US Regulatory and Compliance Considerations
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 US FDA and its regulations. Other countries or regions have their own governing agencies with regulations that may or may not reflect those discussed here.
The module takes an average of 4 hours to complete.
This eLearning module can be purchased individually or as part of the Medical Communications eLearning Program (eight modules) or the Medical Affairs eLearning Program (11 modules).
- 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 Requests
- The On-Label and Off-Label Controversy
- Direct-To-Consumer Promotion
- Compliance and Other Law Enforcement Agencies
Who should attend?
This program is designed for professionals involved in:
- Medical affairs
- Medical communications
- Medical information
- Medical writing
- Field-based medical affairs support (i.e., Medical Science Liaison)
- Medical call center environment
- Regulatory affairs
- Clinical research
- Professional education, training, and development
- Document management/eSubmissions
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