Course "Marketing Products without Getting Hammered by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA's legal corral.

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.

Why should you attend:

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, FDA's law and regulations are extensive and have violated Constitutional protections. Depending on your point of FDA's promotion and advertising requirements can help you or hurt you? There is an inherent conflict in interests. In any case, you need to identify practical criteria to make marketing decisions. That begs the question of whether or not marketing managers and regulatory affairs managers will even try to agree on an issue. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. CDER has established a pervasive and expanding program. For example, 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? It's become a brooding nightmare for you and consumers.

Areas Covered in the Session:

• FDA's legal authority and Constitutional limitations
• FDA requirements and exemptions
• FDA guidance documents, such as for social media, direct -to-consumer advertising, message formatting and providing risk/benefit information
• Warning Letters

Who will benefit:

• Regulatory Affairs
• Quality Assurance
• Manufacturing
• FDA Consultants and Legal Counsel

Agenda:

Day One

Lecture 1:

• FDA legal authority
  • FTC / mass media
  • DOJ / False Claims
  • FDA application of the FD&C statute and regulations
  • False and Misleading
• Cognitive psychology
• 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
    • Balanced disclosure of risk vs. benefit
  • Social Media
  • Direct to Consumer Advertising
• Hypothetical Workshop

Day Two

• Direct to consumer advertising
• Federal Trade Commission authority
• Fair and balanced information
• Context and format
• 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
• (Group Hypothetical)

• FDA Warning Letters
• Corporate management responsibility
  • FDA - false and misleading
  • FTC - false advertising
  • DOJ - false claims

Speaker:

Casper (Cap) Uldriks, through his firm "Encore Insight LLC," brings over 32 years of experience from the FDA. As an investigator, he was responsible for countless 483s, scores of Warning Letters, injunctions, individual seizures, mass seizures and was coined by industry as FDA's "Darth Vader." He inspected foods, drugs, methadone clinics and clinical investigators, but specialized in the FDA's medical device program. He served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements for FDA. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA's domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.

Location: SFO, CA Date: May 26th & 27th, 2016 and Time: 9:00 AM to 6:00 PM

Venue: DoubleTree by Hilton Hotel San Francisco Airport   835 Airport Blvd., Burlingame CA 94010-9949

Price Details:

(Seminar Fee for One Delegate)-Price: $1,295.00  

Until April 10, Early Bird Price: $1,295.00 from April 11 to May 24, Regular Price: $1,495.00

Quick Contact:

NetZealous DBA as MentorHealth

Phone: 1-800-385-1607

Email: [email protected]

Website: http://www.mentorhealth.com/

Registration Link - http://www.mentorhealth.com/control/globalseminars/~product_id=200042SEMINAR

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