As the EU moves toward full serialization compliance, this session will focus on the critical shift from meeting regulatory requirements to optimizing serialization processes. Attendees will gain insights into the latest updates in European serialization efforts, why aggregation is only a question of time, upcoming challenges like batch-related coding for primary packaging and recent developments. Additionally, the session will discuss the refinement of alert management systems at both the national and manufacturer levels, ensuring streamlined and efficient operations across the board. In this session, you will learn about:

• Latest developments in EU serialization efforts and their operational impact.
• Alert management systems are being optimized at both the national and manufacturer levels for improved efficiency.
• What is going on outside EU and what influence it could have.
• Shifting from a compliance-driven approach to proactive process optimization in serialization.

Pharmaceutical track and trace systems have rapidly evolved beyond regulatory compliance tools to become strategic enablers of operational efficiency, supply chain transparency, and product integrity. With increasing complexity in serialization requirements, data integration, and emerging tech applications—from blockchain to AI—the technical demands on serialization infrastructure continue to grow. This panel brings together experts to explore the latest advancements and unresolved technical hurdles in the deployment. Panelists will exchange lessons learned from global rollouts, discuss data architecture evolution, and assess how TrackTS is intersecting with broader digitalization agendas in manufacturing and distribution. The following will be discussed:

• How are companies successfully integrating TrackTS with MES, ERP, and warehouse systems to enable seamless serialization workflows?
• What are the latest approaches for managing and validating vast serialization data across global operations and partners?
• Where are technologies like blockchain and AI proving their worth in serialization, and what are the limits of their current applications?
• As Trackts shifts toward cloud-based models, how are organizations adapting their cybersecurity strategies to ensure system integrity?

• How can global companies align their serialization efforts to ensure compliance while optimizing processes?
• What challenges are pharmaceutical companies facing in meeting regional serialization requirements, and how can they overcome them?
• How to deal with requirements not covered by standards?
• What influence to expect from “QR-code countries”?
• What opportunities can be taken from serialization to make better use of the investment?

In the Harvesting Session the workshop moderators of the event will summarize the results of their discussions and highlight key findings from the World Cafés.