Leveraging ISO IDMP for Smarter Regulatory Processes in the EU

As the European Medicines Agency (EMA) advances its implementation of ISO Identification of Medicinal Products (IDMP) through the SPOR (Substance, Product, Organization, Referential) data management services, pharmaceutical companies face both significant challenges and valuable opportunities.

For Marketing Authorization Holders (MAHs), adapting to this centralized regulatory framework means addressing complex data mapping, system integration, and operational change. However, organizations that successfully navigate this transition can benefit from more efficient regulatory submissions, improved data quality, and enhanced pharmacovigilance capabilities.

This webinar offers practical guidance on how to approach ISO IDMP implementation to drive smarter, more compliant regulatory processes in the EU. It highlights how the EMA’s Product Management Service (PMS) connects with other key platforms like EudraVigilance to improve safety monitoring and operational efficiency.

Led by Ljubica Nikolaš, Director of Regulatory Registration and Compliance at PrimeVigilance, this session provides actionable insights to help organizations navigate this evolving regulatory landscape with confidence.

Key Takeaways Include:

• How EMA’s centralization strategy is transforming regulatory processes across the EU
• Key technical and operational challenges in implementing ISO IDMP standards—and how to address them
• How PMS integrates with EudraVigilance and other platforms to strengthen pharmacovigilance and improve data consistency
• Strategies to future-proof regulatory operations and maintain compliance amid evolving requirements
• Real-world insights into managing ISO IDMP implementation for improved efficiency and patient safety outcomes