Simplifying the Management of Complex SPOR Data

This video provides an in-depth exploration of simplifying the management of complex SPOR (Substances, Products, Organizations, Referential) data, a critical component of the EMA's ISO IDMP (Identification of Medicinal Products) implementation. The webinar, presented by Remco Munnik from Asphalion and Gary Wilson from CorrIT, introduces "SPORIFY," an off-the-shelf software solution designed to automate the matching, synchronization, and integration of local company data with the EMA's SPOR master data. The core problem addressed is the significant challenge pharmaceutical and life sciences companies face in transitioning from xEVMPD to IDMP, which necessitates robust management of controlled vocabularies and organizational data provided by the EMA.

The presentation begins by setting the theoretical context of ISO IDMP and the role of SPOR as a master data system to achieve structured data for medicinal products. SPOR is broken down into its four domains, with a particular focus on Organizations (lists of marketing authorization holders, sponsors, manufacturers) and Referential (over 100 controlled vocabularies like dosage forms, routes of administration, countries). The speakers emphasize the benefits of master data, including improved analytics, more efficient regulatory decision-making, operational savings, better data quality, and alignment with future data standards, highlighting the current lack of standardization across departments and companies as a major hurdle.

Gary Wilson then provides a live demonstration of the SPORIFY tool, showcasing its user-friendly, non-technical interface. The demo illustrates how companies can upload their local data (e.g., units of measure, countries, pharmaceutical dose forms, organizations with addresses) using simple Excel templates. SPORIFY automatically matches this local data with EMA SPOR data, providing immediate feedback on compliance rates, suggested matches, and unmatched items. For organizations, the tool handles the complexity of matching both organization names and multiple associated locations simultaneously. The system also supports manual matching, allows users to define custom "resolution statuses" for data governance (e.g., "for review," "approved," "change request needed"), and provides export options (Excel or API) for integrating the mapped data back into internal systems.

A key feature demonstrated is SPORIFY's continuous synchronization capability, which automatically checks the EMA SPOR systems daily for updates. This ensures that any changes to controlled vocabularies or organization details are detected, and the system can automatically update matched records or notify users of changes to "favorited" organizations. The discussion also touches upon different master data integration models (registry, repository, hybrid) and how SPORIFY can support each, reducing manual effort and improving data accuracy. The overall process cycle for master data management—Identify, Match, Maintain, Govern, Integrate, and Synchronize—is presented, with SPORIFY significantly automating the synchronization and maintenance steps.

Key Takeaways:

• ISO IDMP and SPOR are Imminent: Despite perceived delays, the EMA's SPOR data is actively being utilized and is foundational for the upcoming ISO IDMP implementation, making proactive data management crucial for pharmaceutical companies.
• SPOR Data Domains: SPOR encompasses Substances, Products, Organizations, and Referential data. Organizations (MAHs, sponsors, manufacturers) and Referential (over 100 controlled vocabularies like dosage forms, countries) are currently live and require active management.
• Benefits of Master Data: Implementing master data management for SPOR leads to better analytics, more efficient regulatory actions, operational savings, improved data quality, and easier alignment with evolving data standards.
• Standardization is Key: Standardized product data is essential not only for regulatory activities (e-submissions, variations) but also for critical functions like e-prescription, serialization, tracking shortages, managing recalls, inspections, and pharmacovigilance.
• The Challenge of Dynamic Data: EMA's SPOR data, particularly for organizations, is constantly updated, changed, and added daily, posing a significant challenge for companies to manually track and maintain alignment with their internal systems.
• SPORIFY's Automated Matching: The tool automates the matching of local company data (from Excel or databases) with EMA SPOR data, providing immediate insights into data compliance and suggesting potential matches based on similarity.
• Comprehensive Mapping for Organizations: SPORIFY addresses the complexity of organization mapping by simultaneously matching organization names and associated locations, even when addresses are formatted differently in source systems.
• Customizable Data Governance: Users can define and apply custom "resolution statuses" (e.g., "for review," "approved," "change request") to unmatched or suggested items, enabling internal workflows and governance processes for data quality.
• Continuous Synchronization: SPORIFY automatically synchronizes with EMA SPOR systems twice daily, detecting changes and updating matched records or notifying users, thereby eliminating the manual burden of tracking updates.
• Flexible Integration Options: The system supports various master data integration models (registry, repository, hybrid) and offers data export via Excel or an Application Programming Interface (API) for seamless integration with internal systems.
• "Favorites" for Critical Monitoring: Users can "favorite" specific organizations or locations to receive special alerts for any changes, providing targeted monitoring for critical entities.
• Reduced Manual Effort: By automating matching and synchronization, SPORIFY significantly reduces the manual effort, potential for user errors, and time required to maintain compliance with EMA's evolving SPOR data.
• Future Roadmap: The solution plans to incorporate xEVMPD substance lists for preparation and will develop interfaces for the Substances (S) and Products (P) domains as they become available from the EMA.

Tools/Resources Mentioned:

• SPORIFY: A software solution developed by CorrIT for managing EMA SPOR data.
• Excel: Used for uploading local data into SPORIFY via templates and for exporting matched data.
• API (Application Programming Interface): Offered by SPORIFY for machine-to-machine integration with local systems.

Key Concepts:

• ISO IDMP (Identification of Medicinal Products): A set of five ISO standards for the unique identification of medicinal products globally, mandated by the EMA.
• SPOR (Substances, Products, Organizations, Referential): The EMA's master data system providing controlled vocabularies and master data for IDMP implementation.
  • Organizations (O): A list of all organizations (MAHs, sponsors, regulatory authorities, manufacturers) with unique IDs and locations.
  • Referential (R): A list of over 100 controlled vocabularies (e.g., dosage forms, routes of administration, countries, languages) used in regulatory submissions.
• xEVMPD (Extended EudraVigilance Medicinal Product Dictionary): The current system for medicinal product data submission to the EMA, which IDMP will supersede.
• Master Data: Non-transactional information (like SPOR data) considered key to core business operations and reused for multiple purposes, aiming for a "single source of truth."
• Resolution Statuses: User-defined categories within SPORIFY to manage the workflow and governance of matched or unmatched data (e.g., "approved," "for review," "change request").
• Registry System (Master Data Integration): Each local system maintains its own copy of data and looks up to a central hub (like SPORIFY) for the single source of truth.
• Repository System (Master Data Integration): Master data is moved out of local systems and maintained in a single central hub, which then feeds updates back into all connected systems.
• Hybrid Approach (Master Data Integration): A mix of registry and repository models, accommodating both older and newer systems within an organization.

Examples/Case Studies:

• Barcelona Benguela vs. Barcelona Spain: Used to illustrate the importance of master data for unique identification, preventing errors like booking a flight to the wrong city.
• "Capsule" vs. "Hard Capsule": Highlights the lack of standardization within different departments or companies, which SPOR aims to resolve by providing one unique term (e.g., "capsule, hard") with a unique ID and assigned synonyms.
• One A Pharma (Example Organization): Used in the demo to show how users can "favorite" an organization to receive special alerts for any changes to its data on SPOR.