CAMBRIDGE, MA USA -- PHARMA UPDATE NEWS SERVICE(TM) -- FEBRUARY 9, 2006: The First Annual Medical Device Regulatory and Compliance Congress (Device Congress), www.DeviceCongress.com, held on the campus of Harvard University March 29 - 31, 2006, will feature key regulatory issues for medical device manufacturers in 2006.

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."

CONGRESS PRECONFERENCE SESSIONS:

• Managing Risk By Getting to the Root Cause for Effective Corrective and Preventive Action (CAPA)
• How to Explain Device Reimbursement to Your CEO

CONGRESS KEYNOTE SESSION:

• Policies Initiatives at FDA by Scott Gottlieb, FDA’s Commissioner’s Office
• Enforcement initiatives at CDRH by Tim Ulatowski, CDRH’s Office of Compliance
• The future direction of CMS by Carol Kelly, Director of Office of Policy, CMS
• Recent prosecutions under the fraud and abuse statutes by Jim Sheehan, Assistant US Attorney

CONGRESS TRACKS:

• Quality: Best Practices in Using Metrics to Measure and Improve Quality
• Quality: Best Practices in Using Risk Management to Improve Your Quality System
• Reimbursement - Best Practices in Medicare Coverage, Coding, and Payment
• Off-Label Promotion: Managing Risk in Off- Label Promotion When Promoting New Products
• Fraud and Abuse Issues for Medical Device Manufacturers

QUALITY ISSUES ADDRESSED:

• Best practices in using a balanced scorecard
• How to measure the cost of poor quality
• Best practices in communicating product and compliance risks to top management
• Best practices in integrating risk management and design control, CAPA, and complaints
• How to use risk management to defend product liability actions

FRAUD AND ABUSE AND OFF LABEL ISSUES ADDRESSED:

• Recent medical device prosecutions
• The top ten sales and marketing risk areas
• New Report from PricewaterhouseCoopers on specific practices of medical device firms in complying with the AdvaMed Code of Conduct
• Model corporate compliance programs
• How firms are dealing with FDA’s policies on off label promotion
• Examples of recent warning letters on off label promotion

REIMBURSEMENT ISSUES ADDRESSED:

• The key dates/events when putting together a reimbursement strategy
• How to collect data for FDA and CMS without wasted effort
• The new model for evidence development
• How real is CMS's "pay for performance" and It feedback loop on post marketing performance of technology
• How does CMS technology break down if the face of the new technology

SPONSORED BY:

GOLD GRANTORS:	SILVER GRANTORS

CONGRESS EXHIBIT & SPONSORSHIP INFORMATION:

For sponsorship and exhibit information contact Joni Lipson, Exhibit Manager, 215-599-6626 phone, 215-545-8107 fax, or at joni.lipson@rmpinc.com.

REGISTRATION INFORMATION:

Register online at www.devicecongress.com/registration.html, call 800-684-4549, email: registration@hcconferences.com.

Device Congress Office
7790 Barberry Ave.
Yucca Valley CA USA 92284