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Authors:
Sanja Grčić Plečko
Maja Fatiga
Dubravka Sudić
Keywords: health informatics; ISO IDMP; SPOR; Substances Management Services; Products Management Services; Organisations Management Services; Referentials Management Services; UNICOM; EMA
Abstract:
The authors describe challenges and learnings in the process of refactoring internal system for tracking the records of marketing authorization procedures and medicinal product database in the Agency for Medicinal Products and Medical Devices (HALMED) in order to comply with ISO IDMP (International Organization for Standardization, Identification of Medicinal Products) standards. HALMED’s plans include the medicinal products data model reconstruction, user interface adaptation, changes on the synchronization processes and establishing connection with SPOR (Substances, Products, Organisation and Referentials) data management services. In a response to the introduction of the ISO IDMP set of standards, the EMA (European Medicines Agency) initiated the SPOR data management service project, with the objective to provide the framework for standardization and structured data in medicinal products description.
Pages: 38 to 48
Copyright: Copyright (c) IARIA, 2022
Publication date: June 26, 2022
Published in: conference
ISSN: 2308-4359
ISBN: 978-1-61208-984-3
Location: Porto, Portugal
Dates: from June 26, 2022 to June 30, 2022