Events
Speaking Engagement

Steering Clear of Civil and Criminal Liability When Conducting Clinical Trials

ACI's 13th National Forum on Fraud and Abuse in the Sale and Marketing of Drugs

New York, NY

Nicholas C. Harbist, partner at Blank Rome, will be speaking at the American Conference Institute's 13th Annual Forum on Fraud and Abuse in the Sale and Marketing of Drugs on March 21, 2013 at ONE UN New York in New York, NY.

Mr. Harbist will be speaking on a panel entitled, "Steering Clear of Civil and Criminal Liability When Conducting Clinical Trials," from 1:45 p.m. to 2:45 p.m. The panel will cover topics such as:

  • Pinpointing common clinical trials practices which may raise a red flag for enforcers, including:
    • Engaging in off-label promotions during a trial
    • Avoiding anti-kickback concerns with investigator initiated studies
    • Determining fair market value for the investigator's services
    • Misstatements of clinical trial data in a new drug application
    • Failing to report adverse events during a trial
  • Exploring prosecutorial tools to pursue False Claims Act liability for wrongful conduct in connection with a trial
  • Preparing for the certain prospect of increased monitoring and OIG oversight for clinical trials conducted globally
  • Factoring compliance into your clinical trial's design and factoring clinical trials into your compliance program's design

The forum will also offer a number of other sessions discussing identifying specific sales and marketing practices which may raise red flags, guarding proactively against impermissible off-label promotions, revamping compliance programs in light of recent False Claims Act (FCA) investigations into alleged GMP violations, minimizing global anti-bribery risks and Foreign Corrupt Practice Act (FCPA) violations when managing a global sales and marketing force and formulating legal and equitable defenses to counter a prosecution for individual liability and avoid the acts or omissions which may lead to a Park doctrine prosecution.

To learn more about the forum, please click here or visit www.americanconference.com.