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The Second Annual Medical Device Regulatory, Reimbursement and Compliance Congress
Benchmarking Your Firm's Domestic and International Practices in Quality Systems, Reimbursement, Fraud and Abuse and Promotion

The Inn at Harvard and Harvard Square Hotel
March 28 - 30, 2007

SAVE THE FOLLOWING DATE
THIRD ANNUAL MEDICAL DEVICE REGULATORY, REIMBURSEMENT AND COMPLIANCE CONGRESS AT HARVARD
March 26 - 28, 2008

DEVICE CONGRESS MULTIMEDIA
Watch video of the 2007 Device Congress on the go. The Device Congress offers Podcasting of all general sessions on a 30gb Video iPOD™, a CD-ROM, or a Flash Drive. Concurrent breakout session audio and all related presentation materials are also included on each multimedia format.

Click here to order!

THE VENUES AT HARVARD

Classes Held: Harvard University's Annenberg Hall, Lowell Hall, Science Center and the Harvard Faculty Club
Congress Hotel: The Inn at Harvard

WELCOME MESSAGE FROM ARTHUR MILLER
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 Regulation, Reimbursement, and Compliance issues."


KEYNOTE SPEAKERS
Carol Kelly
Director, Office of Policy, Centers for Medicare & Medicaid Services, DHHS, Washington, DC
Larry Kessler, ScD
Chair, Global Harmonization Task Force, Director, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Food and Drug Administration, Rockville, MD
Michael Loucks, Esq.
First Assistant US Attorney, US Attorney's Office, Boston, MA

Jim Sheehan, Esq.
Associate United States Attorney, Eastern District of Pennsylvania, Philadelphia, PA
Steve Ubl
President and Chief Executive Officer, AdvaMed, Washington, DC
Tim Ulatowski
Director, Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD
Christopher L. White, Esq.
Executive Vice President, General Counsel, and Secretary, AdvaMed, Washington, DC

CONGRESS CO CHAIRS
Susan Alpert, Ph.D., MD
Senior Vice President and Chief Quality, Regulatory Officer, Medtronic, Former Director, Office of Device Evaluation, Food and Drug Administration, Minneapolis, MN
John T. Bentivoglio, Esq.
Partner, King & Spalding, Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, United States Department of Justice, Washington, DC
Jennifer Bragg, Esq.
Partner, King & Spalding, Former Assistant Chief Counsel for Enforcement, Food and Drug Administration, Washington, DC
Peter Claude
Partner, PricewaterhouseCoopers LLP, Florham Park, NJ
Richard DeRisio
Vice President, Quality Assurance and Regulatory Affairs, Kinetic Concepts, Inc., San Antonio, TX
Denise Dion
Senior Regulatory Consultant. EduQuest, Formerly with FDA's Office of Regulatory Affairs
Marc Farley
Executive Director of Health Care Compliance, Johnson & Johnson, Inc., New Brunswick, NJ
William T. Fitzgerald, Esq.
Vice President, Global Compliance, Alcon Laboratories, Inc., Fort Worth, TX
Patricia Garvey, PhD
Regulatory Affairs Consultant, Former Corporate Vice President, Regulatory, Quality and Clinical Affairs, Edwards Lifesciences, San Juan Capistrano, CA

