Gul Erdemli

Company: Novartis AG

Job title: Global Program Regulatory Director

Seminars:

Developing Digital Mobility Outcomes for the Assessment of Mobility Performance: Lessons learned from Health Authority Consultations 1:30 pm

Mobility disability, a limitation in real-world walking to carry out mobility-related activities of daily living (ADL), is one of the most well-recognized characteristics in chronic diseases such as Multiple Sclerosis and Parkinson’s Disease The Mobilise-D consortium aims to demonstrate that Digital Mobility Outcome (DMO) measurements of mobility performance in the real-life setting are sensitive and…Read more

day: Day One

Workshop A: Navigating Regulatory Pathways for Digital Biomarkers: From Validation to Approval 9:00 am

With rapid advancements in the sensitivity of digital health technologies, now it is more crucial then ever to understand the regulatory requirements for biomarker qualification. By agreeing clinically relevant measures to the patient’s disease and understanding the technologies and parameters available, we can relate this back to CNS dysfunction to present the best evidence case…Read more

day: Pre-Conference Day Track A AM