Overview of the government agencies/trade organizations that “regulate” drug and medical device promotion: FDA; OIG; PhRMA; AMA; and ACCME. 

Learn the basics for working within the regulated industry of healthcare, including government agency oversight, role of diverse stakeholders (e.g., HCPs, payers, patients, caregivers, industry, government), importance of confidentiality (with 10-question quiz). 

Overview of Physician Payments "Open Payments Program" (Sunshine Act), which requires manufacturers of drugs, medical devices/ biologicals that participate in U.S. federal health care programs to report certain payments/items of value given to physicians/teaching hospitals.

Overview of key elements of scientific exchange based on several FDA guidance documents including responding to unsolicited requests for off-label information about prescription drugs and medical devices and distributing scientific and medical publications on unapproved new uses – recommended practices. Covers range of activities including definition of scientific exchange and safe harbor, general guidelines for compliant content, responding to unsolicited questions for off-label, and distribution of scientific and medical publications on unapproved new uses.

Overview of referencing promotional materials for drugs and medical devices targeting consumers and healthcare professionals. Covers range of activities including reference types, reference selection, reference and promotional material annotating, reference citation guidelines, and guidelines for referencing material based on audience.

This course covers a range of activities for drugs and medical devices, including SWOT and gap analyses, congress strategy and initiatives for abstracts, posters, and presentations, manuscript development, authorship guidelines, journal selection, and publication management post-publication.

Comprehensive review of the Do's and Don'ts for Public Relations Tactic: covers drug and device promotion, including press releases, VNRs, media tours, web sites and webcasts, spokespeople, media training, sponsored content/advertorials.

Comprehensive review of the Do's and Don'ts for Public Relations Tactic: covers drug and device promotion, including press releases, VNRs, media tours, web sites and webcasts, spokespeople, media training, sponsored content/advertorials.