West Coast Medical Device Summit 2009
June 2, 2009
June 3, 2009
CLE Credits are offered for this event.
Details
Stanford Park Hotel
100 El Camino Real
Menlo Park, California
Join former FDA and Congressional staffers and longtime counselors in a two-day summit that provides insight into current FDA, CMS, OIG, and State requirements and policies of critical importance to medical device manufacturers.
Agenda
Day One
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8:00 AM |
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Registration and Continental Breakfast |
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8:30 AM |
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Welcome and Introductions |
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8:45 AM |
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Hot Topics in Clinical Trials and IDEs |
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9:30 AM |
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PMA Process: Fundamental Concepts and New Challenges |
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10:15 AM |
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Navigating Through the 510(k) Process |
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11:00 AM |
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FDA's Policies on Off-Label Promotion and Marketing |
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11:45 AM |
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Interactive Hypothetical: Group Discussion of "Real Life" Scenarios |
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12:30 PM |
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Lunch: Discussion of Political Landscape |
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1:30 PM |
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Building Effective Systems for Medical Device Reporting and Corrections/Removals |
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2:30 PM |
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The Quality System Regulation: Basic Principles and Emerging Issues |
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3:15 PM |
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The FDA Enforcement Landscape |
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4:00 PM |
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Interactive Hypothetical: Group Discussion of "Real Life" Scenarios |
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5:00 PM |
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Reception |
Day Two
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8:00 AM |
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Continental Breakfast |
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8:30 AM |
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Maximizing Payment: Navigating Coding and Reimbursement |
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10:00 AM |
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Break |
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10:15 AM |
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Federal Regulation of Advertising, Promotion, Sales and Collaboration with Healthcare Professionals: Antikickback Statute, False Claims Act, Stark Law, FTC Act, and Foreign Corrupt Practices Act |
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11:45 AM |
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Understanding and Applying the AdvaMed Code and Other Industry Codes |
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12:30 PM |
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Lunch: Discussion of Preemption Issues, Paul Clement and Fritz Zimmer, King & Spalding |
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1:30 PM |
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Federal Disclosure and Transparency Requirements: Physician Sunshine Payments Act |
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1:45 PM |
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State Regulation of Interactions with Customers and Patients |
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2:30 PM |
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Break |
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2:45 PM |
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A Look at "Real Life" Scenarios (Hypothetical Issues and Enforcement Actions) |
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4:00 PM |
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Achieving the Right Balance of Business and Compliance |
King & Spalding Speakers:
- Edward Basile, Senior Partner, FDA & Life Sciences
- Jennifer Bragg, Partner, FDA & Life Sciences
- Jeffrey Bucholtz, Partner, Litigation & Antitrust
- Paul Clement, Partner, Litigation & Antitrust
- Daniel Donovan, Partner, Government Advocacy & Public Policy
- Pamela Forrest, Partner, FDA & Life Sciences
- Anne Kelly, Senior Good Manufacturing Practices Expert, FDA & Life Sciences
- Laura Loeb, Partner, FDA & Life Sciences
- Beverly Lorell, M.D., Senior Medical and Policy Advisor, FDA & Life Sciences
- Seth Lundy, Partner, FDA & Life Sciences
- Elaine Tseng, Partner, FDA & Life Sciences
- Fritz Zimmer, Partner, Tort & Environmental Litigation
PricewaterhouseCoopers Speakers:
- Peter Claude, Partner, Pharmaceutical and Life Sciences Advisory
- Jeffrey Rosenbaum, Director, Pharmaceutical and Life Sciences Advisory
Sponsorship assistance from
Registration:
Before April 30 - $99
After April 30 - $199
Registration Deadline: May 29, 2009. Due to exceptionally high interest in this event, we have reached our registrant capacity sooner than expected. Should you wish to be added to our wait list, please click here.
Continuing Education Credit
CLE credit will be applied for in California, Georgia, New York, Texas and Virginia, and a Certificate of Attendance will be provided for attorneys licensed in other states to use to apply for CLE credit. King & Spalding LLP, 1180 Peachtree Street NE, Atlanta, GA, 30309. CA Provider #10947.
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