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The Medical Device Regulatory and Compliance Congress
Benchmarking Your Firm's Practices in Risk Management, Quality Systems, Fraud and Abuse, and Reimbursement

March 29 - 31, 2006

Classes Held in Harvard University's Annenberg Hall, Lowell Hall, Science Center and the Harvard Faculty Club, Cambridge, MA


Annenberg Hall


Faculty Club

Congress Hotel: The Inn at Harvard
Cambridge, MA




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NOW AVAILABLE!
The 2006 Device Congress on CD-ROM

Classes Held in Harvard University's Annenberg Hall, Cambridge, MA

The The Device Congress CD-ROM set will include video of all faculty presentations, synchronized with the PowerPoint presentations, which can easily be viewed using your computer. You can instantly navigate to the presenter and the exact content you wish to view.

Get yours today for only $295!
Discounts available for purchase of multiple copies.

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and to order your copy today!

Arthur Miller, Esq.
Bruce Bromley Professor of Law
Harvard Law School
Cambridge, MA

"It is my pleasure to welcome attendees of the Medical Device Congress to the campus of Harvard University. I hope that you will take advantage of this unique experience to study key Medical Device Regulatory and Compliance issues."



Special Preconference Sessions:
  • Managing Risk By Getting to the Root Cause for Effective CAPA
  • How to Explain Device Reimbursement to Your CEO
Congress Tracks: Keynote Speakers:

John T. Bentivoglio, Esq.
Partner, King & Spalding, Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, United States Department of Justice, Washington, DC
Scott Gottlieb, MD
Deputy Commissioner for Medical and Scientific Affairs, Office of the Commissioner, Food and Drug Administration, Washington, DC
Carol Kelly
Director of the Office of Policy, Centers for Medicare and Medicaid Services, Washington, DC
Michael K. Loucks, Esq.
First Assistant U.S. Attorney, U.S. Attorney, District of Massachusetts, Boston, MA
Jim Sheehan, Esq.
Assistant US Attorney, United States Attorney's Office for the Eastern District of Pennsylvania, Philadelphia, PA
Nancy Singer, Esq.
President, Compliance-Alliance, Former Special Counsel, AdvaMed, Founder, AdvaMed Medical Technology Learning Institute, Arlington, VA
Stephen J. Ubl
President and Chief Executive Officer, AdvaMed, Washington, DC
Tim Ulatowski
Director of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, Washington, DC
Congress Co Chairs:

George M. Burditt, Esq.
Of Counsel, Drug and Device Law Group, Bell Boyd and Lloyd, Chicago, IL

Peter Claude
Partner, PricewaterhouseCoopers LLP, Florham Park, NJ

Richard DeRisio
Vice President, Quality Assurance and Regulatory Affairs, Kinetic Concepts, Inc., San Antonio, TX

Ron Geigle
Partner, Polidais LLC, Arlington, VA

Robert J. Klepinski, Esq.
Of Counsel, Fredrikson & Byron , Former Senior Regulatory Counsel, Medtronic, Minneapolis, MN

Kathleen Lundberg
Chief Compliance Officer, Guidant Corporation, St. Paul, MN

Aabed Meer
Co-President, Harvard College Health Policy Society, Managing Editor, Harvard Health Policy Review, Harvard University, Cambridge, MA

Stephanie Mensh
Former Vice President, Payment and Policy, AdvaMed, Falls Church, VA

Susan Morris
Vice President, Reimbursement Policy and Compliance, Kinetic Concepts, Inc., San Antonio, TX

Robin Strongin
Partner, Polidais, Arlington, VA

Featured Faculty:

Frances Akelewicz
Founder and President, Practical Solution, LLC, Yardley, PA

Paul E. Berger
Publisher, www.StrokeSurvivor.com, Merrifield, VA

Willie R. Bryant, Jr.
NNC Group, Former Senior Recall Officer, Food and Drug Administration, Middletown, MD

Barbara Calvert
Director, Medical Products Reimbursement, Abbott Diagnostics, Washington, DC

