Leveraging ISO IDMP for Smarter Regulatory Processes in the EU

The pharmaceutical industry stands at a critical juncture as the European Medicines Agency (EMA) advances its implementation of ISO Identification of Medicinal Products (IDMP) standards through the SPOR (Substance, Product, Organization, Referential) data management services.

This transition presents significant challenges for Marketing Authorization Holders (MAHs) who must adapt their internal systems and processes to align with the new centralized regulatory framework. Organizations face complex data mapping requirements, system integration hurdles and resource constraints while implementing these changes.

However, this transformation also offers unprecedented opportunities, including streamlined regulatory submissions, enhanced data consistency across markets, improved pharmacovigilance capabilities through better product identification and more efficient management of product lifecycle changes.

In this webinar, the featured speakers will discuss EMA’s vision to unify fragmented regulatory systems into an integrated, interoperable framework. They will highlight how the Product Management System (PMS) aims to transform how medicinal product information is exchanged between stakeholders to improve patient safety through better signal detection and more precise adverse event analysis.

Topics will include:

• An overview of the EMA’s centralization strategy for regulatory systems
• Technical and operational challenges in the transition to IDMP compliance
• The intricate relationship between PMS and other critical platforms, such as EudraVigilance, and how these connections enhance pharmacovigilance capabilities

Register for this webinar to learn how to navigate ISO IDMP standards through the SPOR data management services for improved compliance across the EU pharmaceutical landscape.

Speaker

Ljubica Nikolaš, Director, Regulatory Registration and Compliance, PrimeVigilance

Ljubica joined PrimeVigilance in 2018 and currently serves as Director within the Regulatory Affairs department, leading the Regulatory Registration and Compliance unit. She holds a Master’s degree in Applied Chemistry from the University of Zagreb. Ljubica began her regulatory career in regulatory intelligence and later specialized in the EudraVigilance system, with a strong focus on the Article 57 database. During her time at PrimeVigilance, she led the development of a proprietary automation tool for managing XEVMPD data.

Her current work includes overseeing ISO IDMP implementation strategies to ensure data consistency and regulatory compliance. Under her leadership, the team delivers end-to-end support for marketing authorization applications and efficiently manages the ongoing maintenance of product licenses, helping clients navigate complex regulatory landscapes with confidence.

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