Product Labeling
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Product Labeling
Keyword(s)
Labeling; Medical Communications; Medical Affairs; Core Data Sheet; FDA; EMA; Product Labeling; Ad/promo
This module provides an overview of the importance and definition of labeling for prescription drugs and biologic products. It covers the development and maintenance of labeling throughout the product's lifecycle, the components and structure of prescription drug and biological product labeling, as well as the relevant regulatory and legal requirements that must be met.Register Here
Credit Information
3.0 ACPE
0.3 IACET
0.3 IACET
Description
FEATURED TOPICS
- Global Labeling: The Company Core Data Sheet
- Labeling in the US: Prescribing Information and the Medication Guide
- Labeling in the European Union: The Summary of Product Characteristics and Package Leaflet
- Labeling in Non-US and Non-EU Countries
- Maintenance of Product Labeling
- Case Studies