Statistics for Medical Affairs eLearning Module
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This module is designed to help medical affairs professionals and others in the pharmaceutical industry evaluate statistical data presented in medical literature. It will help users apply statistical concepts when evaluating literature, identify strengths and weaknesses in study design, and detect potential bias in the presentation of statistics.Register Here!
Credit Information
4 ACPE
.4 IACET
.4 IACET
Description
Learning Objectives:
Upon completion of this module, learners should be able to:
- 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