David R. Jones
Director Quality Assurance, Regulatory Affairs Consumer Healthcare Solutions Phillips Medical Systems, Andover MA
Kenneth E. Imler, MBA, Six Sigma Black Belt
Senior Vice President, Regulatory Affairs and Quality Assurance, Arrow International, Author, Get it Right: A Guide to Strategic Quality Systems, Reading, PA
Cecilia Kimberlin, Ph.D.
Group Vice President of Quality Assurance, Regulatory, Compliance, and Medical, Medical Products Group, Abbott Laboratories, Abbott Park, IL
Stephanie Mensh
Vice President, Reimbursement Policy, StrokeSurvivor.com, Former Vice President, Payment and Policy, AdvaMed, Washington, DC
Robert H. O'Holla, MBA
Vice President of Regulatory Affairs, Medical Devices and Diagnostics Group, Johnson & Johnson, New Brunswick, NJ
Daniel P. Olivier
Certified Software Solutions, Inc., President, San Diego, CA
Paul J. Silver
Managing Director, Huron Consulting Group, Atlanta, GA
Nancy Singer, Esq.
President, Compliance-Alliance, Former Special Counsel, AdvaMed, Founder, AdvaMed Medical Technology Learning Institute, Arlington, VA
Christopher L. White, Esq.
Executive Vice President, General Counsel, and Secretary, AdvaMed, Washington, DC

FEATURED FACULTY
Megan Barry
Ethics and Compliance, Premier, Inc., Charlotte, NC

Edward Basile, Esq.
Partner, King & Spalding LLP, Washington, DC

Debbie Brandel
Principal, Preferred Health Strategies, Former Staff, Health Care Financing Administration (CMS), Rye Brook, NY

Martin Browning
President, EduQuest, Hyattstown, MD

Willie Bryant
FDA Recall Consultant, Stericycle Pharmaceutical Services, Indianapolis, IN

Jeff Bush
Director of Corporate Reimbursement, Becton Dickinson, Washington, DC

Eliana Silva de Moraes, PhD
President, Silva de Moraes Advogados, Sao Paulo, Brazil

Daniel Garen
Senior Counsel, Siemens Medical Solutions Diagnostics, Tarrytown, NY

Debjit Ghosh
Director, Huron Consulting Group, New York, NY

Barbara Grenell, PhD
President, Preferred Health Strategies, Rye Brook, NY

Michael Gropp
Vice President, Global Regulatory Strategy, Medtronic, Inc., Minneapolis, MN

Ames Gross
President, Pacific Bridge Medical, Washington, DC

Sharon Higgins
Executive Director, Irish Medical Devices Association, Dublin, Ireland

Donna Hill, Esq.
Assistant General Counsel, SCA Americas, Philadelphia, PA

William J. Hrubes
Corporate Compliance Officer, Gambro, Inc, Lakewood, CO

Sandy Kalter, Esq.
Senior FDA Counsel, Medtronic, Inc., Washington, DC

Bob Klepinski, Esq.
Attorney at Law, Fredrikson & Byron, Minneapolis, MN

John Lovett, Jr.
Principal, Preferred Health Strategies, Former Senior Official, Empire Blue Cross and Blue Shield, Rye Brook, NY

Tracy Mastro
Director, Huron Consulting Group, Washington, DC

Jeff Micklos
General Counsel, Federation of American Hospitals, Washington, DC

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

Laura O'Donnell
Chief Compliance Officer, Zimmer, Inc., Warsaw, IN

Parashar Patel
Vice President for Health Economics and Reimbursement, Boston Scientific, Natick, MA

Randel Richner
President, Neocure, Former Vice President for Government Affairs and Reimbursement and Outcomes Planning, Boston Scientific, Newton, MA

Michael Santalucia
Vice President, Regulatory Affairs and Global Scientific Affairs, Bausch & Lomb, Rochester, NY

Jeffrey Shapiro, Esq.
Partner, Hogan & Hartson LLP, Washington, DC

Keisuke Kaye Suzuki
Former Executive Vice President, Chief Regulatory, and Quality Officer and Director, Guidant Japan KK, Yokohama, Japan

John Taylor III
Division Vice President, Federal Government Affairs, Abbott Laboratories, Former Deputy Commissioner, Office of Regulatory Affairs, Food and Drug Administration, Washington, DC

Rene van Zande
President and Chief Executive Officer, Emergo Group, Austin, TX

Rosemary Weghorst
Manager, Huron Consulting Group, Chicago, IL

Scott Willoughby
Managing Director, Huron Consulting Group, Former Associate General Counsel, PhRMA, Washington, DC


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