Seminar on Marketing Products without Getting Hammered by FDA

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.

GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost

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 1 Schedule:

• 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 2 Schedule:

• 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

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

Venue: DoubleTree by Hilton Hotel San Francisco Airport

Address: 835 Airport Blvd., Burlingame CA 94010-9949

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

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 GlobalCompliancePanel

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com      

Website: http://www.globalcompliancepanel.com/

Registration Link - http://bit.ly/Hammered-by-FDA-seminar