This track will provide the professionals responsible for the advertising and promotion of medical devices with the background to get the most out of the main conference and know how to ensure that medical device communications comply with all relevant standards.
At the conclusion of this track, the participant should be able to:
Describe the scope of the FDA's authority over medical device promotion
Apply the relevant FDA standards to promotional messages about medical devices
Identify when to look to other agencies (especially FTC) for promotional standards
Drug Promotion Track Highlights
This course is designed to provide background information for you to better understand the conference content. The leaders will provide an introductory foundation for anyone working in our current regulatory environment. Whether you are a regulatory, legal, medical, compliance, or marketing professional, the information will be interesting, practical, and vital.
At the conclusion of this track, participants should be able to:
Discuss the current regulatory/compliance environment pertaining to the advertising and promotion of prescription drugs, vaccines, and biologics
Describe FDA advertising and promotional requirements, including claim support requirements, fair balance expectations, internet and social media challenges, product booths at medical conventions, adherence and preference programs, patient involvement and outreach, disease state programs, and public relations challenges
Assess the importance of the promotional review process, and be equipped to serve as a leading member of a promotional review committee