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Device Congress Agenda: Day II
Thursday, March 30, 2006
Annenberg Hall

7:30 a.m.

Registration - Annenberg Hall

MORNING TRACKS
Morning Track A - Quality: Best Practices in Using Metrics to Measure and Improve Quality - Annenberg Hall
Kathleen Lundberg, Chief Compliance Officer, Guidant Corporation, St. Paul, MN (Co chair)
8:30 a.m. Best Practices for Successfully Using a Balanced Scorecard
What is a Balanced Scorecard? What are six keys to its successful utilization? Where do companies experience problems?

Steve Ojala, Ph.D.
Global Director
Eli Lilly
Indianapolis, IN
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
9:15 a.m. Best Practices in Measuring the Cost of Poor Quality
What factors go into calculating the cost of poor quality? How can medical device officials use the data to lobby for more resources for preventive actions?

Daniel Olivier
President, Certified Software Solutions, Inc.
Expert Witness for FDA
San Diego, CA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Javad Seyedzadeh
Senior Vice President, QA/RA
Bayer Healthcare
Tarrytown, NY
10:00 a.m. Break
10:30 a.m. Best Practices for Conducting Management Reviews
What are the requirements for compliance? What are companies doing to fulfill their regulatory obligations?

Nancy Singer, Compliance-Alliance, LLC
Former Special Counsel AdvaMed
Arlington, VA

Fran Akelewicz, Practical Solution
Founder and President, Practical Solution
Yardley, PA
11:15 a.m. Best Practices in Communicating Business, Product and Compliance Risks to Top Management
What are some effective techniques to get the attention of top management? How do you distill the report into language that top management will pay attention to? What are some effective methods of communication?

Javad Seyedzadeh
Senior Vice President, QA/RA
Bayer Healthcare
Tarrytown, NY
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Noon Lunch at the Harvard Faculty Club
Morning Track B - Reimbursement - Best Practices in Medicare Coverage, Coding, and Payment - Lowell Hall
Ron Geigle, Partner, Polidais LLC, Arlington, VA (Co chair)
Susan Morris, Vice President, Reimbursement Policy and Compliance, Kinetic Concepts, Inc., San Antonio, TX (Co chair)
8:30 a.m. Timing is Everything: Best Practices in Timing Coverage, Coding, and Payment
How do the timing of coverage, coding, and payment events, annual updates, and application due dates affect your strategy and planning? Where's the best place to start?

Stephanie Mensh
Former Vice President
Payment and Policy, AdvaMed
Falls Church, VA
Presentation Material (Acrobat)
Handout Material (Acrobat)

Michael J. Ruggiero, Esq.
Of Counsel, King & Spalding, LLP
Washington, DC
9:00 a.m. "Doing Double-Duty:" Collecting Data for FDA and CMS in the Same Study
How do the demands from FDA and CMS for clinical trial data compare? How can companies collect data for both agencies in the same clinical trials?

Barbara Calvert
Director, Medical Products Reimbursement
Abbott Diagnostics
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Donald P. Conway, MD, MBA
Director, Healthcare Initiatives
Tuck School of Business at Dartmouth
Assistant Professor, Dartmouth Medical School
Hanover, NH
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Gregory de Lissovoy, Ph.D.
Vice President and Senior Research Scientist, The MEDTAP Institute
United BioSource Corporation
Bethesda, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Robin Strongin
Partner, Polidais LLC
Arlington, VA
(Moderator)
10:00 a.m. Break
10:30 a.m. "E" is for Evidence: Innovative Strategies for Meeting Medicare Coverage Demands
What are Medicare's new models for "coverage with evidence development" and how are they working? How can device manufacturers benefit from registries, post-market monitoring, and other approaches?

M. Weston Chapman
Chairman and Chief Executive Officer
Medical Metrx Solutions
West Lebanon, NH
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Ron Milhorn
Former Senior Policy Analyst with Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Managing Partner, Ron Milhorn, LLC
Finksburg, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Handout Material (Acrobat)
Handout Material (Microsoft Word)

Susan Morris
Vice President, Reimbursement Policy and Compliance
Kinetic Concepts, Inc.
San Antonio, TX
(Moderator)
Noon Lunch at the Harvard Faculty Club
Morning Track C - Off-Label Promotion: Managing Risk in Off- Label Promotion When Promoting New Products - Science Center A
Robert J. Klepinski, Esq., Of Counsel, Fredrikson & Byron , Former Senior Regulatory Counsel, Medtronic, Minneapolis, MN (Co chair)
8:30 a.m. Balancing the Public's Right to Know With the Government's Obligation to Protect Patients
What are the First Amendment concerns with the government effort to regulate advertising and promotion of medical devices? What is the proper role of the FDA and the Department of Justice?

Richard A. Samp, Esq.
Chief Counsel, Washington Legal Foundation
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
9:15 a.m. Setting Promotional Strategy and Tactics After the Rebirth of the First Amendment
How do you assimilate the recent First Amendment court cases and FDA policy? What is FDA doing in reaction to the new world and how does it affect your submissions and ad campaigns?

Robert J. Klepinski, Esq.
Of Counsel, Fredrikson & Byron
Former Senior Regulatory Counsel, Medtronic
Minneapolis, MN
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
10:00 a.m. Break
10:30 a.m. How to Implement a System For Review of Product Promotion
What are key elements of a product review system? How do you get employees to adhere to the requirements?

Judith E. O'Grady, RN, MSN
Senior Vice President, Regulatory, Quality and Clinical Affairs
Integra Lifesciences
Plainsboro, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
11:15 a.m. Examples of FDA's Recent Untitled Letters for Off Label Promotion
What are some recent letters? How should companies respond to FDA when they get an untitled letter?

