Overview of the GOVERNMENT AGENCIES/TRADE ORGANIZATIONS that “regulate” drug and medical device promotion: FDA; OIG; PhRMA; AMA; and ACCME.

Detailed review of CONTENT DO’S AND DON’TS including comparative/superiority, charts/graphs, competitor information, “cherry-picking”, disclaimers, references, market research data, quality-of-life claims, company spokespeople.

Detailed review of HOW TO COMMUNICATE RISK INFORMATION, including the definition and execution of fair balance in promotional materials. Common terms will be defined and illustrated, including Brief Summary, Boxed Warning, Important Safety Information (ISI) and Adverse event (AE) reporting. Examples of enforcement letters will illustrate the application of these requirements.

A recap of relevant FDA guidances which represent FDA’s perspective on compliant, tactical execution.

Comprehensive review of the DO’S AND DON’TS FOR PUBLIC RELATIONS TACTICS: 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 SCENARIOS: covers diverse scenarios related to tactical implementation.