ComplianceOnline

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 unwelcomed 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.

Seminar Instructor Casper Uldriks is an "Ex-FDA Official" who has spent 32 years in FDA and his engagements focus on advertising and promotion, recalls, corrections and removals and enforcement. He currently trains FDA personnel and counsels clients on wide range of topics, including: FDA inspections; import operations; advertising and promotion; corrective and preventive actions; medical device reporting and corporate reorganization to improve conformance to the FDA’s requirements.

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.
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who will Benefit:

  • Sales and Marketing executives and managers
  • Regulatory Managers
  • In-house Legal Counsel and Contract Specialists
  • 3rtd party consultants
  • Venture Capitalists
  • Investors
  • Business Acquisition Executives
  • Owners of New or Developing Firms
  • Own label distributors
  • International Trade Managers
  • Product specification developers

Topic 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.

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Day 01(8:30 AM - 4:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  • 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 02(8:30 AM - 4:30 PM)
  • 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
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Casper (Cap) Uldriks

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

Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” 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 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. 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.

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Register Now

Online using Credit card

$1,699.00

Seminar One Registration

January 24-25, 2017, San Francisco, CA
(For Registrations till December 15, 2016 - $1699)
(For Registrations till January 7, 2017 - $1899)
(For Registrations after January 7, 2017 - $1999)

$2,299.00

Seminar One Registration (With 2 Nights Stay)

January 24-25, 2017, San Francisco, CA

$7,799.00
$10,194.00 (23%)*

Save $2,395.00

Special Group Discount Register for Six attendees

January 24-25, 2017, San Francisco, CA
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left




Early bird seats are limited and based on first-come, first-serve.

The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both days.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

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Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 200
Palo Alto, CA 94303
USA

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Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Location

Hilton San Francisco Airport Bayfront
600 Airport Blvd,
Burlingame, California, 94010, United States
Tel:650-340-8500

January 24-25, 2017

How to Reach

General Driving Directions:

Driving directions from San Francisco International Airport – 4 miles:
  • Exit airport 101 South towards San Jose.
  • Take Broadway/Burlingame exit.
  • Take 2nd right to overpass to other side of freeway. 1st light, turn right.
  • Next light turn left onto Airport Blvd. Hotel is located in 1 mile.
Driving directions from San Jose International Airport – 32 miles:
  • Start out going Southeast on Airport Blvd.
  • Turn slight Left to CA-87/ Skyport Dr.
  • Merge onto CA -87 N. via the ramp to US-101 N.
  • Take US-101 N. Take Anza exit and turn right on Airport Blvd. Hotel is on the left.
Driving directions from Metropolitan Oakland International – 32 miles:
  • Exit airport and turn left onto Davis/CA-61.
  • Merge onto I-880 toward San Jose.
  • Take exit 27 toward CA-92 toward San Mateo/Half Moon Bay.
  • Cross the bridge and merge onto US-101 N. Exit Peninsula Ave, exit 417B. Left on Airport to the hotel.

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Media Partners
Platinum Partner
  • Logo on name cards
  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
  • Moving banner ad on the website
Gold Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website
Silver Partner
  • Logo on name cards
  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
  • Moving banner ad on the website
Bronze Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert

If you wish to partner with us for this event please contact us: partner@complianceonline.com or call us: +1-888-717-2436.

Sponsors
Platinum Partner
  • Logo on name cards
  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
Gold Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website
Silver Partner
  • Logo on name cards
  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
  • Moving banner ad on the website
Bronze Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website

If you wish to sponsor this event please contact Cruise Webster: cwebster@complianceonline.com or call us: (207) 576-4173

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

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