Stephen Terman, Esq.
Partner Olsson Frank and Weeda
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Noon Lunch at the Harvard Faculty Club

AFTERNOON TRACKS
Afternoon Track D - Quality: Best Practices in Using Risk Management to Improve Your Quality System - Annenberg Hall
Richard DeRisio, Vice President, Quality Assurance and Regulatory Affairs, Kinetic Concepts, Inc., San Antonio, TX (Co chair)
1:30 p.m. Best Practices for the Integration of Risk Management and Design Control
How to employ risk management when developing features for safety and profitability? How to employ risk management for efficient design transfer?

Frances Akelewicz
Founder and President, Practical Solution, LLC
Yardley, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
2:15 p.m. Best Practices for the Integration of Risk Management and Corrective and Preventive Action
How to use risk management to prioritize corrective and preventive actions? How to use risk management as a predictive indicator?

Norman L. Collazo
Worldwide Director, QA
Cordis Corporation
Miami Lakes, FL
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
2:45 p.m. Break
3:15 p.m. Best Practices for Integrating Risk Management in Complaint Handling
How can you use complaints to improve quality? How can the tools you use to monitor complaints help you evaluate potential risks from your product? When does a complaint mandate that you take corrective action?

Richard DeRisio
Vice President, Quality Assurance and Regulatory Affairs
Kinetic Concepts, Inc.
San Antonio, TX
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
4:00 p.m. Extracting Maximum Value from your Quality System and Processes through Integrated Operations
How are the industry trends driving us toward transformational change? How can integrated operations assist with improving customer service, quality, compliance and risk management?

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

Michael Mentesana
Director, Pharmaceutical Business Operations
PricewaterhouseCoopers LLP
New York, NY
Presentation Material (Acrobat)
4:45 p.m. Best Practices for Using Risk Management to Defend Product Liability Actions
When do you educate the staff on risk management principles? How do you document your risk management decisions?

Rita C. McIntyre, RN, RAC
Manager, Customer Quality
Ortho Clinical Diagnostics
Raritan, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
5:30 p.m. Adjournment and Networking Reception
Afternoon Track E - Reimbursement - Lowell Hall
Robin Strongin, Partner, Polidais, Arlington, VA (Co chair)
1:30 p.m. Medicare's IT Paradigm: How Real, How Soon?
How real is CMS Director Dr. Mark McClellan's vision of "pay for performance," and an IT feedback loop on the post-marketing performance of technology? What systems currently exist and how do they function? How can device manufacturers participate and benefit?

Sharon Canner
Vice President, Government Affairs
eHealth Initiative
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Rose Marie Sweeney
Vice President, Socioeconomic Affairs and Policy Analysis
American Academy of Family Physicians
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
2:30 p.m. Case Study: Roundtable Discussion on Challenges of Trials, Evidence, and IT
How can device manufacturers successfully manage the intricately intertwined issues of planning clinical trials, coverage with evidence development, and advances in health information technology? How can these efforts result in reasonable payment under Medicare?

Donald W. Moran
Founder and President, The Moran Company
Arlintgton, VA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

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

Ron Geigle
Partner, Polidais LLC
Arlington, VA
(Moderator)
3:30 p.m. Break
4:00 p.m. New Products, Old Payment Systems
How do CMS's traditional payment systems break down in the face of new technology, such as computer assisted devices, combination products, and telehealth? What are the best practices in making payment systems work for new technology?

Jeff Farkas
Senior Director, Health Policy and Payment
Medtronic, Inc.
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

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
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Parashar Patel
Vice President For Reimbursement and Outcome Planning
Boston Scientific
Natick, MA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Greg White
Director of Health Policy
Johnson and Johnson
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

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

(Moderator)
5:30 p.m. Adjournment and Networking Reception
Afternoon Track F - Fraud and Abuse - Science Center A
Peter Claude, Partner, PricewaterhouseCoopers LLP, Florham Park, NJ (Co chair)
1:30 p.m. Medical Device Prosecutions: Parallels Between the Bard Prosecution in 1990 and the Serono Prosecution in 2005
What mistakes did the companies make? Steps firms can take to avoid those mistakes in the future.

Michael Loucks, Esq.
First Assistant US Attorney
US Attorney's Office
Boston, MA
2:30 p.m. The Top Ten Sales and Marketing Risk Areas
What are they now? What are they expected to be? What can you do to reduce your risk?

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

John Bentivoglio, Esq.
Partner, King and Spalding
Former Special Counsel for Healthcare Fraud
Chief Privacy Officer, United States Department of Justice
Washington, DC
3:15 p.m. Break
3:30 p.m. Report on Industry Compliance Better Practices
PricewaterhouseCoopers will report on the results of its analysis of industry better practices around sales and marketing compliance requirements of the AdvaMed Code and selected safety reporting practices.

Peter Claude
Partner, PricewaterhouseCoopers LLP
Florham Park, NJ

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

John Bentivoglio, Esq.
Partner, King and Spalding
Former Special Counsel for Healthcare Fraud
Chief Privacy Officer, United States Department of Justice
Washington, DC
4:15 p.m. Model Programs: An Overview of Leading Medical Device Compliance Programs
What are the key elements? How do you get buy-in?

Catherine A. Sazdanoff
Divisional VP, Ethics & Compliance
Abbott Laboratories
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
5:00 p.m. Ask the Experts: Audience is invited to pose questions to leading device compliance professionals
5:30 p.m. Adjournment and Networking Reception



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