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CCC eLearning Certificate Program

Promotional Regulatory Compliance for
Public Relations in the United States:
Fundamental Requirements for Marketing Drugs and Devices

Overview

This eLearning Certificate Program addresses the compliant uses of Public Relations when marketing pharmaceutical, biotech and biologic drugs, and medical devices. Expert-reviewed programs cover the complex landscape of regulations, guidelines, codes and guidances designed to ensure that prescription product information is truthful, balanced, and accurately communicated. Testing confirms mastery of the material upon successful completion of the program.

Featured Topics

  • U.S. regulatory environment affecting the promotion of prescription medical products
  • FDA rules and relevant guidances pertaining to advertising/promotion
  • Guidelines and codes for interaction with healthcare professionals (HCPs)
  • On-label and off-label communications
  • Compliant advertising and promotional tactics and scenarios
  • Compliant advertising and promotional tactics and scenarios

Target Audience

Professionals employed by manufacturers of prescription products, as well as their consultants and promotional agencies, who design, review, approve, execute or oversee public relations materials, tactics, programs or campaigns.

Learning Objectives

Upon completion of this program, participants will be able to:

  • Describe the regulatory and legal environments affecting public relations for medical products marketed in the U.S., including pharmaceutical, biotechnology and biologic drugs, and medical devices
  • Understand the regulations, guidelines, codes and guidances pertaining to public relations materials and campaigns
  • Discuss fundamental compliance considerations that inform decisions regarding public relations
  • Identify the risks and potential consequences of non-compliance with regulatory requirements for public relations materials and campaigns
  • Apply appropriate regulations, guidelines, codes and guidances to the compliant development and execution of commonly used public relations materials, formats and campaigns
  • Analyze the enforcement actions of FDA/Office of Prescription Drug Promotion (OPDP) to learn what might be applied to public relations

Requirements for Certificate of Mastery

  • Five modules, ~30 minutes each
    • Regulatory Environment
    • FDA Oversight
    • FDA Guidances
    • Tactics
    • Scenarios
  • Regulatory Compliance Test (RCT) - 50 questions

Program Format

  • 24/7 access from CCC website

Program Reviewer

This eLearning Certificate program has been reviewed by Wayne Pines, a nationally-recognized expert in regulatory aspects of healthcare advertising and promotion. Wayne served at the U.S. Food and Drug Administration, FDA, for ten years. He was the Agency's Chief of Consumer Education and Information, Chief of Press Relations, and Associate Commissioner for Public Affairs. Wayne was the FDA's spokesperson to the media for seven years, and in 2004, he was named FDA's Alumnus of the Year. Wayne is the author of the standard reference book in the field, The FDA Advertising and Promotion Manual, as well as chapters in other books. He serves on promotional review committees for drug and device companies and conducts training programs for them.

Special Recognition

The Coalition for Healthcare Communication (CHC) is partnering with CCC to offer the company's eLearning programs to healthcare agencies and publishers. Founded in 1991, CHC is a not-for-profit organization whose members include the leading healthcare marketing agencies and medical publishers. CHC members receive special discounts on coursework.