The Regulatory Issues module is designed to assist the medical communications professional in understanding the Federal Drug Administration's (FDA's) jurisdiction over the dissemination of information about drug products and the governing regulations and guidance documents.
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.
Feedback from Our Participant(s)
I have found these modules to be indispensable for any individual in the role of a Medical Communications Professional (MCP) in the pharmaceutical industry, whether they be new to this role or a more seasoned colleague. I recommend this program be incorporated into a Medical Communications training plan for all MCP team members, as it covers the foundation work processes of a MCP's role very nicely. As a seasoned MCP myself, the modules were very helpful to identify how we are currently practicing, and where improvements could be made based on following the industry's best practices as it relates to medical communications. Also of great value, the ability to earn ACPE credit as a pharmacist as well as the opportunity to receive a DIA Medical Communications Certificate upon completion of all 9 modules, really adds credence to embarking on this educational opportunity as a "no-brainer".
- Law enforcement and prescription drugs
- Prescription drug advertising
- FDA role in drug approval and labeling
Who should attend?
New medical communications professionals
Upon completion of this course, you should be able to better perform the following functions:
- Explain FDA’s authority and jurisdiction under which it regulates the dissemination of information, including advertising and promotional labeling, about prescription drugs
- Explain the regulatory requirements for prescription drug advertisements and promotional labeling
- Explain the issues concerning the dissemination of information about a prescription drug product prior to its approval
- Explain the issues around special types of advertising and promotional events
- Explain on-label and off-label issues concerning approved prescription drugs and the issues concerning the dissemination of off-label information
- Explain issues concerning direct-to-consumer advertising of prescription drugs
- Describe the interests of FDA and other federal and state law enforcement agencies in monitoring the dissemination of information about prescription drugs
The module takes an average of 4.0 hours to complete. (Note that this is an average time. People learn at different rates, and they explore resources and examples at different paces.)