Agenda
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Day 1 - Wednesday, March 11, 2015
Day 2 - Thursday, March 12, 2015
Day 1 - Wednesday, March 11, 2015
9:00 |
Best Practices for Updating Your Medical Device Compliance Program by Fortifying Your Protocols, Strengthening Your Team, and Creating a Culture of Living ComplianceGael Diane Tisack Elizabeth Cipolletti Teresa Ford In preparation for discussion of the main conference topics, join us for this unique interactive approach to enhancing your medical device compliance program. Benchmark with industry leaders to strengthen your current protocols in this interactive forum. With government enforcers increasingly pursuing fraud and abuse in the medical device industry, don’t miss this unique opportunity to learn best practices and get answers to your company’s specific compliance questions, whether a large or small organization.
9:00 a.m. to 12:00 p.m. (Registration begins at 8:30 a.m.) |
12:00 |
Registration for Main Conference |
12:45 |
Co-Chairs’ Welcoming Remarks |
1:00 |
Insiders’ Roundtable on Recent Enforcement and Compliance TrendsJacqueline Romero Betsy Van Hecke Hollie Foust Moderator:Virginia A. Gibson
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2:30 |
Under the Microscope: Managing, Defending and Curtailing Whistleblowers and Allegations under the False Claims ActLisa M. Noller Andrew Dahlinghaus Darren W. Alch
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3:30 |
Afternoon Refreshment Break |
3:45 |
Navigating the Federal Anti-Kickback Statute and Identifying the Specific Risks for Medical Device CompaniesThomas M. Gallagher Gregg Shapiro Saliha K. Greff
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4:45 |
Understanding and Adapting to New Guidance Regarding the Parameters of Conversation and Dissemination of Information Regarding Off- Label Use of Medical DevicesAnne K. Walsh Darren W. Alch
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5:30 |
Conference Adjourns to Day 2 |
Day 2 - Thursday, March 12, 2015
8:00 |
Continental Breakfast |
9:00 |
Co-Chairs’ Welcoming Remarks and Introduction of Keynote SpeakerRichard S. Liner Anne K. Walsh Betsy Van Hecke |
9:30 |
Keynote Address – Lessons Learned from the Most Recent Investigations, How to Modify Corporate Practices to Not Run Afoul of New Enforcement Priorities and Identifying Current Areas of ConcernCarmen M. Ortiz |
10:00 |
Lines in the Sand: Extracting Hard Lines from Government Guidance on Social MediaChristine Mikail Elise Fellner Roth
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11:00 |
Morning Refreshment Break |
11:15 |
CIAs: What You Need to Consider Before Signing, During Oversight, and What to Expect After Reaching the Finishing LineMark P. Goodman Jaime L.M. Jones Paige Slater
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12:15 |
Networking Lunch |
1:30 |
Navigating a Global Marketplace: Managing the Manufacturing, Sales and Distribution of Drugs and Medical Devices by Being Vigilant of the Latest Anti-Corruption PitfallsParth Chanda Michael Russell Clarke Katherine DeKam Maura K. Monaghan Moderator:Marco A. Gonzalez Jr.
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2:45 |
Afternoon Refreshment Break |
3:00 |
U.S. Attorney’s Office Roundtable: The Enforcers SpeakDavid S. Schumacher Keith V. Morgan David L. Kirman Zachary Cunha Jacob T. Elberg Moderator:Jack W. Pirozzolo DOJ announced it has no intentions on letting up on its pursuit of fraud and abuse in this industry, to the contrary, it has indicated criminal prosecutions will be on the rise. With new government regulations and guidance for enforcement priorities, don’t miss this unique opportunity to hear directly from the enforcers as they share their insights and touch on:
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4:30 |
The Sunshine Act: With Open Payments Now Live, What this Means for Your Compliance Program and Your Relationships with HCPs, Both Here and AbroadJodie Sherman Gillon Danielle Gallo
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5:30 |
Conference Adjourns |