Short Course* Registration: 12:30PM-5:00PM
If you are new, or relatively new, to the preparation or review of advertising and/or promotional materials, this primer is for you! 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.
Dwight Bowen, Jr.
Senior Lead (Director), US Advertising and Promotion Regulatory Affairs
Jess Amchin, MD, JD
Jess Amchin Consulting, LLC
*Short Courses are not included in the conference registration and require a separate fee.
At the conclusion of this primer, participants should be able to:
- Discuss the current regulatory/compliance environment pertaining to prescription drugs, biologics, and medical devices as relevant to the DIA program content
- Describe the FDA advertising and promotional requirements, including such topics as (as relevant to the final program content): 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