UCSC Extension Course, Two Saturdays, Nov. 7 and 14, 2009
Course Title: Regulation of Biomedical Products Advertising, Promotion, and Labeling (Course Code: 20756-005)
Dates & Time: Saturdays, Nov. 7 & Nov. 14, 2009, 8:30AM to 5:00PM
Where: UC Santa Cruz Extension, Santa Clara Campus
New Location: 2505 Augustine Dr, Santa Clara, CA
Speaker (s) – Joyce L Chiarenza, Instructor, and one guest speaker
Cost: $560 Tuition
See www.ucsc-extension.edu/biosciences for course descriptions and links to all of our bioscience certificate programs. Questions? E-mail biosciences@ucsc-extension.edu or call 408-861-3860.
Course Description:
The biomedical industry offers numerous examples of what not to do when it comes to advertising, promotion, and labeling. Drawing on real-world cases in the public domain, this workshop-format course unravels the mysteries of advertising and promotional regulations and guidance documents, and provides hands-on experience with their interpretation and practical application. Participants learn what gives regulators the grounds to take action on violative materials, and they gain an appreciation of the risk levels inherent in various promotional strategies. The instructor highlights the dynamic between regulatory professionals and the marketing, medical communications, and corporate communications departments, and offers tools for effective partnering around their joint advertising, promotion, and labeling activities.
This course will benefit regulatory, medical, legal, marketing, and sales professionals responsible for the review of materials used in the promotion of prescription and OTC drug, biologic, medical device and diagnostic products.
Instructor Background
Joyce L. Chiarenza, B.S., has 39 years of experience in the pharmaceutical and biotech industries, during which she has held senior positions in quality control, quality assurance, compliance and regulatory affairs. After more than 16 years at Genentech, Inc., she began her consulting practice, where she specializes in labeling, advertising and promotion. Joyce also held several quality positions with Abbott Laboratories and has experience with vitamins, food supplements and cosmetics.
