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Regulatory Aspects of Prescription Drug/Biologics Advertising and Promotional Labeling


This course will provide you with the fundamentals on FDA regulations and guidance related to prescription drug advertising and promotional labeling. You will learn how to apply this information when you serve as a Regulatory representative for promotional review committees that assess traditional and newer forms of promotional materials for compliance. The course will also provide you with the information you need to ensure that other related pharmaceutical industry activities are conducted appropriately, and are not regarded as violative promotion.

Featured topics

  • Statutory Basis for Promotional Regulations
  • Required Elements for Advertisements and Promotional Labeling
  • Reminder Advertisements/Labeling
  • Preapproval Promotional Activities
  • FDA Enforcement Actions
  • Launch Promotional Pieces
  • Postmarketing Submission of Advertising

Who should attend?

This course is designed for individuals in pharmaceutical biologics and medical device companies and organizations involved in:

  • Marketing
  • Legal
  • Regulatory
  • Public relations/affairs
  • Advertising
  • Compliance
  • Management

Learning objectives

At the conclusion of this activity, participants should be able to:

  • Explain the regulatory requirements for prescription drug advertising and promotional labeling, including pre-approval promotional activities
  • Summarize the principles for advertising and promotion
  • List the required elements for advertisements and promotional labeling

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