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Who should attend FDA Scrutiny of Promotion and Advertising Practices
Sales and Marketing executives and managers, Regulatory Managers, In-house Legal Counsel and Contract Specialists, 3rd party consultants, Venture Capitalists, Investors, Business Acquisition Executives, Owners of New or Developing Firms, Own label distributors
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Seminar Summary:

This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept (see full course description)

 
 
 

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Training Course Syllabus:


FDA Scrutiny of Promotion and Advertising Practices: 2-Day In-Person Seminar by Ex-FDA Official

By: Casper (Cap) Uldriks, Former Associate Center Director of FDA's CDRH

Course Description:

If you go "off label" with advertising and promotion, you become embroiled in FDA´s advertising and promotion requirements. For devices, the law is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments need to collaborate now more than ever before. Firms need to identify practical criteria to make marketing decisions. The big question is whether or not marketing managers and regulatory affairs managers will really try to reach common ground. FDA´s Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. 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. Bottom line, do you know when you are running afoul of FDA´s requirements or are you guessing? Can you afford to guess? The cost to your business and the confusion left in your customer's mind becomes an unwelcome nightmare.

With 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 now 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. What is more challenging is whether a consumer's mind makes its decisions on what it learns versus pre-existing emotional factors that may or may not be conscious.

This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm´s regulatory profile for advertising and promotion practices. What is not so easy is to know is how the potential customer or existing user will actually make their decision and act on it.

Learning Objective:

  • 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

FDA Scrutiny of Promotion and Advertising Practices Course Outline:

Day One (8.30AM – 4.30PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

FDA legal authority
FDA application of the FD&C Act and implementing regulations
FTC / mass media
SEC/False statements
DOJ / False Claims
Enforcement authority and options
Cognitive psychology vs. psychoanalytic motivation
Promotion and Advertising: scope of labeling
Definitions for “label” and “labeling”
Hard copy and electronic
Testimonials
Blogs
Sales force
What is “off-label”?
Practice of Medicine exemption
Drugs authority
Devices
Dietary supplements
Supreme Court / commercial free speech
Constitutional protection
Safe harbor
Policy
FDA organizational responsibility
FDA Guidance
Fair and balanced disclosure
Social media
Direct to Consumer Advertising
Hypothetical Workshop

Day Two (8.30AM – 4.30PM)

Direct to consumer advertising vectors
Federal Trade Commission interest (economic vs. safety)
Context and format of messaging
Script versus message
Target population
Aspirations
Emotional factors
False and misleading information
Statutory basis (21 U.S.C. 352(a))
New use
Comparative claims
Claims for safety and effectiveness
Sales for solicitation
Off label use
Practice of medicine exemption
Custom Device promotion
(Group Hypothetical)
FDA Warning Letters
Corporate management responsibility


Seminar Summary:

This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept (see full course description)

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