backKing & Spalding and The Gray Sheet invite you to attend the Medical Device Summit.
Sheraton Palo Alto Hotel
625 El Camino Real
Palo Alto, California 94301
Summit Agenda
Featuring Government and Industry Participants
DAY 1 - MORNING: September 16
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7:00 - 8:15 am
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Registration and Continental Breakfast |
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8:15 - 8:30 am
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Welcome and Introductions |
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8:30 - 9:15 am
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FDA Medical Device Enforcement – Trends and Hot Topics |
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9:15 - 10:00 am
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CDRH Compliance Update: An Interview with FDA's Steven Silverman |
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10:00 - 10:15 am
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Break |
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10:15 - 11:00 am
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How to Respond Effectively to a Form FDA-483 or Warning Letter: Best Practices and Common Pitfalls |
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11:00 - 11:45 am
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Trends and Recent Developments in Medical Device Recalls, including Q&A, with FDA's Ronny (Ron) Brown |
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11:45 am- 12:30 pm
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ODE Program Updates and Priorities with FDA's Jonette (Joni) Foy |
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12:30 - 1:15 pm
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Buffet Lunch |
DAY 1 - AFTERNOON
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1:30 - 2:00 pm
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What's New in Premarket Review |
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2:00 - 2:45 pm
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Key Developments in Device Advertising and Promotion |
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2:45 - 3:00 pm
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Break |
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3:00 - 3:30 pm
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Recall Roundtable |
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3:30 - 4:15 pm
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Medical Device Technology Transactions: Navigating the Intersection of Hardware, Software and Biology |
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4:15 - 5:00 pm
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Get the Deal Done: Identifying and Managing Risk |
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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 - 6:30 pm
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Wine Tasting |
DAY 2: September 17
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7:45 - 8:30 am
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Continental Breakfast |
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8:30 - 9:15 am
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Medical Device Product Liability Update |
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9:15 - 10:15 am
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Medical Devices in the EU: From the '93 Directive to the New Regulation and Hot Topics! |
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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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DOJ Enforcement: Scrutiny on Patient Safety and Clinical Research |
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11:15 am - 12:00 pm
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Discounts, Donations, Demos & More: Top Healthcare Compliance Issues for Device Companies |
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12:00 - 12:15 pm
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Closing Remarks and Completion of Evaluations |
Government Speakers
- Ronny (Ron) Brown, Chief, Recall Branch, CDRH, FDA
- Jonette (Joni) Foy, Ph.D., Deputy Director for Engineering & Science Review, Office of Device Evaluation, CDRH, FDA
- Steven Silverman, Director, Office of Compliance, CDRH, FDA
King & Spalding Speakers
- Edward Basile, Senior Partner, FDA/Life Sciences Practice Group
- Mark Brown, Partner and Chair, FDA/Life Sciences Practice Group
- Laura Bushnell, Partner, Corporate Practice Group
- Gina Cavalier, Partner, FDA/Life Sciences Practice Group
- Thomas Duley, Partner, Corporate Practice Group
- Pamela Forrest, Partner, FDA/Life Sciences Practice Group
- Ulf Grundmann, Partner, FDA/Life Sciences Practice Group
- Marian Lee, Partner, FDA/Life Sciences Practice Group
- Beverly Lorell, M.D., Senior Medical and Policy Advisor, FDA/Life Sciences Practice Group
- Seth Lundy, Partner and Deputy Co-Chair, FDA/Life Sciences Practice Group
- Steve Niedelman, Lead Quality System and Compliance Consultant, FDA/Life Sciences Practice Group
- Kelly (Nikki) Reeves, Partner, FDA/Life Sciences Practice Group
- John Richter, Partner, Special Matters and Government Investigations Practice Group
- Cheryl Sabnis, Partner, Tort & Environmental Practice Group
- Elaine Tseng, Partner, FDA/Life Sciences Practice Group
- Fritz Zimmer, Partner, Tort & Environmental Practice Group
Registration
By August 25 - $199 per person
After August 25 - $299 per person
Registration Deadline: September 12, 2014
Accommodations
Discount rate is: $299. Must reserve by September 1 and must mention King & Spalding Medical Device Summit in order to receive the group rate. Reservations can be made by calling the Sheraton Palo Alto Hotel at +1 800 325 3535, by email at Sheratonreservations@pahotel.com, or online by clicking here. (Reservation must include the following: Guest Name, Arrival/Departure Date, Address, Phone #, and Name of Group).
We hope you will join us at the 2014 Medical Device Summit.
Continuing Education Credit: CLE credits will be applied for in California, Georgia, New York, Texas, and if needed North Carolina and Virginia. For New York Barred lawyers: The content of this live, in-person program is considered Transitional and Non-Transitional and is approved for both experienced and newly admitted NY lawyers. Certificates of Attendance will be emailed to all participants after the program.
King & Spalding, 1180 Peachtree Street, Atlanta, GA 30309. California Provider # 19047.