FDA Scrutiny of Promotion and Advertising Practices is organized by GlobalCompliancePanel and will be held during May 17 - 18, 2018 at DoubleTree by Hilton Hotel Philadelphia Airport, Philadelphia, Pennsylvania, United States of America. This CME Conference has been approved for a maximum of 12 Credits.
Who Will Benefit:
• Sales and Marketing executives and managers
• Regulatory Managers
• In-house Legal Counsel and Contract Specialists
• 3rd party consultants
• Venture Capitalists
• Business Acquisition Executives
• Owners of New or Developing Firms
• Own label distributors
• International Trade Managers
• Product specification developers
If you go "off-label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices are weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other.
FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. In contrast, FDA's Center for Drug Evaluation and Research (CDER) uses long-standing regulations and a growing number of guidance documents in its regulatory approach. Policing social media has become a new regulatory responsibility and FDA is still trying to figure out how to deal with it. Bottom line, do you know when you fail to meet FDA's requirements or are you guessing? Can you afford to guess? The cost to your business and the confusion left in your customers' mind becomes an unwelcomed nightmare.
In this seminar, you will learn how to navigate FDA's numerous legal options and how to interpret them based on basic legal principles. Applying new guidance documents becomes a new test of the FDA's legal boundaries and enforcement options. The agency is now conducting clinical studies and applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This academic discipline may or may not get to the root of what consumers take away as the message.
• Learn how FDA faces constitutional constraints on enforcement decisions
• Learn about intersecting federal requirements by the Department of Justice, the Federal Trade Commission, the Securities and Exchange Commission and the Consumer Product Safety Commission
• Learn how the FDA interprets advertising and promotion in principle and in fact
• Understand ways that a firm violates FDA requirements
• Evaluate advertising and promotional material based on interactive group hypotheticals
• See how sales and marketing departments play a central role, for better or worse
• Learn how the federal government holds executive management responsible for missteps in promotion and advertising practices.
Additional details will be posted as soon as they are available.
|Registration Type||End Date||Price|
|Course - Early Fee||10 Apr,2018||USD 1295.00|
|Course - Regular Fee||15 May,2018||USD 1495.00|
|Register for 5 attendees - Fee||15 May,2018||USD 3885.00|
|Register for 10 attendees - Fee||15 May,2018||USD 7122.00|