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Track 1: Data/Big Data/eHealth

DIA 2017: Driving Insights to Action! 

With 16 sessions specific to 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

Monday, June 19

Tuesday, June 20

Wednesday, June 21

Thursday, June 22


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