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

Time: 9:00 am
day: Pre-Conference Day Track A 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 to health authorities.

Workshop highlights include:

  • Exploring standardization and validation of clinical biomarker measures to qualify decentralized trial requirements • Demonstrating incremental benefit over established technologies for a more thoughtful step-wise approach to ensure health authorities recognize outcomes as important
  • Investigating interagency collaboration, data sharing and harmonization efforts to streamline regulatory processes and establish consensus on standardization parameters
  • Delving into key geographical differences in regulation between the DHT regulations at the FDA and the IVDR at the EMA
  • Considering data quality and compliance implications with data handling security standards, such as GDPR, surrounding wearable technology for quality of life tracking and geotracking in psychiatric disorders
  • Adapting more aggressive approaches in trial design to ensure sufficient data