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AGENDA: PRECONFERENCE
Wednesday, March 28, 2007

7:30 a.m.

Conference Registration

8:30 a.m.

Preconference I: Implementing International Codes of Conduct

Why are compliance controls necessary when selling internationally? What countries in the eastern and western hemisphere have fraud and abuse laws, and what are their major provisions? What actions have been taken by international government authorities to enforce the fraud and abuse laws? How can medical device firms operate their multiple applicable overseas codes? How can overseas device companies ensure a coordinated approach to compliance?

Attendees of this preconference session will receive a detailed compendium of international guidance developed by Huron Consulting Group and King & Spalding, LLP.

  • John Bentivoglio, Esq., Partner, King & Spalding LLP, Former Special Counsel for Healthcare, Fraud and Chief Privacy Officer, United States Department of Justice, Washington, DC
  • William Fitzgerald, Esq., Director of Global Compliance, Alcon Laboratories, Inc., Fort Worth, TX
  • Daniel Garen, Senior Counsel, Siemens Medical Solutions Diagnostics, Tarrytown, NY
  • Donna Hill, Esq., Assistant General Counsel, SCA Americas, Philadelphia, PA
  • William J. Hrubes, Corporate Compliance Officer, Gambro, Inc, Lakewood, CO
  • Keisuke Kaye Suzuki, Former Executive Vice President, Chief Regulatory, and Quality Officer and Director, Guidant Japan KK, Yokohama, Japan
    Presentation Material (Acrobat)
    Presentation Material (Powerpoint)
  • Rosemary Weghorst, Manager, Huron Consulting Group, Chicago, IL
  • Christopher White, Esq., Executive Vice President, General Counsel and Secretary, AdvaMed, Washington, DC
  • Scott Willoughby, Managing Director, Huron Consulting Group, Former Associate General Counsel, PhRMA, Washington, DC
8:30 a.m.

Preconference II: Understanding Private Payers and Maximizing Private Payer Reimbursement Strategies
How do private payers make reimbursement decisions affecting medical devices? How should medical device companies factor private payers into their reimbursement strategy? Do private payers lead or follow Medicare? What kind of clinical data, evidence, and supporting information do private payers want from device companies? What is the best way to access private payers? What are case examples of successful reimbursement strategies for medical devices?

8:30 a.m.

Preconference III: After the Inspection: Managing FDA Enforcement Actions
What information should firms include in their response to 483 observations to prevent them from receiving a warning letter? How should firms respond to a warning letter to avoid further enforcement action? When and how to meet with the FDA? Are you ready for a recall?

11:45 a.m. Adjournment of Preconference Symposia/Lunch on Your Own



AGENDA: DAY ONE
Opening General Session
Wednesday, March 28, 2007

1:00 p.m.

Welcome and Opening Remarks

John Bentivoglio, Esq.
Partner, King & Spalding
Former Special Counsel for Healthcare Fraud and Chief Privacy Officer
United States Department of Justice
Washington, DC
(Co chair)

Nancy Singer, Esq.
President, Compliance-Alliance
Former Special Counsel, AdvaMed
Founder, AdvaMed Medical Technology Learning Institute
Arlington, VA
(Co chair)

1:05 p.m.

Advocating for Reasonable Regulation
What does the medical device industry need to accomplish in 2007 - 2008? If successful, how will this affect individual device manufacturers? How can AdvaMed help companies accomplish their goals?

Steve Ubl
President and Chief Executive Officer, AdvaMed
Washington, DC

1:40 p.m.

CDRH's Regulatory Agenda for 2007 - 2008
What are CDRH's biggest challenges in accomplishing its mission to protect the public health and provide timely access to safe and effective products? What is their enforcement agenda for 2007- 2008? How can medical device firms influence the process? How can professionals in medical device firms challenge agency decisions?

Tim Ulatowski
Director, Office of Compliance
Center for Devices and Radiological Health
Food and Drug Administration
Rockville, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

2:20 p.m.

Break

2:40 p.m.

International Harmonization: Reality or Fantasy
What are the current obstacles to "real harmonization"? Have the regulators who participate in GHTF changed their guidance and regulations in significant ways? If not, why not? Has industry come to the table and participated in a way to move this process forward? If not, how can this be overcome?

Michael Gropp
Vice President, Global Regulatory Strategy
Medtronic, Inc.
Minneapolis, MN
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

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
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

3:30 p.m.

CMS Priorities for 2007-2008: What Device Innovators Should Know about Medicare Reimbursement
How will federal priorities affect reimbursement? What policy requirements are driving the reimbursement program in 2007 - 2008? How will the Administration's transparency, price and quality initiatives affect the medical technology industry?

Carol Kelly
Director, Office of Policy
Centers for Medicare & Medicaid Services, DHHS
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

4:10 p.m.

Highlights of the Benchmarking survey on Complying with the AdvaMed Code

Peter Claude
Partner, PricewaterhouseCoopers LLC
Florham Park, NJ

4:25 p.m.

Introduction of International Medical Device Code Compendium

Scott Willoughby
Managing Director, Huron Consulting Group
Washington, DC

4:40 p.m.

Fraud and Abuse: Lessons Learned From Government Prosecutions
What actions have been taken for violation of the fraud and abuse laws? How can companies use this information to ensure they have implemented appropriate compliance practices?

Michael Loucks, Esq.
First Assistant US Attorney
US Attorney's Office
Boston, MA

5:30 p.m.

Adjournment

5:30 p.m.

Reception - Annenberg Hall

7:00 p.m.

PricewaterhouseCoopers Device Congress Banquet
Harvard Faculty Club

(Separate registration required)




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