Raffaella Fallone

Clinical Data Management & Clinical Supply Lead Angelini Pharma

Conference Day One: Tuesday 12 May 2026

2:00 PM CASE STUDY: A UNIFIED DIGITAL SYSTEM FOR IMP LABELLING AND PACKAGING DESIGN

Managing investigational medicinal product labelling and packaging for clinical trials is one of the most complex and regulated processes in the supply chain. To streamline this the team at Angelini Pharma created a custom digital platform that centralises label definition, packaging method design, and cross-functional approvals within a single environment. This in-house solution was built after recognising a significant market gap: no existing system could integrate label management, packaging design, and approval workflows while maintaining full compliance traceability. The platform enables transparent collaboration between Clinical Supply, QA, Clinical Development, QP and Clinical Trial Manufacturing, with role-based access for review and sign-off.

Key Features and Innovations:

End-to-End Traceability: Tracks the entire label lifecycle, from initial design to final packaging approval.
Cross-Functional Access: Clinical Supply, QA, Clinical Development, QP and Clinical Trial Manufacturing teams collaborate in real time within the same system.
Regulatory Readiness: Facilitates the preparation and approval of IMP labels for submission to the competent authorities.

Check out the incredible speaker line-up to see who will be joining Raffaella.

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