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AGENDA: PRECONFERENCE SESSIONS
Wednesday March 26, 2008
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1:00 - 5:00 p.m. |
Preconference I: Truth-Telling: Where Do We Go Now on Medical Imaging?
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Session Cancelled
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1:00 - 5:00 p.m. |
Preconference II: What To Do When the Subpoena Arrives: What You Should Know about Handling a Criminal Investigation
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You never expected this to hit you-but there it is. From this point on, everything will be different. What do you do? What do you avoid? This session will draw upon the knowledge and real-world experience of federal and company officials who have handled criminal investigations. Among the topics to be addressed:
- Why no company is immune from investigation and prosecution under the FD&C Act or fraud and abuse statutes.
- How prosecutors learn what happens and who is responsible in companies.
- How the government thinks companies can effectively respond to investigations.
- How to minimize the business disruption caused by an investigation.
- Which documents you must provide-and which you should object to providing-when responding to a subpoena.
- How to establish a compliance program that minimizes the likelihood of whistleblowers.
- Why a government investigation may lead to other actions (state AGs, FDA, Congress, SEC, products liability, employment).
- What documents should no company be without?
Speakers
- John Bentivoglio, Esq., Partner, King & Spalding LLP, Washington, DC
- Michael Harrington, Esq., Deputy General Counsel, Eli Lilly and Company, Indianapolis, IN
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
- Ioana Petrou, Esq., Assistant U.S. Attorney, United States Attorney's Office, Northern District of California, San Francisco, CA
- Douglas S. Strang, Esq., Partner, PricewaterhouseCoopers LLP, Philadelphia, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
- Anne K. Walsh, Associate Chief Counsel for Enforcement, Food and Drug Administration, Rockville, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
- Co chair: Jennifer Bragg, Esq., Partner, King & Spalding LLP, Former Assistant Chief Counsel for Enforcement, Food and Drug Administration, Washington, DC
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1:00 - 5:00 p.m. |
Preconference III: Writing for Risk Avoidance: How Gobbledygook and Bad Grammar Can Land You in Court-and How to Avoid It
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Remember the famous line from cop shows: "What you say can and will be used against you..."? Unfortunately, that warning holds true for what you write about your device-such as how it can be used, what it can do, and what it can't do. "How you say it" can become central to risk of lawsuits, compliance actions, and regulatory hassles. This session will draw together experts on risk exposure, labeling, product liability and, of course, clear writing to offer tips and techniques. Through a series of short presentations, Q&A, and roundtable discussions, our experts will address some key questions:
- How can you communicate in a way that will reduce your risk but also promote your product effectively?
- What can companies do immediately to reduce their risk?
- What are the biggest danger areas?
- What are the "seven dirty words" of risk exposure?
Speakers
- Sara E. Dyson, Esq., Staff Attorney, Medmarc Insurance Group, Chantilly, VA
- Tom Maeder, Executive Director, Medical Technology Learning Institute, AdvaMed, Washington, DC
- Rosemary Weghorst, Manager, National Life Sciences Practice, Huron Consulting Group, Chicago, IL
- Co chair: Nancy Singer, President, Compliance-Alliance, Former Special Counsel, AdvaMed, Washington DC
Permission to post not granted
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5:15 p.m. |
Reception, Harvard Faculty Club, Sponsored by
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