King & Spalding and The Gray Sheet, An Elsevier Business Intelligence (EBI) Publication, invite you to attend the West Coast Medical Device Summit.
Stanford Park Hotel
100 El Camino Real
Menlo Park, CA 94025
Summit Agenda
Featured Industry Participant: Clair O’Donovan, Senior VP, Quality and Regulatory, Beckman Coulter
DAY 1 - MORNING: October 17
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7:00 - 7:30 am
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Registration and Continental Breakfast |
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7:30 - 8:15 am
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“Early Bird” Presentation
FDASIA: What Medical Device Companies Need to Know |
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8:15 - 8:25 am
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Welcome and Introductions |
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8:25 - 9:10 am
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Sunshiny Day is Today: Federal and State Transparency Update |
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9:10 - 9:50 am
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Q&A with FDA: Post-Market Signaling, Section 522 Requirements, Data Mining and More |
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9:50 - 10:00 am
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Break |
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10:00 - 10:45 am
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HIPAA/HITECH: Direct and Indirect Implications for Device |
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10:45 - 11:30 am
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We’ve Got an App for That: Mobile Health |
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11:30 - 12:00 pm
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Election Year Politics: Predictions & What it Means for You |
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12:00 - 1:00 pm
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Buffet Lunch |
DAY 1 - AFTERNOON
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1:00 - 1:45 pm
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De-Mystifying Recalls |
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1:45 - 2:30 pm
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Lessons Learned from the Lauren Stevens Case |
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2:30 - 2:45 pm
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Break |
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2:45 - 3:30 pm
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Clinical Research and Post-Market Studies: New Scrutiny and Expectations |
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3:30 - 4:15 pm
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Unique Device Identifiers (Pre-Taped) |
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4:15 - 5:00 pm
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Anatomy of an Investigation |
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5:00 - 5:30 pm
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First Day Closing Remarks and Completion of Evaluations |
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5:30 - 7:00 pm
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Wine Tasting with Ed Basile: California Wines |
DAY 2: October 18
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7:00 - 8:00 am
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Continental Breakfast |
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8:00 - 8:45 am
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Hot Topics for Medical Device Companies |
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8:45 - 9:30 am
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Supplier Quality/Globalization of Medical Devices |
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9:30 - 10:15 am
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How to be Social: Important Developments in Social Media Regulation |
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10:15 - 10:30 am
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Break |
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10:30 - 11:15 am
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Just When You Have Mastered the Premarket Pathways . . . FDA Changes the Rules |
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11:15 - 12:00 pm
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FCPA Focus on the Medical Device Industry |
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12:00 - 12:15 pm
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Closing Remarks and Completion of Evaluations |
King & Spalding Featured Speakers
- Edward Basile, Senior Partner and Co-Chair, FDA/Life Sciences Practice Group
- Mark Brown, Partner, FDA/Life Sciences Practice Group
- Gina Cavalier, Partner, FDA/Life Sciences Practice Group
- Laurie Clarke, Partner, FDA/Life Sciences Practice Group
- George Crawford, Senior Government Relations Advisor, Government Advocacy and Public Policy
- Dan Donovan, Partner, Government Advocacy and Public Policy
- Governor Robert Ehrlich, Senior Counsel, Government Advocacy and Public Policy
- Pam Forrest, Partner, FDA/Life Sciences Practice Group
- Zack Harmon, Partner, Special Matters and Government Investigations
- Marian Lee, Partner, FDA/Life Sciences Practice Group
- Seth Lundy, Partner and Deputy Co-Chair, FDA/Life Sciences Deputy Practice Group
- Beverly Lorell, M.D., Senior Medical and Policy Advisor, FDA/Life Sciences Group
- Steve Niedelman, Lead Quality System and Compliance Consultant, FDA/Life Sciences Practice Group
- Nikki Reeves, Partner, FDA/Life Sciences Practice Group
- Laura Snodgrass, Associate, FDA/Life Sciences Practice Group
- Tom Spulak, Partner, Government Advocacy and Public Policy
- Elaine Tseng, Partner, FDA/Life Sciences Practice Group
FDA Speakers
- Jay Crowley, FDA, CDRH Senior Advisor for Patient Safety
- Dr. Tom Gross; FDA, Director of CDRH, Office of Surveillance and Biometrics
Industry and Academic Speakers
- Clair O’Donovan, Senior VP, Quality and Regulatory, Beckman Coulter
- Ray Kolls, Director, Berkeley Research Group, LLC
- Chris White, Executive Vice President, General Counsel and Secretary, AdvaMed
Registration
By September 28 - $199 per person
After September 28 - $299 per person
Registration Deadline: October 15, 2012
Accommodations
Discount rate is: $219. Must reserve by September 30 and must mention King & Spalding in order to receive the group rate. Reservations can be made by calling the Stanford Park Hotel reservations department direct at +1 866 241 2431 (toll free) or +1 650 322 1234, or online by clicking here. (Reservation must include the following: Guest Name, Arrival/Departure Date, Address, Phone # & Name of Group).
We hope you will join us at the West Coast Medical Device Summit.
Continuing Education Credit: CCLE credits will be applied for in California, Georgia, New York, Rhode Island, Texas, and if needed Virginia. Certificates of Attendance will be emailed to all participants after the program. King & Spalding, 1180 Peachtree Street, Atlanta, GA 30309. California Provider # 19047.
