ACCURIDS, Boehringer Ingelheim, and MAIN5 Win TOPRA Award for EMA PMS Compliance Solution

We are incredibly proud to announce that ACCURIDS, together with our partners Boehringer Ingelheim and MAIN5, has been honored with the prestigious TOPRA Award for Regulatory Excellence in the "Innovation" category.

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The TOPRA Awards recognize outstanding achievements in the deployment of innovative ideas and cutting-edge technologies. Winning this award is a testament to our shared vision: transforming how the pharmaceutical industry manages complex regulatory data through the power of Knowledge Graphs and the IDMP Ontology.

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The Challenge: Data Quality Across Sources

In the rapidly evolving regulatory landscape, ensuring high data quality and determining the "truth" for regulatory processes is a massive challenge. Pharmaceutical companies often struggle with siloed systems—ranging from internal RIM and SAP systems to external Regulatory Agency platforms like the EMA’s SPOR services.

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The specific challenge we tackled was the alignment of Boehringer Ingelheim’s internal product data with the European Medicines Agency’s Product Management Service (EMA PMS). With data coming from various sources with different quality and granularity, manual comparison is often resource-intensive and prone to error.

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The Winning Solution: A Scalable, Automated Approach

To solve this, the team deployed the IDMP Data Standardization Fabric. By utilizing Knowledge Graph technology and the IDMP Ontology (IDMP-O), we created a solution that enables interoperability between internal systems and the EMA.

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Our award-winning approach involves:

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1. Automated Transformation: First, the solution handles the heavy lifting by automatically transforming complex EMA PMS FHIR messages into a readable, standardized format. This establishes a clean, understandable baseline for comparison without manual data wrangling.
2. AI-Driven Auto-Matching: Once the data is prepped, the platform runs an automated, side-by-side comparison of your internal data (from RIM, Veeva, MDM, etc.) against the validated EMA dataset. It utilizes rule-based logic and AI to auto-generate mapping proposals, allowing Subject Matter Experts to identify discrepancies efficiently without checking thousands of records line-by-line.
3. Streamlined Issue Resolution: We turn insights into action with a user-friendly workflow that enables data stewards to coordinate the resolution of discrepancies directly in a single interface. This system captures alignment assessments, tracks progress via a ticketing system, and ensures every change is fully traceable and audit-ready.

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Why We Won: Efficiency and Impact

The TOPRA Innovation Award honors ideas that drive efficiency and productivity. Our joint solution delivered exactly that:

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• Massive Efficiency Gains: The solution saves up to 75% of manual PMS data alignment effort by automating the comparison process.
• Data Quality: It ensures real-time, accurate, and standardized product data, which is critical for patient safety and regulatory compliance.
• Scalability: While the initial use case focused on EMA PMS, the architecture is future-proof. It is designed to be scalable to other jurisdictions and regulatory requirements beyond the EU.
• Standards-Based: The solution is built on the Pistoia Alliance IDMP Ontology, ensuring it aligns with global open-source standards.

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A Victory for Collaboration

This achievement would not have been possible without deep collaboration. It represents the perfect synergy between:

• Boehringer Ingelheim: Providing the strategic vision and complex real-world use case.
• MAIN5: Delivering expert consulting and implementation support.
• ACCURIDS: Providing the semantic technology and Knowledge Graph platform.

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We want to extend a heartfelt thank you to the key contributors who drove this project to success, including Fabian Muttach, Max Fink, and Joerg Stueben from Boehringer Ingelheim; Michiel Stam, Dominik Gigli, and Matthias Sijtstra from MAIN5; and our own Raphael Sergent and Heiner Oberkampf at ACCURIDS.

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Looking Ahead

As one of our colleagues noted, "This is just the beginning! ISO IDMP is the future of the Pharma Industry."

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The transition to data-centric regulatory affairs is no longer a concept—it is a reality. We are excited to continue pushing the boundaries of what is possible in Regulatory Affairs, moving from simple compliance to true data interoperability.

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Ready to start your own data adventure? Discover how ACCURIDS can streamline your EMA PMS compliance.

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