Streamlining Digital Health Assessments: Enhancing Usability, Reducing Burden & Navigating Regulatory Pathways from Validation to Approval
Time: 8:00 am
day: Pre-Conference Day
Details:
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 carers and patients on effective use of digital biomarkers to encourage patient compliance and ensure at home recorded data is sufficiently precise to provide valuable insights on disease burden
- Establishing relevance of measures at specific stages of disease
- 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
*Morning break & refreshments will be served during this session at 9:20pm
