"Once a predominantly academic pursuit, clinical trials and sponsored research are now part of a growing business in which private companies, and in particular pharmaceutical companies, play a major role. As recent cases, investigations and developments reflect, the federal government is scrutinizing the clinical trial arena more closely. While past enforcement efforts have focused on clinical trials as potential vehicles for off-label promotion or improper inducements, the federal government and whistleblowers are now exploring new areas of potential exposure. Any company or individual involved in clinical trials and sponsored research would benefit from learning about this heightened oversight."

Objective1:Educate participants regarding key compliance issues in conducting clinical trials and sponsored research.

Objective2:Highlight and discuss emerging areas of potential exposure for researchers, physicians, academic medical centers and pharmaceutical companies in the clinical trial context.

Objective3:"Provide case study examples where clinical trials and sponsored research have become the focus of government enforcement attention."