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Product Labeling


Overview

This module is part of the Medical Communications eLearning Program (eight modules) and 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.

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
  • Labeling in non-US and non-EU countries

Who should attend?

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

Learning objectives

Upon completion of this module, learners should be able to:

  • Define prescription drug/medicinal product labeling and describe the purpose of it
  • Describe labeling requirements at the global and local levels
  • Define and identify the components of the company core data sheet (CCDS)
  • Identify the components and explain the structure and use of the Prescribing Information and the Medication Guide in the US
  • Identify the components and explain the structure and use of the Prescribing Information in the European Union
  • Identify the regulatory agency that governs product labeling, the format for labeling, and where to find the regulations/guidance for labeling for non-EU European countries, Canada, Japan, South Africa, Australia, Saudi Arabia, Brazil, China, India, and South Korea
  • Describe the maintenance of product labeling

This module takes an average of 2.5 hours to complete.


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