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Regulatory Aspects of Prescription Drug/Biologics Advertising and Promotional Labeling


Continuing Education Credits are not available for the archived offering.
This program is a part of DIA's Certificate Program and is awarded the following:
Regulatory Affairs Certificate Program: 2 Core Units
For more information go to

This archive may be purchased through June 4, 2015.
Archive duration:
Part 1: 1 hour 53 minutes

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.

Course Level: Beginner

Featured topics

  • Definitions
  • Statutory Basis for Promotional Regulations
  • Required Elements for Advertisements
  • Reminder Advertisements/Labeling
  • Direct-to-Consumer Advertising
  • Social Media
  • Disease Awareness/Help-Seeking
  • Launch Promotional Pieces
  • Postmarketing Submission of Advertising
  • Preapproval Promotion and Dissemination of Off-Label Information
  • FDA Enforcement Actions
  • Summary of Principles for Advertising and Promotion

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

Contact us

Printable Registration Form

Registration Questions and
Technical Support

Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET

Agenda and Event Logistics
Susan Berkelbach, Event Planner
Phone +1.215.442.6183
Fax +1.215.442.6199

Ways to register

 Printable Registration Form

  • Individual registration is a license for ONE internet login allowing one viewer.
  • Group site registration is a license for ONE internet login allowing multiple viewers from one location.

Cancellations:  No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.

Participants with Disabilities:  Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs