The Park Doctrine: Protect Yourself from Personal Criminal Charges Stemming From Your Company's Misconduct

Presented by Sheldon Bradshaw

Recorded On: Tuesday, July 27, 2010

Duration: 90 minutes

PURCHASE:

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CD and Transcript ($400.00)
On-Demand ($325.00)

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RECORDING HIGHLIGHTS:

Imprisonment. Criminal fines. Debarment. These are just a few of the consequences that individual corporate officers in FDA-regulated companies can face if their company engages in misconduct. These penalties can be imposed even when the corporate officers were uninvolved in, and/or unaware of, the misconduct.

The FDA is increasingly targeting individual corporate officers. According to a recent letter written by Commissioner Hamburg, the FDA will “increase the appropriate use of misdemeanor prosecutions…to hold responsible corporate officials accountable.”

How can you protect yourself from facing criminal penalties as a result of your company’s activities? In this 90-minute audio conference, former FDA Chief Counsel Sheldon Bradshaw will discuss what you must do to avoid personal criminal prosecutions.

Questions That Will Be Answered:

Why is the FDA targeting individual corporate officers?
Who is most at risk for being targeted by this doctrine?
How can you determine if you are at risk?
What steps should you take if you determine that you are at risk?
What proactive steps should you take to protect yourself in the future?

Attendees Who Will Benefit From This Audio Conference Include:

Corporate officers in FDA-regulated companies
Regulatory affairs professionals
General counsel
Corporate counsel

YOUR EXPERT(S):

Sheldon Bradshaw
Sheldon Bradshaw is a partner at Hunton & Williams LLP, where he co-chairs the firm's Food and Drug Practice Group. Mr. Bradshaw came to Hunton from the U.S. Food and Drug Administration (FDA), where he served as Chief Counsel. As Chief Counsel, Mr. Bradshaw was responsible for providing legal advice to the Secretary and Deputy Secretary of the U.S. Department of Health and Human Services and to the FDA's senior leadership - including the Commissioner, the Deputy Commissioners and the Directors of the various FDA Centers - on issues related to drugs, biologics, medical devices, food, animal feed and drugs, cosmetics, dietary supplements and other products regulated under the Federal Food, Drug and Cosmetic Act and the Public Health Service Act. In addition, he oversaw all FDA-related litigation and reviewed and approved every significant regulation and guidance document promulgated by the FDA and every significant warning letter issued by the FDA. Prior to his service at the FDA, Mr. Bradshaw held several senior positions at the U.S. Department of Justice.