3D Tissue Models
8th National Forum on Reducing Legal Risks in the Sale and Marketing of Medical Devices
The Allerton Hotel
North Michigan Avenue
Chicago, IL

Schedule of Presentations:

Monday, November 17, 2008
07:20:00 Registration and Continental Breakfast
08:00:00 Co-Chairs’ Opening Remarks Tracy P Berns, Neal R Roach
08:05:00 The Enforcers Speak: Providing Clarity and Guidance on the DPAs and the Legality of Sale and Marketing Practices and Relationships Specific to the Device Industry Sean R McKenna, Ana M Martínez, Nicholas C Theodorou, Laura G Hoey, Jeremy M Sternberg, Virginia A Gibson, Linda A Wawzenski
10:20:00 Morning Coffee Break
10:45:00 Providing Information About Devices to Doctors, Disseminating Peer-Reviewed Studies of Off-Label Uses & Avoiding FCA/FFDCA Scrutiny of Off-Label Promotion Laurie A Clarke
11:45:00 Critically Reviewing Your Existing Arrangements With Physicians Christina F Rich, Neal R Roach
12:00:00 Networking Luncheon, Sponsored by Covington & Burling LLP Richard F Kingham
14:05:00 Spotlight on Consulting Arrangements: Designing Compliant Policies and Procedures — and then Managing the Process David A Hile, Brian J Leddin, Cynthia M Arndt
15:20:00 Afternoon Refreshment Break
15:30:00 Examining Ongoing Monitoring in the Industry and the Evolving Role of the Independent Corporate Monitor in Light of Enhanced Scrutiny David Samson
16:30:00 Device Companies Under Investigation: Seamlessly Responding to Government Inquiries and Negotiating and Implementing Corporate Integrity Agreements LYNN SHAPIRO SNYDER, Karen F Green, Teresa I Ford, Peter Henderson
16:45:00 Conference Adjourns
17:45:00 Networking Cocktail Reception Hosted by: FTI
Tuesday, November 18, 2008
07:30:00 Continental Breakfast
08:00:00 Co-Chairs’ Remarks
08:35:00 Reducing the Risk of FCPA Investigations and Violations Donald J Ridings, Daniel Garen, Lawrence T. Weiss, Michael C Theis
10:10:00 Factoring In Unique International Ethics Codes and Legal Requirements Grant H Castle
10:50:00 Morning Coffee Break
11:05:00 Examining the Appropriate Circumstances for Discounting, Bundling, and Price Concessions Kevin G McAnaney
12:00:00 Device Reimbursement: Overcoming the Current Coverage, Coding, and Payment Challenges Allison Shuren
12:00:00 CDRH/FDA Spotlight Address Bryan H Benesch
12:55:00 Networking Luncheon for Speakers and Delegates
14:00:00 The Current Fraud and Abuse Landscape on Pre- and Post-Market Device Human Subject Research Arrangements David M Ryan, Ralph F Hall
15:00:00 Afternoon Refreshment Break
15:05:00 TV, Radio, Print and “New Media”: Identifying Legal and Business Parameters for DTC Marketing of Medical Devices Cathy Garrison, Jeffrey K Shapiro, Tracy P Berns
16:25:00 Tracking State Legislative Initiatives and Harmonizing Inconsistent State Obligations Affecting the Sale and Marketing of Devices Robert S Salcido
17:25:00 Conference Ends
Wednesday, November 19, 2008
09:00:00 Implementing and Expanding Effective Monitoring and Auditing Controls as Part of Your Overall Compliance Program Brian Kelly, Karl H Buch, Teresa I. Ford
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