Let’s Talk Labeling: From 0 to Critical Mass in 18 Months: How to Prepare for FHIR ePI

Pharma Global Labeling teams are facing two converging pressures:

1. Pace of Change: Numerous regulators are planning to implement FHIR ePI at a pace that industry is not used to. For example, EMA's draft ePI roadmap, published in March 2026, begins with a voluntary period late 2026; mandatory MAA in 2028; mandatory for all products by 2031. Jordan FDA mandated FHIR ePI from 2026. Japan, Maylasia, Taiwan, Indonesia, and South Korea are also looking into FHIR ePI.
2. Operational Efficiency: Workload volume and effort is outpacing constrained budgets/resources. There is mounting pressure to close the productivity gap with digital solutions, particularly with automation and AI. There is also a need to balance the business benefit of these new capabilities without compromising quality and compliance.

These pressures cannot be eased or solved with the legacy document-centric labeling workflow. To definitively ease or resolve these pressures and realize the benefits, we need to modernize the labeling workflow using structured, component-based content, extensive metadata, advanced version control, and audit trails.

What You’ll Learn

This session reframes ePI, automation, and AI as a single end-to-end labeling and artwork challenge. Attendees will explore:

• Why the monolithic XML approach struggles to yield benefits vs FHIR ePI's component-based XML approach
• How labeling must evolve from document-centric to component-based, metadata-centric content
• How a structured, component-based approach can be used to facilitate automation and increase the accuracy of AI output
• How to go from 0 to critical mass within 18 months

Participants will leave with a framework for evaluating their labeling workflow against a modernized ePI workflow.

Speakers

• Craig Anderson - Business Product Director (Labeling), Johnson & Johnson
• Murali Menon - CRO, Head of Sales & Services,  Docuvera Software