Ropes & Gray is proud to sponsor the 2008 BIO International Convention in San Diego, CA. The convention serves to educate the public and policymakers about biotechnology, while fostering partnering meetings and other business development activities that keep the industry growing. The largest gathering of biotechnology leaders in the world, BIO 2008 is expected to attract more than 20,000 biotechnology experts, feature over 180 sessions, and over 2,200 exhibitors.
The following Ropes & Gray attorneys are scheduled speakers:
Alan Bennett, Partner
"Off-Label Dissemination: Legal, Regulatory and Policy Issues in Federal Criminal and Civil Cases"
Tuesday, June 17, 2008
1:30 - 3:00 PM
This session will summarize recent government enforcement and related civil actions in the off-label arena. We will discuss the legal theories supporting government prosecutions and civil claims in off-label cases, and identify when off-label dissemination is likely to trigger government scrutiny. Also highlighted will be the important patient health and public policy considerations implicated by criminal and civil off-label cases.
Joan McPhee, Partner
"Emerging Enforcement Trends: Clinical Trials and Sponsored Research"
Wednesday, June 18, 2008
8:15 - 9:45 AM
This session will educate participants regarding key compliance issues in conducting clinical trials and sponsored research. We will highlight and discuss emerging areas of potential exposure for researchers, physicians, academic medical centers and pharmaceutical companies in the clinical trial context. We'll also provide case study examples where clinical trials and sponsored research have become the focus of government enforcement attention.
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