"FDA and the pharma/biotech industry are being compelled by Congress, healthcare payors and patients to be more transparent with respect to the conduct and outcomes of clinical trials, including through the new clinical trial registry requirements of the Food and Drug Administration
Amendments Act of 2007, changes in CMS policies on payment for clinical trial healthcare services and increased scrutiny of where and how clinical trials are conducted. This session will discuss how biopharmaceutical companies can identify potential risk areas and legal and regulatory approaches to mitigate these risks."

Objective1: "Discuss the new and enhanced legal and regulatory obligations around clinical trials from FDA , CMS and state. authorities."

Objective2: Discuss strategies to identify risks from these enhanced legal and regulatory obligations.

Objective3: Discuss strategies to mitigate these risks both internally and externally.