Sharon Canner
Vice President, Government Affairs, eHealth Initiative, Washington, DC Rosemarie Sweeney, Vice President, Socioeconomic Affairs and Policy Analysis, American Academy of Family Physicians, Shawnee Mission, KS

M. Weston Chapman
Chairman and Chief Executive Officer, Medical Metrx Solutions, West Lebanon, NH

Norman L. Collazo
Worldwide Director, QA, Cordis Corporation, Miami Lakes, FL

Donald P. Conway, MD, MBA
Director, Healthcare Initiatives, Tuck School of Business at Dartmouth, Assistant Professor, Dartmouth Medical School, Hanover, NH

Gregory de Lissovoy, Ph.D.
Vice President and Senior Research Scientist, The MEDTAP Institute, United BioSource Corporation, Bethesda, MD

Jeff Farkas
Senior Director, Health Policy and Payment, Medtronic, Inc., Washington, DC

William T. Fitzgerald, Esq.
Director, Global Compliance, Alcon Laboratories, Inc., Fort Worth, TX

Georgia Layloff
Consultant (Former FDA Investigator), Granite City, IL

Nan Matthews
President, The Matthews Group, Littleton, CO

Rita C. McIntyre, RN, RAC
Manager, Customer Quality, Ortho Clinical Diagnostics, Raritan, NJ

Aabed Meer
Co-President, Harvard College Health Policy Society, Managing Editor, Harvard Health Policy Review, Harvard University, Cambridge, MA

Stephanie Mensh
Former Vice President, Payment and Policy, AdvaMed, Falls Church, VA

Michael Mentesana
Director, Pharmaceutical Business Operations, PricewaterhouseCoopers LLP, New York, NY

Ron Milhorn
Former Senior Policy Analyst with Coverage and Analysis Group, Centers for Medicare and Medicaid Services, Managing Partner, Ron Milhorn, LLC, Finksburg, MD

Arthur Miller, Esq.
Bruce Bromley Professor of Law, Harvard Law School, Cambridge, MA

Donald W. Moran
Founder and President, The Moran Company, Arlington, VA

Susan Morris
Vice President, Reimbursement Policy and Compliance, Kinetic Concepts, Inc., San Antonio, TX

Judith E. O'Grady, RN, MSN
Senior Vice President, Regulatory, Quality and Clinical Affairs, Integra Lifesciences, Plainsboro, NJ

Steve Ojala, Ph.D.
Global Director, Eli Lilly, Indianapolis, IN

Daniel Olivier
President, Certified Software Solutions, Inc., Expert Witness for FDA, San Diego, CA

Parashar Patel
Vice President For Reimbursement and Outcome Planning, Boston Scientific, Natick, MA

Randel Richner
Vice President, Government Affairs and Reimbursement and Outcomes Planning, Boston Scientific, Natick, MA

Brian Riewerts
Partner, Pharmaceutical Advisory Services Group, PricewaterhouseCoopers LLP, Baltimore, MD

Noemi Romero-Kondos
Lead Process Manager, Global Complaint Management, Hospira, Lake Forest, IL

Michael J. Ruggiero, Esq.
King & Spalding, LLP, Washington, DC

Richard A. Samp, Esq.
Chief Counsel, Washington Legal Foundation, Washington, DC

Catherine A. Sazdanoff
Divisional VP, Ethics & Compliance, Abbott Laboratories

Javad Seyedzadeh
Senior Vice President, QA/RA, Bayer Healthcare, Tarrytown, NY

Stephen Terman, Esq.
Partner Olsson Frank and Weeda, Washington, DC

Mark Vare, RPh, RAC
Director Marketing & Business Development, Stericycle Pharmaceutical Services, Indianpolis, IN

Tom Weaver
Quality and Operations Improvement Consultant, Weaver Consulting, Former Vice President, Quality Management, Baxter Healthcare, Chicago, IL

Greg White
Director of Health Policy, Johnson and Johnson, Washington, DC



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