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 multiple 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 post-marketing 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
- CDER Direct: FDA's User Friendly Tool to Submit Registration and Listing Data
Monday, June 24
- Automation with Intelligence: Transformation from Human Resource to Artificial Intelligence in Risk Management
- Use of Real World Data in Clinical Trials: Abstracting Endpoints from Encounters
- Understanding the Data Journey in Virtual Trials
Tuesday, June 25
- Single Source of Truth, Integrations, or IoT (Internet of Things): Exploring Ways to Improve Connectedness of Clinical Data
- Creating Clarity: Changes at CDISC to Make Standards Implementation Easier for all Stakeholders
- FDA Data Standards Update
- The Machines are Here! Learn About Real Uses of Machine Learning and Artificial Intelligence in Pharma
Wednesday, June 26
- Methods for Integrating EHR Data into EDC and eSource Databases
- eSource Adoption: Where We Are - Our Experiences from eSource Implementation
- Identification of Medicinal Products: FDA's Perspective and Approach
- Real World Data Quality for Regulatory Decision-Making
Thursday, June 27
Take a look at and hear from our top 10 attended sessions from DIA 2018. Download the recordings here.
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.