Let’s Talk Labeling: Structured Content Authoring – Infrastructure for the Future of Digital Labeling

This presentation will articulate how implementation of a Structured Content Authoring (SCA) infrastructure for Labeling represents a foundational shift in regulatory labeling from document-centric processes toward data-centric, modular content management, positioning organizations to respond effectively to accelerating regulatory and technological change. Traditional labeling approaches, characterized by static documents, manual reuse, and limited traceability, introduce risk in global consistency and impede effective lifecycle management. As evidenced by global regulatory trend towards digital requirements for Labeling management, including EMA ePI initiatives, FDA PDUFA VII Digital Health Technologies, and other globally emerging FHIR-based standards, the need for scalable digital Labeling infrastructure has become critical opposed to optional. This session will emphasize that SCA is not simply a technology implementation, but rather an enhancement of core regulatory capability, enabling structured governance, metadata-driven control, and format-agnostic content reuse. The discussion will frame SCA as the enabling infrastructure that transforms labeling from a static deliverable into a dynamic, governed data asset capable of supporting both current operations and future innovation.

Additionally, we will also review immediate and tangible value realized through SCA implementation at Astellas Pharmaceuticals, including both operational and compliance improvements. Specifically, process simplification is a primary benefit, with cycle times reduced by 50% since the implementation of SCA, and while other factors contributed, SCA is the primary contributing factor to the reduction. Inspection readiness is strengthened through enhanced traceability, global/local alignment, and standardized management of deviations from the CCDS, with sustained compliance performance supporting the robustness of the model. Additional value is realized through internal operations initiatives, which will be explained in detail.

Finally, the session will position SCA as a critical enabler of future-state capabilities, particularly in the context of advancing artificial intelligence applications in regulatory labeling. While fully autonomous AI-driven labeling authoring remains an emerging capability, the effectiveness of such technologies will be fundamentally dependent on the availability of structured, well-governed content enriched with metadata. The presentation will explore how SCA establishes this prerequisite data architecture by decoupling content from document format, enabling granular content reuse, and ensuring consistency, findability, and traceability across the enterprise.

What You’ll Learn

• How global regulatory trends are rewarding companies that invest in digital Labeling infrastructure
• How the implementation of SCA has yielded both short and mid-term value at Astellas Pharmaceuticals and how that success can be reproduced
• How the implementation of digital Labeling infrastructure, and particularly SCA, will set your Labeling team up for success in the future

Who Should Attend

• Regulatory Labeling professionals
• Regulatory operations professionals
• Personnel interested in learning more about Labeling and supporting systems

Speakers

• Tara Skuse - Client Solutions Partner at NPG
• Eric Randel - CCDS & Labeling Lead at Astellas Pharma