ComplianceOnline

Course Description:

One of the biggest challenges in the dietary supplement industry is handling marketing and advertising. Marketers must build a strong campaign to differentiate their product from their competitors. They seek to find ideas and words to tout the benefits of their product through advertising. However, they must also comply with the laws and requirements for appropriate advertising. Within the US, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA), are responsible for enforcing the laws and regulations that dictate the boundaries of what the company can say when selling its products.

Supplement marketers must ensure that anyone involved in promoting products is familiar with basic FTC advertising principles. The FTC has taken action not just against supplement manufacturers, but also, in appropriate circumstances, against ad agencies, distributors, retailers, catalog companies, infomercial producers and others involved in deceptive promotions. Therefore, all parties who participate directly or indirectly in the marketing of dietary supplements have an obligation to make sure that claims are presented in a compliant manner.

On Day 1, you will gain an in-depth understanding of the FDA and FTC requirements for advertising and promotion of dietary supplements. Hands-on activities will allow you to use this understanding to evaluate promotional claims for compliance and discuss ways to turn non-compliant pieces around while still delivering a strong and robust marketing message.

On Day 2, we will discuss the elements of appropriate supportive evidence for making claims. You will gain practical experience by evaluating the supportive evidence behind proposed claims to determine if it is acceptable. Cases of non-compliance and the associated penalties will be reviewed. And, strategies for implementing an effective, internal review and approval process to ensure compliance will be discussed.



Learning Objectives:

After taking this seminar, participants will be able to understand:

  • How to develop compliant advertising claims
  • Level of support necessary for various types of claims
  • How to transform non-compliant claims
  • Approaches to implementing a review and approval process for proposed advertising

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



Seminar Benefits:

  • Understanding the laws and regulations that govern advertising and promotion of dietary supplements
  • Learn to transform non-compliant messages into compliant messages
  • Hands-on practical experience in evaluating supportive evidence for appropriateness
  • Implement programs and strategies to ensure compliance and negative regulatory actions


Areas Covered:

  • FDA and FTC requirements for advertising and promotion
  • How to evaluate promotional claims for compliance
  • How to turn non-compliant pieces around while still delivering a strong and robust marketing message
  • The elements of appropriate supportive evidence for making claims
  • How to evaluate the supportive evidence behind proposed claims to determine if it is acceptable
  • Review cases of non-compliance for learnings
  • How to implement an effective, internal review and approval process


Who will Benefit:

  • Regulatory Affairs
  • Legal Reviewers
  • Marketing
  • Advertising agencies who support dietary supplements
  • Medical Reviewers
  • Distributors
  • Management Decision Makers
  • Employees involved in the preparation and review of marketing materials




Course Outline:

Day 1 (8:30 AM – 4:30 PM) Day 2 (8:30 AM – 4:30 PM)
  • 8:30-9:00: Registration
  • 9:00-10:00: Overview of regulatory structure and the role of each regulatory agency
  • 10:00-10:45: Overview of foundational requirements for all advertising
  • 10:45-11:00: Break
  • 11:00-12:00: In depth review of specific requirements imposed by the FDA
  • 12:00-1:00: Lunch
  • 1:00-2:30: In depth review of FTC requirements for various claim types (structure/function, health, and nutrient content)
  • 2:30-4:30: Review example claims for compliance and discuss transformation of non-compliant claims
  • 8:30-9:00: Review of Day 1; Questions from Day 1; Review of Day 2 agenda
  • 9:00-9:30: Review the required elements of supportive evidence for making claims
  • 9:30-10:00: Examine various types of supportive documents and which claims they can support
  • 10:00-10:15: Break
  • 10:15-12:00: Evaluate supportive evidence behind specific claims to determine acceptability
  • 12:00-1:00: Lunch
  • 1:00-2:30: Review actual cases of non-compliance and discuss learnings from these cases
  • 2:30-2:45: Break
  • 2:45-4:30: Strategies for implementing an effective, internal review and approval process




Meet Your Instructor

Peggy J. Berry,
MBA, RAC, President & CEO, Synergy Consulting (Ex-FDA Official)

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book "Choosing the Right Regulatory Career" (RAPS, MD) and author of the 2011 book "Communication & Negotiation" (RAPS, MD).





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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).

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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 $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.

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

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Media Partners

Sponsors



Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.


Media Partner To Do
  • Banner (min 728x90 or 468x60) on the media partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the magazine and/or website.
  • Dedicated email blast to media partner’s subscribers.
  • Article on the magazine and/or website after the conference.






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