Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices

Key Topics

• The distinctions between labels, labeling and advertising and how that impacts FDA`s powers, and
• The basics of FDA law and regulations governing advertising and promotion, as well as sister agencies such as the Federal Trade Commission, which shares jurisdiction with FDA on certain regulated products (e.g., OTC drugs)
• The Dos and Don`ts of promoting products on the internet, including social media sites such as Facebook and Twitter
• How to properly position Direct-to-Consumer (DTC) promotions
• Whether the First Amendment provides any insulation for truthful statements regarding regulated products
• The perils of off-label promotion, including criminal and civil actions that have led to multi-billion dollar settlements by regulated drug companies
• Key considerations on how to implement appropriate procedures and controls in your company to minimize the potential for regulatory action by the FDA or the FTC relative to promotion and advertising
• When disseminating medical educational materials crosses the line into improper promotion; and

Who should Attend

Directors, Senior executives, managers and those responsible or involved in advertising and promotional activities for drug and device firms, including attendees from regulated companies involved in Marketing, Sales, Legal, Medical Affairs, Compliance and Regulatory.