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Labeling is a critical tool for the safe and effective use of prescription drugs, biologics, and medical devices. Its purpose is to convey the essential information needed by providers, patients, and payers to make decisions about product access, prescription, and use. Today’s environment of increasingly complex labeling regulations and guidances is especially challenging for products marketed in multiple regions, which demand worldwide consistency of prescribing and patient information.
This Conference provides a forum for regulators and industry to update their knowledge of local and global labeling-related policies and to examine the impact of changes on regulatory compliance. Through expert panels and interactive discussions, participants will share approaches, processes, and tools to ensure effective labeling that meets regulatory expectations.
FEATURED TOPICS
- Global Labeling Issues and Updates
- Labeling Role
- Pharmacovigilance Risk Assessment
- Packaging Issues
- Combination Products
- Biosimilars
- Patient Leaflet
- Plain Language Labeling
- Patient Medication Information (PMI)
- International Strategic Plan
VENUE
Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road,
North Bethesda, MD 20852
USA