Serialization: Italy, Europe & Global Outlook

In an ever-evolving regulatory landscape, serialization continues to play a central role in ensuring safety, traceability, and transparency in the pharmaceutical sector. More than five years after the introduction of the European Falsified Medicines Directive (FMD), the Italian market shows both progress and challenges: systems have been implemented and processes consolidated, yet operational gaps remain. The upcoming national regulatory updates, set to enter into force by February 9, 2027, bring new implications for pharmaceutical companies operating in Italy.

To address these issues, LifeBee — together with ProductLife Group Consulting & Digital, NMVO Italia, and international partner TraceLink — hosted a dedicated webinar that brought together industry experts and professionals from across Life Sciences. The session offered an in-depth look at the current state of serialization in Italy, the expected regulatory updates, and the broader global perspective on compliance.

The webinar shed light on the state of serialization and compliance from multiple angles, weaving together local and global perspectives. In Italy, the conversation focused on how companies are progressing in the adoption of serialization systems and the operational hurdles that still remain. Looking ahead, speakers examined the regulatory updates due by 2027, underlining the impact these changes could have on pharmaceutical players and their daily operations. The discussion then broadened to the international stage, with an overview of compliance requirements outside the EU, especially in rapidly growing markets. What clearly emerged is that serialized data is not just a tool for meeting regulatory obligations: when leveraged effectively, it can become a driver of strategic insights, innovation, and added business value.

The event featured interventions from:

• Elvis Graffeo, Head of Digital Operations, LifeBee and Director, PLG Consulting & Digital
• Alessandro Pelizzi, Associate Manager Serialization and Supply Chain BU, LifeBee
• Marcello Matarrelli, General Manager, NMVO Italia
• Allan Bowyer, Senior Director Community Engagement, TraceLink

Each speaker offered practical insights, ranging from operational lessons learned in Italy to the international dynamics shaping serialization and compliance worldwide.

This session provided a comprehensive update for professionals working in compliance, quality, operations, and digital transformation in Life Sciences. By combining regulatory updates with practical examples and global perspectives, the webinar highlighted how serialization can evolve from a regulatory obligation into an opportunity for efficiency and innovation.

The webinar recording remains available for all registered participants.

🗓 Date: 2 October 2025 
🕒 Time: 11:00 AM CET 
📍 Format: Online | Free registration