Ebook

A Practical Approach and Lessons Learned from Aligning Regulatory Master and Reference Data with SPOR

A Practical Approach and Lessons Learned from Aligning Regulatory Master and Reference Data with SPOR

Pages 6 Pages

The SPOR system, developed by the European Medicines Agency (EMA), standardizes medicinal product data to improve interoperability and regulatory decision-making. It includes four master data domains: substances, products, organizations, and referentials. Successful alignment requires mapping internal data to SPOR, data governance, and continuous synchronization. SPORIFY, a tool automating this process, offers automatic synchronization, mapping, and governance support. Implementation is iterative and fosters improved data quality. As IDMP standards evolve globally, early alignment positions companies for compliance beyond Europe, benefiting global biopharma organizations.

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