Credible research studies can be a very effective means of informing providers about the efficacy of off-label use of devices, which makes FDA’s January 2009 guidance concerning procedures for dissemination of scientific literature about off-label use of devices significant for manufacturers. Under the guidance, FDA permits device companies to disseminate articles to doctors if that research is peer-reviewed and published in a journal with an expert editorial board. This webinar will give manufacturers the knowledge they need to capitalize on recent trends in regulatory action, while also avoiding the still substantial risks from government scrutiny into potentially improper off-label promotion of devices.

During this comprehensive 90-minute webinar, participants will ...

• Gain insights into FDA’s January 2009 guidance concerning procedures for dissemination of scientific literature on off-label uses and what that guidance means for everyday as well as strategic business operations
• Understand the continuing risks device manufacturers face from FDA and DOJ accusations of improper off-label promotion—risks that remain significant even under the new guidance
• Learn about the current status of laws regulating off-label promotion of devices and recent enforcement activity, especially in the context of everyday, operational activities
• Find out how manufacturers can best position themselves for any potential opportunities under this recent FDA guidance

 ... and much more.

For one low price, you and your entire team from one location can take part in this fast-paced, insightful webinar. Best of all, you’ll be able to connect personally with our panelists when we open up the phone lines for live Q&A.

The discussion will be delivered in a convenient audio conference format, and capped off with an interactive Q&A round.

So join us, in the convenience of your own office, for a thought-provoking analysis. Grab your team (or several teams), a conference room at your office, a phone and a computer with Web access (that last one's optional). No travel required.

Reserve your spot today! You can't afford to miss this insight.

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	RONALD H. LEVINE, former Criminal Division Chief at the U.S. Attorney’s Office in the Eastern District of Pennsylvania, is a partner in the Philadelphia office of Post & Schell, P.C., where he heads its national practice in white collar defense, internal investigations and corporate compliance.   Mr. Levine assists enterprises and individuals that are subject to government regulation or investigation, conducts internal corporate investigations of alleged misconduct, consults on compliance plans, and defends enterprises, directors, officers and other professionals accused of misconduct at criminal or civil trials and on appeal.   Mr. Levine has taught or spoken on white collar crime, criminal procedure or trial advocacy at Temple University School of Law, the University of Pennsylvania Law School, Villanova University School of Law, Brown University and the Wharton School, and at programs hosted by the ABA White Collar Crime Section, AHLA-HCCA Fraud & Compliance Forum, and the Institute on Federal Program Fraud.   He sits on the editorial advisory board of the Business Crimes Bulletin, has consulted for the National Institute of Justice, is Vice-Chair of the Federal Bar Association Criminal Law Committee (Philadelphia), was Vice-Chairman of the American Health Lawyers Association Corporate Governance Task Force, and has served on the Leadership Committee of DRI’s Corporate Integrity and White Collar Crime Committee. Mr. Levine also sits on the Board of Directors of the Committee of Seventy, a good government “watchdog” organization.   Mr. Levine is a graduate of the University of Pennsylvania Wharton School, Oxford University and Harvard Law School.
	JOHN N. JOSEPH, former criminal prosecutor and Deputy Chief of the Civil Division at the U.S. Attorney’s Office in the Eastern District of Pennsylvania, is a partner in the Philadelphia-based law firm of Post & Schell, P.C., where he is part of its national practice in white collar defense, internal investigations and corporate compliance.   Mr. Joseph litigates complex corporate fraud and white collar cases, including “whistleblower” actions brought under the qui tam provisions of the False Claims Act; conducts internal corporate investigations of alleged misconduct, consults on compliance plans, and helps clients respond to government investigations; advises enterprises and individuals that are subject to government regulation on issues of compliance, corporate integrity agreements, and Sarbanes-Oxley requirements; and defends enterprises, directors, officers and other professionals accused of misconduct at criminal or civil trials and on appeal.   Mr. Joseph has taught or lectured on white collar crime, the False Claims Act and trial advocacy at The Department of Justice’s National Advocacy Center, and has served as faculty for the National Institute for Trial Advocacy. He has also written and spoken on issues of fraud and compliance at programs hosted by the, AHLA-HCCA Fraud & Compliance Forum and the Pennsylvania Bar Institute. Mr. Joseph also serves on the AHLA’s Fraud and Abuse Enforcement Panel.   Mr. Joseph is a graduate of the University of Pennsylvania and the University of Pennsylvania Law School.

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  What does registration get me?

• One (1) phone line, for you alone, or around which to gather your team(s). Toll-free in the U.S. only.
• One (1) password to a website where you'll be taken through the presenters' slides as they speak.
• An interactive Q&A round with speakers by phone and electronic submission
• Online access to the audio and slides of the entire event if you can't attend the webinar live, and still want to hear the content.
• The insight you've come to expect and respect from Windhover Webinars and our guest speakers.

• Convenience – and lower cost. Your entire team can listen in one room. No travel required!
• A team approach. You've often wanted to have everyone on your team getting the same knowledge and insight you derive from physical conferences. Now you can.
• Interactivity. You're remote, but not removed. Our webinars let you ask the important, burning, controversial questions of our speakers that you'd be able to pose at a physical conference.
• Flexibility. Want to be able to review what you learn? No problem ... just register for the live webinar PLUS a digital copy of the entire event to listen to at your convenience. Interested in the topic but have a scheduling conflict? Don't worry — the recording is available for purchase at any time!
  
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