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Efficient Data Exchange: Drivers for End-to-End Standards Adoption
Session Chair(s)
David Sidney Ross, MBA, MSc, PMP, RAC
Senior Director, Regulatory Data and Submissions
AstraZeneca, United States
Internal solutions for translation between regulatory frameworks to assure right use of control vocabularies to exchange data as structured components of submissions to Health Authorities, CMOs, CROs.
Learning Objective : Analyze how regulatory digital data from divergent sources must meet varying ICH and Regulatory Authority standards; Identify gaps in applying external regulatory standards to internal industry data; Examine specific examples of gaps, such as enhanced granularity and differing regulatory frameworks (e.g., IDMP, XEVMPD, GSRS).
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