Product Labeling

Learn how labeling is developed and maintained throughout the product’s marketed life, and the components and structure of prescription labeling.

参加申し込み

概要

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.

The module takes an average of 3 hours to complete.

This eLearning module can be purchased individually or as part of the Medical Communications eLearning Program (eight modules) or the Medical Affairs eLearning Program (11 modules).

参加対象

This program is designed for professionals involved in:

Medical affairs
Medical communications
Medical information
Medical writing
Field-based medical affairs support (i.e., medical science liaison)
Medical call center environment
Regulatory affairs
Clinical research
Professional education, training, and development
Document management/eSubmissions
Clinical safety and pharmacovigilance
Labeling
Marketing/Advertising
Ad/Promo

学習目的

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

参加申し込み

Product Labeling

概要

特集トピック

参加対象

学習目的

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