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 PROMOTIONAL MEDICAL EDUCATION TACTICS: covers drug and device promotion, including speaker's bureaus, presentations at scientific meetings, contractual arrangements with speakers, consultants, ad board members, publication plans, speakers' fees, slide kits, gifts to HCPs, social events, sponsorships, MOA.

Comprehensive review of the DO’S AND DON’TS FOR PROMOTIONAL MEDICAL EDUCATION SCENARIOS: covers diverse scenarios related to tactical implementation.

Comprehensive review of the PHARMA CODE from the PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA) which represents research-based pharmaceutical and biotechnology companies. Covers selection, use and training of promotional education speakers and hiring of HCPs as consultants; comparative claims, promotional publications, videos and visuals, meeting venues, meals, events and gifts.

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.