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

11:30 AM ET | 08:30 AM PT | 10:00 AM CT Duration 60 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

"Ms. Kelly Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations."

Detailed overview of the new FDA guidance document in order to educate participates on the agency’s

Description

The FDA released a new draft guidance document in October 2018 on the topic of efficacy and risk information in direct-to-consumer promotional labeling and advertisements.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.

Why should you attend

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.

Course Participates will:

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

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 
o FDA Enforcement Actions: Warning Letters, Consent Decrees, Injunctions, Seizers

Who will Benefit

•         Quality Assurance
•         Regulatory Affairs

Industries who can attend

This 60 minute online course is intended for professionals in the Pharmaceutical and Biopharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Kelly Thomas

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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