WEBINAR: Leveraging ISO IDMP 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, Ljubica Nikolaš 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.

 

Join our Expert Speaker

Ljubica Nikolaš

Director, Regulatory Registration and Compliance

 

The key topics of discussion 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.