
Christian Gossens, PhD
Global Head, Early Development Workflows
F. Hoffmann-La Roche Ltd., Switzerland

Discussion of how to develop product information that is easily accessible, understandable & relevant for the target audience by using new technologies and applying Health Literacy principles. This includes new ways for patient engagement processes.
Gesine Bejeuhr, PharmD
Regulatory Affairs/Quality
vfa, Association of Research-Based Pharmaceutical Companies, Germany

The Regulator's View on the Need to Regulate and Challenges to Keep Pace with Technology Development
Marisa Papaluca-Amati, MD
Marisa Papaluca-Amati, Scientific Committees Regulatory Science Strategy, Europe
European Medicines Agency, European Union, United Kingdom

Panel Discussion
Ernst Hafen
Professor
Institute Molecular Systems Biology, ETH, Switzerland