Track 3: Data and Data Standards
This track focuses on validation methods and tools, development of standards, and quality assurance for data collected throughout the drug development lifecycle. Emerging topics such as real-world data collection methods from wearables and other mobile apps, and effective use of clinical registries will be also be covered.
Sessions in Data and Data Standards
Sunday, June 14 | Short Courses
Monday, June 15
Tuesday, June 16
- ICH 30th Anniversary Series: The Role of Multidisciplinary Topics
- Clinical Electronic Structured Harmonized Protocol (CeSHarP): ICH M11 - Status Update
- FDA Data Standards Update
Wednesday, June 17
- Combining Multiple Real World Data Sources to Maximize Value
- Data Strategy and Privacy Compliance in the Age of Digital Health: GDPR, HIPAA, and CCPA Implications
- Deploying Machine Learning in Data Management
- Getting Real About Data Sharing for Drug Development and Drug Safety: What COVID-19 is Teaching us About the Possibilities and How to Move From Anomaly to Precedent
- Advancing Clinical Research Through Fast Healthcare Interoperability Resources: An Industry Perspective of Where We Are and Where to Go
- Applying the Concepts of Good Clinical Practice in Real World Evidence
- Data Related International Policy and Strategy: EVDAS, E2B (R3), GDPR
Who is This Track is Designed For?
Professionals involved in: Informatics (bio and medical), data standards and quality control (regulatory standards implementation), data quality, clinical data management, clinical trial design, clinical operations, eClinical (electronic health records), submissions and global submissions, health economics outcomes research, biostatistics, medical writing, real world evidence, epidemiology, post-market studies, regulatory affairs and operations, and statistics.