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DISCLOSURE SUMMIT AGENDA: DAY I
Wednesday, February 5, 2014
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OPENING PLENARY SESSION: THE SUNSHINE ACT
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1:00 pm
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Welcome and Overview
Margaret K. Feltz, Esq.
Director, Corporate Compliance, Purdue Pharma LP; Executive Committee, Pharmaceutical Compliance Forum, Stamford, CT (Co-chair)
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THE US REGULATORY SETTING OVERVIEW
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1:15 pm
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The Sunshine Regulations
Toula Bellios
Director, Division of Policy and External Partnership, Center for Program Integrity, Data Sharing and Partnership Group, Baltimore, MD
Presentation Material (Acrobat)
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2:00 pm
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Chief Compliance Officer Roundtable: How Disclosure/Transparency Compliance Fits into a Successful Global Compliance Program
Christine Mikail, Esq.
Executive Vice President, General Counsel and Chief Compliance Officer, Dendron, Former Senior Vice President, Corporate Development, Savient Pharmaceuticals, Inc., Former February 2011 - February 2012 (1 year 1 month) Vice President, General Counsel & Secretary, ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, New York, NY
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Bert Weinstein, Esq.
Vice President, Corporate Compliance, Purdue Pharmaceuticals; Former Vice President and Assistant General Counsel, Merck, Stamford, CT
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Caroline West, Esq.
Senior Vice President, Chief Compliance and Risk Officer, Shire Pharmaceuticals, Inc.; Former Vice President, Global Legal Compliance, Aventis, Philadelphia, PA
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John Patrick Oroho, Esq.
Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLC; Principal, Porzio, Bromberg & Newman PC, Morristown, NJ (Co-Moderator)
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Kelly N. "Nikki" Reeves, MPA, JD
Partner, King & Spalding LLP, Washington, DC (Co-Moderator)
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3:00 pm |
Break
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3:30 pm |
Compliance Data Metrics and Analytics
This session will focus on how data can be leveraged to provide business insights and trends to enable life sciences companies to monitor sales and marketing activities and strategize on future HCP/HCO facing investments.
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Bharathram Lakshmivarahan
Director, Pharmaceutical & Life Sciences Advisory, PwC, Philadelphia, PA
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David Wysocky
Partner, PwC, Florham Park, NJ
Presentation Material (Acrobat)
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4:00 pm |
Assumptions and Completing Context Boxes: To Do or Not to Do; That is the Question
- The Agency's stated purposes with respect to assumptions letters and context boxes
- The pros and cons of submitting an assumptions letter to the Centers for Medicare and Medicaid Services
- Strategies for documenting assumptions
- Creating an internal assumptions document, whether or not your company submits an assumptions letter to the Agency
- How to effectively use context boxes to document transaction-level information that could not otherwise be used in the transparency report
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Meenakshi Datta, Esq.
Partner, Sidley Austin LLP, Chicago, IL
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Angela Fifelski, Esq.
Corporate Counsel, Baxter, Deerfield, IL
Presentation Material (Acrobat)
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4:30 pm |
Managing the Dispute Resolution Process
- Review of the Sunshine Rule's Minimum Requirements for Dispute Resolution
- Discussion of Best Practices for Effective Dispute Resolution Management
- Audience Benchmarking of Dispute Resolution Procedures
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Julie Brubaker, Esq.
Compliance Officer, Biomet Warsaw Operations; Former Deputy Solicitor General, Indiana Attorney General, Warsaw, IN
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Margaret K. Feltz, Esq.
Director, Corporate Compliance, Purdue Pharma LP; Executive Committee, Pharmaceutical Compliance Forum, Stamford, CT
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Ronald L. Wisor, Jr. Esq.
Partner, Hogan Lovells US LLP, Washington, DC
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5:15 pm |
Technology Solutions: Panelists from Leading Technology Firms Provide Insights on Current and Future Trends in Aggregate Spend Technology
- Overview of the Current Landscape and Types of Solutions on the Market
- Technologist Perspective on what Makes a Successful Partnership
- Views on Best Practice Approaches by Clients
- Review Newest Features and Pending Enhancements
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Michael D. Bell, Esq.
Founder and President, R-Squared, Princeton, NJ
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Susan Hill
Senior Vice President, Business Development, AHM, Philadelphia, PA
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John Patrick Oroho, Esq.
Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLC; Principal, Porzio, Bromberg & Newman PC, Morristown, NJ
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Dean Rossi
Founder and President, Alanda, New Brunswick, NJ
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Don Soong
Vice President of Strategic Solutions, Cegedim Relationship Management, Richmond, VA
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Jon Wilkenfeld, MBA
President, Potomac River Partners, Vienna, VA (Moderator)
Presentation Material (Acrobat)
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6:15 pm |
Adjournment and Networking Reception
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Go to Agenda:
Day 2 | Day 3
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