US Regulatory and Compliance Considerations eLearning Module

Keyword(s) Medical Communications; Medical Affairs; eLearning; DIA; literature searching; Medical Information; online learning; US Regulations; compliance; FDA; pharmaceutical advertising

The goal of this module is to assist the medical affairs professional understand and comply with regulations and guidance around the dissemination of information about drug products.

Note that this module focuses on the United States FDA and its regulations. Other countries or regions have their own governing agencies with regulations that may or may not reflect those discussed here.

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Credit Information ACPE = 4
IACET = .4

Tag(s) eLearning, Medical Affairs, Medical Writing, Medical Communications, Clinical Research

Description

Part of the DIA Medical Communications eLearning Program

Learning Objectives

Identify the authority and jurisdiction under which the FDA regulates the dissemination of information, including advertising and promotional labeling, about prescription drugs
Recognize the regulatory requirements for prescription drug advertisements and promotional labeling
Define the issues concerning the dissemination of information about a prescription drug product prior to its approval
Determine issues around special types of advertising and promotional events, including the Sunshine Act (better known as Open Payments), and how they relate to HCP customers
Identify on-label and off-label issues concerning approved prescription drugs and the issues concerning the dissemination of off-label information
Recognize corporate integrity agreements
Define the issues concerning direct-to-consumer advertising of prescription drugs
Determine the interests of FDA and other federal and state law enforcement agencies in monitoring the dissemination of information about prescriptions drugs

Featured Topics:

FDA Jurisdiction Over Prescription Drug Advertising and Promotional Labeling
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 and Solicited versus Unsolicited Information
The On-Label and Off-Label Controversy
Direct-To-Consumer Promotion
Compliance and Other Law Enforcement Agencies

This module takes an average of 4 hours to complete.