Creating a More Intelligent Pharmaceutical Industry: Enabling Regulatory Data Exchange – Webinar Series 4
Global Value Web, in collaboration with the Pistoia Alliance, hosted the fourth session of our ongoing webinar series dedicated to transforming regulatory data exchange in the pharmaceutical industry. This session brought together global experts from FDA GSRS, EMA, UMC, GSK, and industry partners to discuss the advancements and real-world implementation of IDMP (Identification of Medicinal Products) and the Global Substance Registration System (GSRS).
🔍 About This Webinar
This episode deep-dives into the progress of GSRS and its critical role in supporting IDMP standards adoption worldwide. The session highlights how standardized substance identification, UNII generation, and interoperable data exchange frameworks drive regulatory efficiency, enhance patient safety, and enable a truly connected pharmaceutical ecosystem.
🎯 Key Topics Covered
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Overview of GSRS and the Unique Ingredient Identifier (UNII)
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ISO IDMP framework and its importance in global regulatory alignment
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GSRS application modules: substance, application & product workflows
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Substance identification challenges and solutions
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Specified substances, synthetic schemes, and machine-readable data
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GSRS adoption projects at global agencies (BfArM, EMA)
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Data migration pipelines, mapping strategies, and system integration
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Ensuring interoperability across regulatory data ecosystems
The content is based directly on the webinar deck (Nov 2025) which includes detailed visual references, case scenarios, and structured workflows.
GVW_IDMP_Enabling Regulatory Da…
👤 Featured Speakers
Expert speakers from global regulatory and industry organizations, including:
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Dr. Marlene Kim – Project Manager, GSRS (FDA)
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Egor Puzanov – Systems Engineer, Bechtle GmbH
🌍 Why This Matters
As pharmaceutical products, ingredients, and clinical trials become increasingly global, regulatory authorities and biopharma companies need a harmonized approach to identifying, tracking, and exchanging medicinal product data.
GSRS and IDMP offer a unified, ISO-driven framework to:
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Improve data quality & consistency
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Reduce ambiguity in substance identification
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Strengthen pharmacovigilance and patient safety
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Enable faster regulatory submissions
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Connect product, substance, and clinical data seamlessly
This webinar helps organizations understand how to prepare for and implement these standards effectively across their systems.
