This session will provide a broad-based review of the various laws and regulations that impact clinical trials. This discussion will focus primarily on issues including the Foreign Corrupt Practices Act, False Claims Act, anti-kickback laws, determination of fair market value, and HIPAA. There will also be a discussion on the non-FDA governmental organizations that may get involved in clinical trial compliance including HHS and the US Attorney's Office.

Learning Objectives:
Identify organizations besides the FDA that may be reviewing your clinical trials
Discuss what non FDA organizations may be looking for during the post IND- pre-commercial phase
Describe the implications of not having a legally compliant clinical trial.