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US Regulatory and Compliance Considerations


Overview

This module is part of the Medical Communications eLearning Program (eight modules) and will help the medical affairs professional to understand and comply with regulations guidance around the dissemination of information about drug products.  It focuses on the United States FDA and its regulations.

Featured topics

  • FDA regulatory standards for advertising and promotional labeling
  • Requirements for advertising and promotional labeling
  • Special types of advertising and promotional events
  • Promotion versus scientific exchange
  • The on-label and off-label controversy
  • Direct-to-consumer promotion
  • Compliance

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:

  • Explain FDA’s authority and jurisdiction under which it regulates the dissemination of information, including advertising and promotional labeling, about prescription drugs
  • Explain the regulatory requirements for prescription drug advertisements and promotional labeling
  • Explain the issues concerning the dissemination of information about a prescription drug product prior to its approval
  • Explain the issues around special types of advertising and promotional events, including the Physician Financial Transparency Reports (also known as the Physician Payments Sunshine Act), and how they relate to physician customers
  • Explain on-label and off-label issues concerning approved prescription drugs and the issues concerning the dissemination of off-label information
  • Explain corporate integrity agreements
  • Explain the issues concerning direct-to-consumer advertising of prescription drugs
  • Describe the interests of FDA and other federal and state law enforcement agencies in monitoring the dissemination of information about prescriptions drugs


This module takes an average of 4 hours to complete.

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