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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.
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:
Areas Covered in the Webinar:
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.
Dr. Michael C. Redmond, PhD, is a certified project manager, PMP, has two master certifications in business continuity/disaster recovery MBCP and FBCI and is certified in emergency management. She is active in cyber security and holds multiple ISO certifications (ISO/IEC 27001 Information Security Management, ISO/IEC 27032 Lead Cyber Security Manger, ISO/IEC 27035 Security Incident Response, ISO/IEC 22301 Business Continuity Management Systems, ISO/IEC 21500 Project Management, and ISO/IEC 41001 Environmental Management). She is an international consultant, speaker and published author.
Michael's MBA in Risk Management included courses in Information Security and Risk Management for Medical Devices and Healthcare. Michael is certified as a Senior Lead Manager in Information Security for Healthcare ISO 27999.As a practitioner, she has been implementing ISO 27999 and ISO 14971 for over 10 years for clients.
Her past experience includes 13 years as a senior manager with Deloitte, KPMG and Chubb in the areas of: compliance, crisis management, business continuity, disaster recovery, emergency management, internal audit/ gap analysis. She was a business continuity/disaster recovery manager with the Bank of New York. She consults for clients in diverse industries such as banking, manufacturing, pharmaceutical, hospitals, government agencies, colleges and universities, law firms, and media.
Dr. Redmond spent 4 years on active duty with the army and 18 1/2 years as National Guard and Reserve before retiring as a major. She is a graduate of Command & General Staff College (Fort Leavenworth), attended civil affairs courses at the US Army JFK School of Special Warfare and is Hazmat trained and DOD certified. The White House honored Dr. Redmond at a luncheon as one of the Top Women in Her Field of Business Continuity.