Disclosure Summit: Agenda: Day II

DISCLOSURE SUMMIT AGENDA: DAY II Wednesday, March 28, 2012
7:00 am	Registration Commences
CLOSING PLENARY SESSION: CREATING THE PARADIGM SUNSHINE COMPLIANCE PROGRAM FOR THE FUTURE
8:00 am	Welcome and Introductions Karen Lowney Senior Director, Compliance, Teva Pharmaceuticals, Frazer, PA (Co chair)
	Trudy J. Seeley Senior Manager, Transparency Operations, Sanofi-Aventis, Bridgewater, NJ (Co chair)
8:15 am	Where Disclosure Meets Enforcement Virginia "Ginny" A. Gibson, Esq. Partner, Hogan Lovells US LLP; Former Executive Assistant US Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA
8:45 am	Understanding Aggregate Spend Awareness and Attitudes: Physician Survey Results and Case Study Tim Robinson, Esq. President, The Regulatory Law Group, PLLC; Executive Vice President & General Counsel, MMIS, Inc., New York, NY
9:15 am	Educating Physicians about the Sunshine Act Sarah K. Giesting, Esq. Associate, Pharmaceutical Industry Health Regulatory Practice Group, Epstein Becker & Green, New York, NY
9:45 am	Coordination of Compliance with Sunshine Act and Global Disclosure and Transparency Initiatives 2010 Industry Survey Key Findings William E. Buzzeo, MS Vice President and General Manager, Compliance, Solutions Division, Cegedim Relationship Management, Richmond, VA
10:15 am	Break
10:30 am	Panel on Global Transparency Jennifer Colapietro Partner, Transparency and Aggregate Spend Practice Lead, PricewaterhouseCoopers LLP, Florham Park, NJ Laura O'Donnell, Esq., Chief Compliance Counsel, GE Healthcare, Wauwatosa, WI
11:15 am	Case Study: Purdue Aggregate Spend Approach and Solution Danielle Bacco Manager, Corporate Compliance, Purdue Pharma LP, Stamford, CT Christine N. Bradshaw, Esq. Director, Regulatory and Compliance Services, Porzio Pharmaceutical Services, Associate, Porzio, Bromberg & Newman, Morristown, NJ
12:00 pm	Networking Luncheon
12:45 pm	Case Study: Sanofi-Aventis Aggregate Spend Approach and Solution Trudy J. Seeley Senior Manager, Transparency Operations, Sanofi-Aventis, Bridgewater, NJ
1:30 pm	Advanced Implementation Best Practices Discussion Facilitated by the Following Katherine E. Norris, MPA Director, Corporate Compliance, The Spectranetics Corporation, Colorado Springs, CO Jennifer Colapietro Partner, Transparency and Aggregate Spend, Practice Lead, PricewaterhouseCoopers LLP, Florham Park, NJ Marc Eigner, MS, MBA Partner, Polaris Management Partners, New York, NY Karen Lowney Senior Director, Compliance, Teva Pharmaceuticals, Frazer, PA Manny Tzavlakis Managing Director, Life Sciences Practice, Huron Consulting Group, New York, NY Jon Wilkenfeld, MBA President, Potomac River Partners, Vienna, VA Keith Korenchuk, Esq. Partner, FDA and Healthcare Practice, Arnold & Porter, Washington, DC (Moderator) Customer Master: Improved linkages between HCPs and HCOs Links to institutional conflicts Real-time changes to data Selection up-front vs. Match-merge Healthcare Organizations: Going beyond "Teaching Hospitals" Address challenges Incomplete government data Links to Customer Master Data Monitoring: Getting beyond outlier analysis Lessons learned from public disclosures (e.g. state sanction checks) Data Certification: How much data do you provide? How can anyone certify millions of transactions? Global Spend: Identification of Global Customer Master Capturing cross-border transactions (US affiliate spend on global HCPs, foreign affiliate spend on US HCPs) Capturing ex-US transactions on ex-US HCPs Gaining buy-in from ex-US counterparts Impact of FCPA, foreign laws - identification of Government Officials in Global Customer Master Clinical Spend Capture: Capture of PIs and Sub-Investigators for each trial Granular identification of line-item costs Equipment capture IIT's and post-marketing trials Impact on Sales & Marketing and Clinical: How will your business react if HCPs to refuse promotional activity tied to spend? How will the media impact affect commercial operations? What happens if your top-tier KOLs stop assisting in getting product message out or stop performing clinical trials? Will companies risk losing clinical researchers due to disclosurerelated concerns?
3:30 pm	Adjournment