Overview:
Although FDA does not have statutory authority to regulate advertising and promotional activities per se, FDA does regulate the labeling of medical products. And since the courts have held that most, if not all, advertising and promotional activities are labeling, FDA is very interested in what you say about your products in the marketplace, to customers, and on the trade show floor.

Instructional methods include: Lecture format, with questions/answers/discussion throughout. 

How You Will Benefit:
By the end of the course, participants will have gained:

• How labeling, advertising, and promotion are related, and how they’re regulated
• How to ensure their labeling, advertising, and promotional materials are compliant
• When its safe to distribute off-label materials

Course Topics:

• What is Labeling?
• What is Advertising and Promotion?
• What are Claims?
  • Product claims
  • Promotional claims
  • Intended Use
• Indications for Use
• How does FDA regulate advertising and promotion? What role do FTC and FCC play?
• What is off-label use? Is it ever safe to distribute off-label material?
• How do we deal with this? (What CAN I say about my product?)
• How can we ensure that we are compliant (labeling review process)?

Who Should Attend:
Anyone who is involved in complaint handling and/or adverse event reporting: R&D, Mfg, RA/QA, sales/marketing personnel.

Cost:
Half-day class
Cost: $125 (includes class, all class materials, and snacks)

Instructor Bio: Sheila Ramerman, RAC
Sheila Ramerman is the founder and Principal at SJR Associates, a medical device regulatory affairs, quality systems, and clinical affairs consulting practice located in Eugene, OR.  Her consulting practice puts particular emphasis on assisting start-up stage companies implement their regulatory, quality, and clinical studies functions. Her clients range from start-up companies who are developing home-testing and near-patient testing devices, to well-established, global medical device manufacturers.  Prior to founding SJR Associates, Sheila was responsible for regulatory affairs, quality systems, and/or clinical studies at small or start-up medical device companies in the San Francisco Bay Area, working with a variety of medical device technologies. Sheila has been a moderator and presenter for medical device seminars and webcasts for the Regulatory Affairs Professional Society, and has been a member of RAPS since 1995. She is a guest lecturer in the UC-Santa Cruz Regulatory Affairs Certificate Program, and has been affiliated with OBA’s BioPro WorkForce Training program since early 2007. Sheila began her career as a Medical Laboratory Technician and Clinical Laboratory Scientist in community hospital laboratories, and has worked in the medical device industry since 1989. Sheila holds an AA degree in Clinical Laboratory Technology from Shoreline Community College in Seattle, WA; a BA in Health Services Administration from Saint Mary’s College in Moraga, CA; and she has been Regulatory Affairs Certified since 1998.