Overview of Huron and the International Medical Device Compliance Code Compendium The Second Annual Medical Device Regulatory, Reimbursement and Compliance.

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Presentation transcript:

Overview of Huron and the International Medical Device Compliance Code Compendium The Second Annual Medical Device Regulatory, Reimbursement and Compliance Congress March 28, 2007 © Huron Consulting Services LLC. All rights reserved.

2 Serving the Industry Huron has a multi-disciplinary team of professionals with deep industry experience in sales & marketing, clinical & medical affairs, commercial contracting, and government price reporting. Our professionals have worked on a wide range of matters including compliance assessments, litigation support, valuation determinations, and operational consulting.  National practice of professionals with deep industry experience focused on supporting the pharmaceutical, biotechnology, and medical device industries in sales & marketing, clinical & medical affairs, commercial contracting, and government price reporting.  Each of our practice leaders have spent a significant portion of their professional careers either working for or providing services to the pharmaceutical, biotechnology, and medical device industries in various positions including: legal, sales & marketing, managed care, clinical affairs, and government contracts.  The team has assisted numerous clients with litigation and compliance matters involving the HHS OIG and the Department of Justice as a result of investigations and prosecution under the anti- kickback statue or the false claims act.  Our team has served as part of the Independent Review Organizations resulting from Corporate Integrity Agreements and Consent Decrees involving sales & marketing, government price reporting, clinical trials, and manufacturing. Multi-Disciplinary Team

3 The International Medical Device Compliance Code Compendium  Multi-Organizational Effort –Huron Consulting Group –Paul Silver: , –Rosemary Weghorst: , –Scott Willoughby: , –King & Spalding, LLP –John Bentivoglio: , –The Compliance Alliance –Nancy Singer: ,  With Special Thanks To –AdvaMed/Christopher White, Esq., EVP, General Counsel and Secretary, AdvaMed

4 The International Medical Device Compliance Code Compendium  Areas of Review –Member-Sponsored Product Training and Education –Supporting Third Party Educational Conferences –Sales and Promotional Meetings –Arrangements with Consultants –Gifts –Provisions of Reimbursements and Other Economic Information –Grants and Other Charitable Donations

5 The International Medical Device Compliance Code Compendium  Review of Self-Regulatory Codes –40+ countries included –Regional associations (e.g., Eucomed) –Full copies of codes –Comparison between countries –High level charts for a “bird’s eye” comparison between countries  Coming Soon –CD Rom –Web site link on Huron’s homepage:

6 The International Medical Device Compliance Code Compendium  To request additional copies, please contact: –Paul Silver — — –Rosemary Weghorst — –Scott Willoughby —