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Session 7: eLabeling: Patient Interactions, Advanced e-Labeling Initiatives, and Public/Private Consortia Insights
Session Chair(s)
Theresa Brunone, MLS, MS
Head-Labelling Compliance and Implementation, Global Labeling, GlaxoSmithKline, United States
Kathleen Salazar, MA, MBA
Head, Global Labeling Operations, Johnson & Johnson Innovative Medicine, United States
While a key focus of e-labeling is how and when labels are converted from paper to digital, important aspects of e-labeling and its adoption go beyond the conversion itself. A key measure of value is patient benefit, including accessibility of elabeling across patient populations, interoperability across various points of care and care providers, and personalization to the individual patient. And a key enabler to driving forward e-labeling is Health Authority engagement and support. This session will address regulator interactions, early-stage developments, and global adoption patterns around e-labeling as well as patient benefits and interactions through key e-labeling initiatives.
Learning Objective : At the conclusion of this session, participants should be able to:- Discuss regulator interactions, early-stage developments, and global adoption patterns for e-labeling
- Identify key concepts and technologies related to interoperability across care platforms and within the end-to-end labeling process
- Describe select in-flight patient-focused e-labeling initiatives and their current status
Speaker(s)
Giovanna Ferrari, PHD
Regional Labelling Lead, Senior Director, Pfizer Ltd, United Kingdom
Gravitate-Health… Unlocking the Value in Electronic Product Information (ePI) for the Patient – Taking a Global Approach
Yuri Quintana, PHD
Chief, Division of Clinical Informatics, Beth Israel Deaconess Medical Center, United States
Co-Creating New Ways to Communicate Medication Information to Patients
G. Scott Gordon, PHD
Senior Health Informatics Officer, OSP, CDER, FDA, United States
FDA SPL-on-FHIR: Opportunities for Modernization and International Harmonization of Product Information
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