Description:
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 is 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.
Who Will Benefit:
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
International Trade Managers
Product specification developers
Agenda:
Day 1 Schedule
8:30 AM - 9:00 AM: Registration
9:00 AM - 10:30 AM
Lecture 1: 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
10:30 AM - 12:00 PM
Lecture 2: 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
12:00 PM - 1:00 PM Lunch
1:00 PM - 2:30 PM
Lecture 3: Supreme Court / commercial free speech
Constitutional protection and case law
Amarin Case: off-label, but true
Safe harbor
Policy
FDA organizational responsibility
FDA Guidance
2:30 PM - 2:45 PM Break
2:45 PM - 4:30 PM
Fair and balanced disclosure
Social media
Direct to Consumer Advertising
Hypothetical Workshop
Day 2 Schedule
9:00 AM - 10:30 AM
Lecture 1:
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
10:30 AM - 12:00 PM
Lecture 2: False and misleading information
Statutory basis (21 U.S.C. 352(a))
New use
Comparative claims
Claims for safety and effectiveness
Sales for solicitation
12:00 PM - 1:00 PM Lunch
1:00 PM - 2:30 PM
Lecture 3:
Off label use - practices and policy
FDA Warning Letters
2:30 PM - 2:45 PM Break
2:45 PM - 4:30 PM
Lecture 4:
Practice of medicine exemption
Custom Device promotion
(Group Hypothetical)
Corporate management responsibility
Speaker:
Casper Uldriks
ex-FDA Expert and former Associate Center Director of CDRH
Casper (Cap) Uldriks owns Encore Insight LLC, which provides consulting services on FDA Law. He brings over 32 years of experience from the FDA. He specialized in the FDA's medical device program as a field investigator, served as a senior manager in the Office of Compliance and as 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.
Location: SFO, CA Date: January 17th &18th, 2019 and Time: 9:00 AM to 6:00 PM
Venue: Hilton San Francisco Airport Bayfront 600 Airport Blvd, Burlingame, CA 94010
Price:
Register for 1 attendees Price: $2,000.00
Register for 5 attendees Price: $10,000.00
Register for 10 attendees Price: $20,000.00
Sponsorship Program benefits for seminar
For More Information- https://www.globalcompliancepanel.com/control/sponsorship
Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com
Registration Link - https://www.globalcompliancepanel.com/seminar/FDA-scrutiny-of-promotion-and-advertising-practices-901930SEMINAR?seo
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