Join us for another IDMP Ontology webinar where we discuss important achievements of our IDMP-O project. These sessions are designed to improve data alignment and interoperability across the pharmaceutical industry.
Agenda
Introduction
Status and Progress of Phase 4 use cases
Batch Tracking
Regulatory Data Alignment: EMA PMS and other jurisdictions
Data inter-operability is a key enabler to accelerate life science workflows. Yet, many concrete hurdles exist. For example, organizations use different definitions for similar core concepts, requiring significant amounts of mappings across data sets even within a given company. The first objective of the Pharma General Ontology (PGO) project is to define a set of agreed-upon core entities, the PGO “core concepts”, and recommendations for associating controlled terminologies to service data exchange among Pharmaceutical Industry stakeholders. By reusing community-agreed terms and definitions, PGO aims to help organizations enhance data interoperability, integration, discovery, and reuse.
The webinar will address:
PGO vision
Deliverables Phase 1 & Next Steps
Q&A Session with the participants
Speakers
Philippe Rocca-Serra / Astrazeneca / Senior Director – FAIR Collaboration – Data Office
Martin Romacker / Roche / Product Manager Roche Data Marketplace (RDM)
Markus Hartmann / Merck Group / Global Product Lead Data Semantics
Birgit Meldal / Pfizer / Senior Manager, Enterprise Data Standards and Ontologies
Peter McQuilton / GSK / Senior Product Owner – Reference Data, Information & Data Architecture and Ontologies
Elena Businaro / Chiesi Group / R&D and PPM Digital Strategy and Execution Support Head
Joshua Daniel Valdez / Novo Nordisk / Head of Ontology and Semantic Engineering
Moderation: Giovanni Nisato / Pistoia Alliance / Project Manager PGO
The FAIR 2024 Business Survey Report presents key insights and recommendations on how pharmaceutical and life science companies are applying FAIR Data Principles across their organizations. Based on input from survey respondents and industry experts, the report highlights emerging business value, challenges, and the growing need for clear ROI frameworks to support FAIR’s strategic impact.
The Pistoia Alliance is building a pharmaceutical CMC process ontology based on the ISA88/95 framework.
Our aim is to standardize laboratory and plant production process recipes to establish standardized definitions, facilitate digital technology transfers and integration with execution systems to capture structured process data for material lot genealogy tracking, streamlined technology transfers, and advanced process analytics; thereby enhancing efficiency and transparency throughout the pharmaceutical production lifecycle.
Having shown value of a semantic approach to CMC process management during the initial PoC phase, we have now continued with the next phase of the work to move beyond the PoC to a usable Ontology.
For more information please visit our dedicated project page: CMC Ontology.
As life-science organizations race to adopt (generative) AI, one point begins to stand out: your AI is only as good as your data. While large language models (LLMs) offer powerful capabilities, they’re not tailored to specialized scientific data—and do need a solid data foundation. Making data Findable, Accessible, Interoperable, and Reusable (FAIR) enables AI systems to deliver more accurate, reliable, and cost-effective outcomes.
Key points include:
Why many AI projects are still fundamentally reliant on robust data management
How FAIR Data complements LLMs through explicit semantics and structure
The critical role of data quality and governance in AI success
Whether you’re a data steward, scientist, or innovation leader, this session will help you get more perspective aligning your data and AI strategies for maximum impact. Join us on May 21 to explore why durable AI strategy needs a robust data strategy including FAIR Principles. Don’t let unstructured data hold your AI back—make it FAIR.
Speakers
Angelika Fuchs, Roche, Chapter Lead, Data Products & Platforms
Martin Robbins, Ontoforce, Product Manager
Tom Plasterer, XponentL Data, Managing Director, Knowledge Graph & FAIR Data Capability
Beyond Research: Realizing the Value of FAIR Initiatives
The FAIR Community has undertaken an extensive survey to assess the impact of FAIR data in life science companies. Our new report examines the most significant business drivers for implementing FAIR data principles and the key outcomes being delivered.
Pharmaceutical companies are applying FAIR in research and extending it to development, clinical, and operational functions. FAIR initiatives that started five or more years ago now deliver tangible improvements in data management processes and enhanced operational efficiency. Thanks to all our members who contributed to this vital research.
Follow-up online Q&A session to the Pistoia Alliance/Cognizant in-person workshop on the Global Substance Registration System (GSRS) implementation at GSK.
The Pistoia Alliance has successfully completed a pilot on the digital transfer of analytical High-Performance Liquid Chromatography (HPLC) methods and results between chromatography data systems (CDS) via a central data storage system using a standardized machine-readable data format, which transforms methods from paper documents to digital instructions.
With the EMA’s Product Master Data Service live since 2024, ISO IDMP conformance is no longer looming at the horizon but an urgent regulatory imperative. Yet aligning complex medicinal product data to IDMP standards remains a major challenge for many Marketing Authorization Holders (MAHs).
Join experts from ACCURIDS and MAIN5 to discover a proven, data quality-driven method to assess and boost IDMP conformance using the IDMP Ontology. Learn how to automate maturity assessments, resolve common data issues, and rapidly build high-quality IDMP knowledge graphs. We’ll explore how AI supports intelligent data alignment across substances, products, and terminologies, and provide concrete examples of conformance measurement and remediation. This webinar is your practical guide to turning regulatory requirements into achievable data quality objectives — and ensuring your organization is ready for IDMP 2025 and beyond.
Agenda
Overview of latest IDMP timelines and actions for MAHs
Summary of pharma challenges in medicinal product data management
Why product data conformance with ISO IDMP is a MUST-Have?
Measure and increase IDMP data conformance with the IDMP Ontology and AI
The investment case for data standardization with the IDMP Ontology
