Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices: 2-day In-person Seminar
Thursday, October 3, 2013 at 8:30 AM - Friday, October 4, 2013 at 4:30 PM (PDT)
Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well as key recent trends in enforcement activities by the Federal Government. This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena.
What’s at stake if your advertising and promotional efforts violate the law? Colossal fines – the latest was $3 Billion; criminal liability, including even prison time; and huge disruption in operations while dealing with federal probes into illegal marketing.
Key goals of the conference will include learning:
- 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 distinctions between labels, labeling and advertising and how that impacts FDA's powers, and
- How to properly position Direct-to-Consumer (DTC) promotions
- The Dos and Don'ts of promoting products on the internet, including social media sites such as Facebook and Twitter
- The perils of off-label promotion, including criminal and civil actions that have led to multi-billion dollar settlements by regulated drug companies
- Whether the First Amendment provides any insulation for truthful statements regarding regulated products;
- When disseminating medical educational materials crosses the line into improper promotion; and
- 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 & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.