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Session 4: Regulators’ views on Digital Health
Session Chair(s)
Rebecca Stanbrook, RPh
Executive Director, Regulatory and Development Policy, Regulatory Affairs
Novartis Pharma AG, Switzerland
Speaker(s)
Qualification Advice Procedure: a Framework for Success
Francesca Cerreta, PharmD, MPharm, MS
European Medicines Agency, Netherlands
Principal Scientific Officer
National Experiences with Digital Health: What can we learn from our successes and mistakes?
Nikolai Constantin Brun, MD
Danish Medicines Agency, Denmark
Co-Chair, EMA-MHA Big Data Task Force; Dir, Div for Medical Eval & Biostatistics
What is Industry expecting from Regulators in Digital Health?
Kathleen Meely
AstraZeneca, United Kingdom
Director, Programme Lead GCP, R&D QA
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