New FDA Guidance for Direct-to-Consumer Promotional Labeling and Advertisements

Duration: 90 Minutes
This course will provide a detailed overview of the new FDA guidance document in order to educate participates on the agency's recommendations and expectations in regard to Direct-to Consumer promotional labeling.
FDA Guidance on Promotional Labeling and Ads
Instructor: Kelly Thomas
Product ID: 504836
Objectives of the Presentation
  • Understand the regulatory requirements governing DTC promotional labeling
  • Understand how to apply those requirements
  • Explain the new regulatory expectations regarding how to present quantitative risk data
  • Understand the regulatory expectations regarding visual aids
  • Understand the consequences of non-compliance to DTC promotional labeling regulations
Why Should you Attend
The FDA released a new draft guidance document in October 2018 on the topic of efficacy and risk information in direct-to-consumer promotional labeling and advertisements. The guidance document provides industry with advice on how to present effectiveness and risk information in consumer ads in such a way that it is easily understood by consumers. It is essential that a product's benefits and risk are clear, concise and informative. Therefore, the goal of the new guidance is to provide industry professionals with the knowledge necessary to ensure that prescription drug promotional materials are truthful and not misleading; especially, in regard to a product's benefits and risks.

Areas Covered
Topic 1: Review History of DTC Promotional Labeling
  • A Decade of Evolving Regulation
Topic 2: Review DTC Promotional Labeling Regulatory Requirements
  • Food Drug & Cosmetics Act (FDCA)
  • 21 CFR 202
Topic 3: Review Concepts Detailed in the October 2018 FDA Guidance
  • How to present quantitative risk data so that it is understood by the consumer
  • Proper use of Visual Aids to illustrate quantitative efficacy or risk information
Topic 4: Understand the consequences of Non-Compliance
  • Review potential outcomes for Non-Compliance
  • Review Recent Regulatory Actions Regarding DTC Promotional Labeling Non-Compliance
    • FDA Enforcement Actions: Warning Letters, Consent Decrees, Injunctions, Seizers
Who will Benefit
  • Marketing managers
  • Regulatory affairs managers
  • In-house legal counsel
  • Third-party consultants
  • Own Label distributors
  • International trade managers
  • Product specification developers
  • Corporate web managers
  • Quality Assurance Departments
  • Regulatory Affairs Departments
  • Medical Affairs Departments
  • Marketing Departments
  • Program & Portfolio Management
  • Commercial/Corporate Compliance Departments
$200
Recorded Session for one participant
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Live Session - How it works
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  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
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