Product Labeling eLearning Module
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Product Labeling
Keyword(s)
Labeling, Medical Communications, Medical Affairs, Core Data Sheet, FDA, EMA, Product Labeling, Ad/promo
This module explains the need for, and definition of, labeling for prescription drugs and biologic products. It discusses how labeling is developed and maintained throughout the product’s marketed life, the components and structure of prescription drug and biological product labeling, and pertinent regulatory and legal requirements with which they must comply..Register Here!
Credit Information
ACPE = 3
IACET = .3
IACET = .3
Description
Learn how labeling is developed and maintained throughout the product’s marketed life, and the components and structure of prescription labeling.
Learning Objectives
Upon completion of this module, learners should be able to:
- Evaluate the purpose of prescription drug and biologic product labeling
- Compare labeling requirements at the global and local levels
- Identify the components of the Company Core Data Sheet (CCDS)
- Recognize the components, structure, and use of the Prescribing Information and the Medication Guide in the US
- Outline the components, structure, and use of the Prescribing Information (Summary of Product Characteristics) and Patient Labeling (Package Leaflet) in the European Union
- Identify the regulatory agencies and requirements that govern product labeling for non-US and EU European countries
- List the departments involved in labeling development and maintenance