Labeling, Advertising and Promotion of drugs, biologics and medical devices are heavily regulated and aggressively reviewed on behalf of the regulators such as FDA, FTC and other Federal Authorities. This course provides an overview of label development, building a Target Product Profile, the label’s impact on advertising and promotion, and recent changes in how these areas are monitored and enforced.
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.
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
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.Course Provider
Susanne Steiner,
