Tuesday, July 27, 2010

Conducting Internal Investigations at Medical Device Companies

Your colleagues may be committing crimes right now, even if they don't mean to. But whether it is ignorance, negligence, or intent that motivates them, it is your job to find them

And there is urgency in what you do: Federal laws affecting company compliance programs are changing constantly. DoJ is increasing its scrutiny of device makers on off-label promotion, Anti-Kickback, False Claims, Foreign Corrupt Practices, and other fraud matters—and is punishing more severely those found to be breaking the rules.

Finding these violations in your company, and responding to them properly, is a difficult job—so be sure you're doing it right. Dulce Foster has conducted numerous investigations for medical device companies facing these very issues. In this 90-minute webinar, she will discuss the changing laws, and provide real-world insight on investigating and preventing fraud at your company, and when you should consider reporting it to those who, by law, must be informed.

After this program, you will know:

The changes that are coming in November to the U.S. Sentencing Guidelines on Effective Compliance programs, and how to change your reporting and monitoring programs to reduce risk of prosecution and punishment
The laws for which DoJ has especially focused its interest on medical device companies
What kinds of things might trigger an internal compliance investigation?
The first thing you should always do when you receive an allegation or evidence of fraud
4 "must-dos" and 5 "must-don'ts" in any internal investigation
When you should interview the alleged bad actor, and how to manage the interview
It appears that no laws were broken—can you close the file and be done?
When to call the government—and which government agencies to call
An executive's bad actions do not mean "game over"—here's how to get credit from DoJ when finding misconduct at high levels of your company

Dulce will also answer your team's questions in the Q&A session.

Who should attend...

Regulatory affairs and compliance staff
General and corporate counsel
Executive management
Risk management specialists

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.

SPEAKERS

Dulce Foster
Shareholder
Fredrikson & Byron

Dulce Foster is a shareholder in Fredrikson & Byron's Corporate Governance & Investigations Group, and Chairs the Internal Investigations Group. Her practice includes guiding medical device companies and other businesses through internal regulatory and compliance investigations, from the preliminary investigation stages through any resulting criminal or civil litigation. She has helped clients investigate potential illegal business practices, evaluate the risks and benefits of voluntary disclosures to the government, and develop prospective and remedial compliance measures. She has also assisted clients victimized by employee fraud and theft investigate and develop potential civil claims and complaints to prosecuting authorities.

Dulce's practice also includes criminal and civil litigation in the areas of financial fraud, healthcare fraud, FCPA, trade secrets theft, election fraud, illegal immigration, environmental crimes and False Claims Act defense. Dulce earned her J.D. from the University of Minnesota Law School.

Webinar Details

DATE: Tuesday, July 27, 2010
TIME: 1:00 PM ET • 11:00 AM MT • 10:00 AM PT
DURATION: 90 Minutes

Benefits

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 on which you'll be taken through the presenters' slides as they speak to them.
An interactive Q&A round with speakers by phone and electronic submission.
The insight you've come to expect and respect from Elsevier Business Intelligence and our guest speakers.

What are the unique benefits of a webinar?

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

SUPPORTING PUBLICATIONS

REGISTRATION

Buy the recording/transcript: Click here for just the recorded webinar with the complete transcript, $349
Register by email: custcare@elsevier.com
Register by phone: 1 (800) 332-2181 (U.S.) / +1 (908) 547-2159 (non- U.S.)

Webinar Cancellation Policy: No refunds or credits will be given one week prior to the scheduled webinar, or after the webinar presentation materials and access instructions have been sent to participants. In lieu of cancellation, you may substitute another delegate from your company as a replacement.