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.
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:
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.
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.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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