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Track 1: Data/Big Data/eHealth
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With 16 sessions specific to data/big data and eHealth, 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 (e-clinical from electronic health records, wearables, and other mobile apps), and real-world data from large data sets (including registries).
Highlights in Data/Big Data/eHealth
- Impact of PDUFA VI on data requirements and standards
- FDA’s new study data standards requirements and new data submission requirements
- Data standards such as CDISC, CDISC-SEND, CDASH 2.0, ADaM, HL7 updates, and IDMP
- Emerging programs such access to Sentinel data through IMEDS
- Mobile health – latest on use of mobile health technology in clinical trials and participatory research
- Risk-Based Monitoring (RBM) – beyond methodology to implementation challenges, lessons learned, impact on roles, identifying data trends, and potential issues
- Novel uses of big data in early development
- Leveraging big and real world data in clinical trials
- Featured Topics in Risk Based Monitoring, Data Management, Clinical Operations, Quality, and Career Development
DIA recommends this track and associated sessions to professionals involved in: Informatics (bio and medical), biostatistics, data standards (and regulatory standards implementation specialists), data quality, clinical data management, clinical trial design, clinical operations, e-clinical (electronic health records), submissions and global submissions, health economics outcomes research, postmarket studies, and regulatory affairs and operations.
Sessions in Data/Big Data/eHealth
Sunday, June 18 | Short Courses
- Digital Health Technologies for Combination Products and Beyond: Development and Regulation
- Smart, Innovative Risk-Based Auditing: Shifting the Paradigm
- Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
Monday, June 19
- Big Data: Combining Registries and Legacy Clinical Trial Databases
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Tuesday, June 20
- Big Data: Regulatory Information
- Mobile Health: Participatory Research
- FDA Session: Health IT at FDA
- Evolving Data Standards and Regulations
- FDA Session: Electronic Submissions and Data
- Big Data: Genomics and Personalized Medicine
- Big Data: Current and Emerging Technologies
- Data Quality
- Data and Privacy Protection
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Wednesday, June 21
- Quantified Self Tracking
- Big Data: Management and Analytics
- EHRs/eSource and Emerging Data Streams
- Leveraging Big Data/ Real-World Data in Enabling Efficient and Data-Driven Clinical Research From Sponsor, Vendor, and National Health System Perspective: Case Studies
- Risk-Based Monitoring: Convergence of Technology, Processes, and People
- Risk-Based Monitoring: Convergence of Technology, Processes, and People: Panel Discussion
Thursday, June 22