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Session 5, Track 2: Igniting Seamless Data Flow: Enhancing Business Processes and Governance with FHIR and ICH Innovations
Session Chair(s)
Maria Sagoua, MHA
United States
This session will explore the transformative initiatives by the International Council for Harmonization (ICH) to enhance global regulatory collaboration through innovative information exchange standards. It will highlight ICH Expert Working Group initiatives focused on establishing electronic communication standards and evolving eCTD guidelines. The session will also discuss the optimistic impact of adopting HL7 Fast Healthcare Interoperability Resources (FHIR) for regulatory submissions, emphasizing improved data quality, governance, and operational efficiency in the pharmaceutical sector.
Is Your Data Flammable and Controlled? A Case for FHIR in Regulatory Affairs - Kåre Hyttel, NNIT Inc.
Enhancing Global Regulatory Collaboration through ICH's Information Exchange Innovations - Rodrigo Palacios, F. Hoffmann-La Roche
Learning Objective : At the conclusion of this session, participants should be able to:- Comprehend ICH initiatives' role in global regulatory collaboration and reliance
- Evaluate electronic submission standards' impact on regulatory efficiency
- Explore FHIR's implications for regulatory data and its use within pharmaceutical organizations
Speaker(s)
Is Your Data Flammable and Controlled? A Case for FHIR in Regulatory Affairs
Kåre Hyttel, MSc
NNIT, United States
Managing Consultant
Enhancing Global Regulatory Collaboration through ICH's Information Exchange Innovations
Rodrigo Palacios, MBA
F. Hoffmann-La Roche Ltd., Switzerland
Senior Director, Technical Regulatory Policy