Labeling, Advertising and Promotion in the Regulated Environment

Why Should You Attend:

Target Product Profile (TPP) development assists the manufacturer as well as the regulators with alignment throughout the labeling development program. The TPP is designed to reduce surprises along the way, and create a positive working relationship between the regulatory body and the manufacturer.

A TPP ultimately results in an approved final label, which then creates the basis for all advertising and promotional material for a product. Advertising and Promotion of drugs, biologics and medical devices is tightly regulated and any messaging must be fair and balanced. Examples of problematic advertising and promotion are provided with a review of why and how FDA addressed the issues with the companies responsible. How the new guidance “Medical Product Communications that are Consistent with the FDA-Required Labeling” is addressing First Amendment rights.

Key topics covered in this conference include:

• History of Advertising and Promotion Regulations – the Why?
• Who is regulating?
• Why is the label so important?
• What is a TPP and how does it work?
• What is the benefit of the TPP?
• What is going on with Freedom of Speech?
• What about Social Media?
• How do the regulatory bodies find out?
• What are regulatory bodies looking for?
• What about Medical Education?
• What happens to companies that cross the line?
• How to control materials within a company?

Areas Covered in the Webinar:

• History of why regulations were implemented
• Who is monitoring labeling, Advertising and Promotion of drugs, biologics and medical devices?
• Target Product Profile development and progression.
• Labeling development and progression.
• Advertising and Promotion development and compliance.
• Medical Education – what part does it play?
• What is reviewed as part of Advertising and Promotion of drugs, biologics and medical devices?
• Examples of materials in violation of applicable regulations
• Consistency guidance overview
• Corrections required of those in violation of regulatory requirements, including but not limited to notifications, fines and prison

Frequently Asked Questions:

1. What protocol needs to be followed to get a medical device approved?
2. Is nutritional Labelling a legal requirement?
3. Why doesn't Drugs @FDA include dietary supplements?

Who will benefit:

Those individuals within the biologic, drug and medical device firms responsible for developing labeling for drugs, biologics and medical devices. Those individuals within the biologic, drug and medical device firms responsible for developing advertising and promotional materials for drugs, biologics and medical devices such as marketing. These areas include but are not limited to marketing, commercial operations, sales, medical affairs, professional services, medical education, legal, regulatory and compliance.

Susanne Steiner
Associate Director, MannKind Corporation

Susanne Steiner, MBA has been working in the biologics, drug and medical device industry for over twenty years. She has been the FDA point of contact for labeling, advertising and promotional materials in development as well as for commercial product. She has chaired promotional review committee meetings and effectively collaborated with cross-functional internal groups. She has provided regulatory guidance in multiple corporations for the development, review, implementation, and maintenance of promotional materials and other related activities. She currently works in the drug/device industry and serves as a guest lecturer at the University of Washington for the Master’s of Bioengineering program.

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