OPDP/APLB AND COMPLIANCE 101: A PRIMER

Tutorial name:
OPDP/APLB AND COMPLIANCE 101: A PRIMER

Day & Time:
February 26, 1:30PM - 5:00PM

Registration Fees
- Tutorial #1 Rate$405.00


Instructor(s):
Janet "Lucy" Rose, MBA
President
Lucy Rose and Associates, LLC, United States

Paul James Savidge, JD,MBA
Senior Vice President and Deputy General Counsel
Bristol-Myers Squibb Company, United States

Michele L. Sharp, PharmD
Senior Director, Global Regulatory Affairs - US
Eli Lilly and Company, United States

Description:

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!

To see more information on the Marketing Pharmaceuticals 2014 Workshop click here!



EventCredit TypeMax CreditsCEU
OPDP/APLB AND COMPLIANCE 101: A PRIMERACPE
IACET
3.25
3.25
0.325
0.300


Learning Objective(s):

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


Target Audience:
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!

© 2014