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Feb 08, 2024 10:00 AM - Feb 08, 2024 2:00 PM

Short Course: Mapping Common Regulatory Data Standards to FHIR

This is a Virtual Pre-Conference Short Course in conjunction with the Regulatory Submissions, Information, and Document Management Forum


Samuel  Thompson

Samuel Thompson

Managing Consultant, NNIT, United States

Sam has 20 years of cross functional, multi-disciplinary experience across Life Science, Healthcare, and Information Technology, focused on the applied use of data technology for clinical, regulatory and safety applications. His specific experience includes the design and implementation of lakes/warehouses, ETL scripting, and implementing regulatory compliant data management solutions. Special experiences/knowledge within: • Identification of Medicinal Products (IDMP) Readiness Assessment and Implementation • Clinical, Safety and RIM Vault implementations • Data Architecture with specific focus on Master data Management, Data Stewardship and Data Governance • SDTM, ADaM, PQ/CMC FHIR, IDMP (ISO) standards.

Kåre  Hyttel, MSc

Kåre Hyttel, MSc

Principal Consultant, NNIT, Denmark

I am specialized in various pharmaceutical data standards and FHIR. Enjoy data modelling and data mapping.

Vanni  Carapetian, MPH

Vanni Carapetian, MPH

Director, Regulatory Data, Genentech, A Member of the Roche Group, United States

Vanni brings nearly 20 years of life sciences and technology expertise drawn from team and leadership roles at Roche, J&J, and Amgen. Their experience spans clinical development, manufacturing, and regulatory and their principal interest lies in setting and executing strategies that enable organisations to generate value from data. In their current role, Vanni is the Regulatory Data Lead at Roche and is based in South San Francisco.

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