Gul Erdemli

Company: Novartis

Job title: Global Program Regulatory Director

Seminars:

Streamlining Digital Health Assessments: Enhancing Usability, Reducing Burden & Navigating Regulatory Pathways from Validation to Approval 8:00 am

With rapid advancements in the sensitivity of digital health technologies, now is more crucial than ever to ensure device usability and reduced burden on patients, while navigating regulatory requirements for biomarker qualification. Workshop highlights include: Exploring standardization and validation of clinical biomarker measures to qualify decentralized trial requirements Strategizing on how we can best equip…Read more

day: Pre-Conference Day

Interactive Breakout Session: Considerations for Regulatory Acceptance of DHT-Derived Endpoints 3:00 pm

Splitting into breakout groups to solve scenario-based challenges, leveraging diverse cross-functional expertise of stakeholders in the room, presenting back and learning from the experience and approach of each working group. Discussion Questions include: What is the advantage of qualifying vs validating digital endpoint measures for individual drug development programs? What would be the best strategy…Read more

day: Day One

Developing Digital Mobility Outcomes for the Assessment of Mobility Performance: Lessons learned from Health Authority Consultations 1:00 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