Pharmaceutical Regulatory and Compliance Congress: Agenda: Day 2

	Day II: Thursday, November 3, 2011

	7:00 a.m.			Registration Opens: Continental Breakfast in Exhibit Hall
	MORNING PLENARY SESSION
	8:00 a.m.			Welcome and Introduction to Day II Morning Gary DelVecchio Executive Director, US Pharmaceutical Compliance and Ethics, Bristol-Myers Squibb Company, Plainsboro, NJ (Co chair)
	8:15 a.m.			Sunshine Act Implementation Kendra A. Martello, Esq. Assistant General Counsel, Pharmaceutical Research and Manufacturers of America (PhRMA), Washington, DC Presentation Material (Acrobat)
	8:45 a.m.			FCPA and UK Bribery Act Enforcement and Compliance Update Charles E. Cain, Esq. Assistant Director, FCPA Unit, Director of the Division of Enforcement, Securities and Exchange Commission, Washington, DC Nathaniel Edmonds, Esq. Assistant Chief, Foreign Corrupt Practices Act Unit, Fraud Section, Criminal Division, US Department of Justice, Washington, DC Vivian Robinson, Esq. Partner, McGuireWoods; Former General Counsel of the UK Serious Fraud Office; Former Head, QEB Hollis Whiteman Chambers, Recorder of the Crown Court and Treasurer of Inner Temple, London, UK Ted Acosta, Esq. Principal, Ernst & Young LLP; Former Senior Counsel, Office of Inspector General, US Department of Health and Human Services, New York, NY and Paris, France (Moderator) Permission to post not granted
	9:30 a.m.			Personal Accountability and Individual Liability of In-house Counsel and Chief Compliance Officers and Exclusions from Federal Health Programs Lessons of the Stevens Case Colleen A. Conry, Esq. Partner and Co-Chair, Government Enforcement Practice Group, Ropes & Gray; Former Senior Litigation Counsel, Criminal Division, Fraud Section, US Department of Justice, Washington, DC Lessons of the Forrest and Purdue Paul E. Kalb, JD, MD Partner and Head, Healthcare Practice, Sidley Austin LLP, Washington, DC Presentation Material (Acrobat)
	10:00 a.m.			Break
	10:30 a.m.			Personal Accountability and Individual Liability of In-house Counsel and Chief Compliance Officers and Exclusions from Federal Health Programs Best Practices to Avoid Individual Liability and Exclusion Colleen A. Conry, Esq. Partner and Co-Chair, Government Enforcement Practice Group, Ropes & Gray; Former Senior Litigation Counsel, Criminal Division, Fraud Section, US Department of Justice, Washington, DC Gary F. Giampetruzzi, Esq. Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY Paul E. Kalb, JD, MD Partner and Head, Healthcare Practice, Sidley Austin LLP, Washington, DC Arjun Rajaratnam, Esq. Chief Compliance Officer, Smith & Nephew; Former Compliance Officer, US Pharmaceuticals, GlaxoSmithKline; Former Member, PCF Executive Committee, Durham, NC Thomas M. Gallagher, Esq. Partner and Chair, White Collar and Corporate Investigations Practice Group, Pepper Hamilton LLP; Former Prosecutor, Criminal Division, US Attorney's Office, Eastern District of Pennsylvania, Philadelphia, PA (Moderator)
	11:15 a.m.			Compliance Professional Responsibilities in the Pharmaceutical, Biotech & Medical Device Industries Christopher D. Zalesky, JD, CCEP, RAC Vice President Global Policy and Guidance, Johnson & Johnson Health Care Compliance and Privacy, New Brunswick, NJ Presentation Material (Acrobat)
	11:45 a.m.			Board and Executive Responsibilities and Certifications Nancy M. Coddington, PhD Senior Director, US Business Compliance, AstraZeneca Pharmaceuticals LP, Wilmington, DE Jeanine Jiganti, Esq. Vice President and Chief Compliance Officer, Takeda Pharmaceuticals North America, Deerfield, IL Lloyd A. Rowland, Esq. Vice President and Chief Compliance Officer, Amylin Pharmaceuticals, San Diego, CA Jonathon L. Kellerman Partner, Global Pharmaceutical Advisory Services Group, PricewaterhouseCoopers LLP, Florham Park, NJ (Moderator)
	12:15 p.m.			Networking Lunch
	DAY II AFTERNOON TRACK SESSIONS I
	TRACK I:			Taking your Compliance Program to the Next Level Timothy Ayers, Esq. Associate General Counsel, Executive Director of Compliance, Seattle Genetics, Bothell, WA (Co chair) Elizabeth V. Jobes, Esq. Vice President and Chief Compliance Officer, Adolor; Former Assistant District Attorney, Philadelphia, PA, Exton, PA (Co chair)
	1:15 p.m.			PwC Annual Compliance Organization and Administration Survey Keith M. Korenchuk, JD, MPH Partner, Arnold & Porter LLP, Washington, DC Erinn Hutchinson Director, PricewaterhouseCoopers LLP, Philadelphia, PA Victoria Browning Senior Director, Corporate Compliance, Allergan, Irvine, CA Permission to post not granted
	1:45 p.m.			Responding to Health Reform: How Pharma and Device Manufacturers can Participate in Delivery System and Payment Reform-Strategic, Legal and Compliance Implications Constance A. Wilkinson, Esq. Member, Epstein Becker & Green, PC, Washington, DC Presentation Material (Acrobat)
	2:15 p.m.			Taking your Compliance Program to the Next Level: Building a Culture of Compliance; Compliance Program Branding; Making Policies and Procedures Relevant to Internal Constituencies; Compliance, Eliminator or Manager of Risk; Envisioning the Compliance Professional of the Future; Recruitment and Retention Mark Jones, Esq. Director, Compliance, Onyx Pharmaceuticals, Inc., South San Francisco, CA Heather Reilly Powell, Esq. Director, Compliance Training and Reporting, Daiichi Sankyo, Inc.; Former Associate Director, Global Compliance, Cephalon, Inc., Parsippany, NJ Michelle Vella, Esq. Assistant General Counsel, Compliance Division, Pfizer Inc., Rockford, IL Christopher D. Zalesky, JD, CCEP, RAC Vice President Global Policy and Guidance, Johnson & Johnson Health Care Compliance and Privacy, New Brunswick, NJ Timothy Ayers, Esq. Associate General Counsel, Executive Director of Compliance, Seattle Genetics, Bothell, WA (Moderator) Elizabeth V. Jobes, Esq. Vice President and Chief Compliance Officer, Adolor; Former Assistant District Attorney, Philadelphia, PA, Exton, PA (Moderator)
	3:15 p.m.			Break

	TRACK II:			Internal and External Investigations Update Jonathan L. Diesenhaus, Esq. Partner, Hogan Lovells US LLP; Former Senior Trial Counsel, Civil Division of the US Department of Justice, Washington, DC (Co chair) Constance A. Wilkinson, Esq. Partner, Epstein Becker & Green, Washington, DC (Co chair)
	1:15 p.m.			Defending Government Pharmaceutical/ Device Investigations and Qui Tam Litigation Mark A. Jensen, Esq. Partner, King & Spalding LLP, Washington, DC
	1:40 p.m.			Responding to State Attorneys General Investigations Barry H. Boise, Esq. Partner, Pepper Hamilton LLP, Philadelphia, PA Presentation Material (Acrobat)
	2:05 p.m.			Analyzing Data in Off Label and Other Cases-From Production to Damages Thomas A. Gregory, CPA, CFA Partner, Fraud Investigation and Dispute Services, