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Regulatory Submissions, Information, and Document Management Forum
Session 8 Track 1: IDMP Ontology: Semantic Interoperability Throughout the Entire Medicinal Product Lifecycle
- Director Regulatory Information Management
- Qdossier - A Celegence Company, Netherlands
This session will introduce the IDMP Ontology initiative of Bayer, Boehringer Ingelheim, GSK, J&J, Merck KGaA, Novartis and Roche, coming together at Pistoia Alliance Pistoia Alliance’s IDMP Ontology project. It will provide an outline of the implementation challenges of ISO IDMP standards at pharma companies and showcase how an ontology can help achieve semantic interoperability of product data. The IDMP Ontology augments the existing conceptual models defined in ISO IDMP standards, provides concise formal definitions and enables deep, semantic interoperability based on FAIR data principles.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand the value of the standardized ISO IDMP Logical Model applying FAIR data principles and semantic web technologies
- Apply presented implementation guidelines to increase IDMP adoption success
- Learn how to become a contributor that can shape further development of IDMP Ontology
Semantic Interoperability Throughout the Entire Medicinal Product Lifecycle with IDMP Ontology
Rafail Kasapis, MSc
- Seior Data Governance and Strategy Consultant
- OSTHUS, Germany
A Data-Centric Implementation of IDMP in Regulatory and Connected Functions with the IDMP Ontology
Heiner Oberkampf, PhD
- CEO and Co-Founder
- ACCURIDS, Germany
Broader Industry Initiatives and Benefits of IDMP for Pharma Companies
Sheila Elz, MA, MSc
- Master Data Manager
- Bayer, Germany