2-day In-person Seminar

FDA Scrutiny of Promotion and Advertising Practices

Director :
Casper Uldriks

Date: June 27th & 28th, 2019
Time: 9:00 AM to 4:30 PM
Location: Baltimore, MD
Venue: The DoubleTree Baltimore-BWI Airport
Download:  Seminar Brochure

1 attendee

  • $2,000.
  • Register for 1 attendee

5 attendees

  • $10,000.
  • Register for 5 attendees

10 attendees

  • $20,000.
  • Register for 10 attendees
Course "FDA Scrutiny of Promotion and Advertising Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. This month, June 2019, the FDA and the FTC send joint warning letters to firms based on their use of social media to market their products. Firms now face a double legal hammer now. Sites such as Facebook, Instagram, and Twitter that endorse the firm and their e-liquid product, failed to convey the risk to health about nicotine.

Advertising and promotion boundaries for devices lacks clarity, which does not work in favor of the industry. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. For products that contain nicotine, the use of social media is now a clear regulatory target. Marketing and regulatory affairs departments must collaborate to avoid the hammer and new targets. The roadblock, however, is that marketing managers and regulatory affairs managers rarely reach common ground. This is a dangerous corporate struggle.


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.

Who Will Benefit:

  • 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
  • International Trade Managers
  • Product specification developers

Background:

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person's behavior and decision outcomes. The vehicle for communication has evolved dramatically over the past 100 years and continues to evolve at a rate faster than one can anticipate at times. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the legal field playing field involves other federal agencies and departments, and they work in concert with FDA. It has become very complicated and very costly if you knowingly or unknowing walk into a legal snare. This seminar is designed to bring you up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

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

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Phone: 1800 447 9407
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Group participations

Get fabulous discounts by participating in groups of two or more.

No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

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. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed.

Location: Baltimore, MD
Hotel: The DoubleTree Baltimore-BWI Airport 890 Elkridge Landing Road - Linthicum, MD 21090


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