Track 3: Data and Data Standards
The overarching themes of this track are Navigating Data and Standards in a Big Data World, and Explosion of Technology and the Change to the Role of the Data Professional. With 14 sessions specific to Data and Data Standards, this track will appeal to a broad audience as it addresses the data topic from the perspectives of:
- Sources, standards, quality, handling, and regulatory requirements
- Current and emerging applications of data
The full spectrum of data and its uses to support biopharmaceutical development, approval, and postmarketing use will be covered in this track including: clinical (eClinical from electronic health records, wearables, and other mobile apps), and real-world data from large data sets (including registries).
Sessions in Data and Data Standards
Sunday, June 23 | Short Courses
- Data Visualization in the Life Sciences
View All Short Courses
Included Topic Areas in Data and Data Standards
DIA 2018’s Program and full list of sessions will be available in January. Meanwhile, see what topics and priorities we are designing content for.
- Challenges of real-world data in regulatory submission: sources, standards, uses, and quality
- FDA updates on regulations, standards strategy, and initiatives (PDUFA VI, CDMs, new Part 11), as well as evolving data standards from CDISC and other organizations
- Artificial intelligence and machine learning and their application in clinical trials
- Risk-based monitoring best practices for central monitoring and lessons learned from implementation, as well as the roles and responsibilities of various stakeholders
- The evolution of CDM in the light of digital data gathering – changing roles and responsibilities
- EHR data/eSource, wearable health – opportunities and challenges in integration with clinical trials
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, postmarket studies, regulatory affairs and operations, and statistics.