Track 1: Data/Big Data/eHealth

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.

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