OPDP/APLB and Compliance 101: A Primer
Feb 19 2013 1:30PM - Feb 19 2013 5:00PM | Grand Hyatt Washington at Washington Center
1000 H Street, NW,
Washington, DC 20001-4310
If you are new, or relatively new, to OPDP and/or advertising/promotional compliance, this tutorial is for you!! The leaders will provide a strong introductory foundation for anyone working in our new regulatory environment. Whether you are a regulatory, legal, medical, or marketing professional, the information will be interesting, practical and vital!
Who Should Attend
This program is designed for individuals involved in marketing, legal, regulatory, public affairs, and advertising in the pharmaceutical and biologics industries, plus their consultants and agencies. If you are relatively new to this area, please join our experienced experts to gain the important information you need to maximize your conference learning!
At the conclusion of this tutorial, participants should be able to:
- Discuss the current regulatory/compliance environment pertaining to prescription drugs, biologics and medical devices, both from an FDA and OIG/DOJ perspective
- Describe the FDA advertising and promotional requirements, including such topics as: claim support requirements, fair balance expectations, internet challenges, product booths at medical conventions, disease state programs, and public relations challenges.
Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.
Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.