Session-3-Setting-the-Scene-Digital-Health-and-Its-Impact

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Session 3: Setting the Scene: Digital Health Solutions and Their Impact on Drug Development and Access

Session Chair(s)

Solange Corriol-Rohou, DrMed, MD, PhD

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe

AstraZeneca , France

Digital Healthcare Solutions whether wearables, mobile apps, smart devices, home virtual assistants, predictive analytics, web health portals or blockchain-based electronic medical record systems are increasingly used to deliver personalised, efficient and informed care. However, with such innovation comes trust and responsibility in order to get the full benefits of digitally enabled healthcare services. The European Commission, which is working to provide its citizens access to safe and top quality digital services in health and care, recently released a Communication on Digital Transformation of Health and Care in the Digital Single Market, identifying actions to attain key priorities and build a healthier society. Such topic is also the focus of regulators since both EMA and FDA have started consultations and strengthening their expertise capabilities. But those technologies would need to be developed in conformity with data protection rules and other cybersecurity requirements.

Speakers representing the different organisations involved will provide their perspective via short presentations prior to joining a panel session where main challenges will be discussed.

Speaker(s)

European Commission Perspective

Katja Neubauer

European Commission, Belgium

Team Leader eHealth, Unit B3 - Cross Border Healthcare & eHealth, DG SANTE

EMA Perspective

Michael Berntgen, PhD

European Medicines Agency, Netherlands

Head of Scientific Evidence Generation

Industry Perspective

Thomas Metcalfe, MBA

F. Hoffmann-La Roche, Switzerland

Personalised Healthcare Ecosystems

Patient Perspective

Ines Hernando

EURORDIS, France

Patient Advocate

Sini Eskola, MPharm, MS, MSc

EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium

Director Regulatory Strategy

Academic Perspective

Cynthia Iglesias

Department of Health Sciences, University of York, United Kingdom

Senior Health Economist/Health Services Researcher

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