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Overview

The Product Labeling module is designed to familiarize medical communications professionals with the components and structure of the prescription drug label and the medication guide, plus all pertinent regulatory and legal requirements with which they must comply. Learn the historical background and gain perspectives on the events that have culminated in current food and drug laws.


Feedback from Our Participant(s)

I have found these modules to be indispensable for any individual in the role of a Medical Communications Professional (MCP) in the pharmaceutical industry, whether they be new to this role or a more seasoned colleague.  I recommend this program be incorporated into a Medical Communications training plan for all MCP team members, as it covers the foundation work processes of a MCP's role very nicely.  As a seasoned MCP myself, the modules were very helpful to identify how we are currently practicing, and where improvements could be made based on following the industry's best practices as it relates to medical communications.  Also of great value, the ability to earn ACPE credit as a pharmacist as well as the opportunity to receive a DIA Medical Communications Certificate upon completion of all 9 modules, really adds credence to embarking on this educational opportunity as a "no-brainer".

Featured topics

  • FDA regulation of drugs
  • Prescription drug labels
  • Medication guide structure and use

Who should attend?

New medical communications professionals

Learning objectives

Upon completion of this course, you should be able to better perform the following functions:

  • Discuss the laws that FDA regulates and FDA's responsibilities
  • Discuss the major events that have driven FDA regulation of drugs and drug labeling
  • Explain the organization of the Federal Register and the Code of Federal Regulations
  • Identify the components and explain the structure and use of the Package Insert
  • Identify the components and explain the structure and use of the Medication Guide
  • Discuss the concepts behind the proposed changes to the requirements for package insert labeling

The module takes an average of two hours to complete.

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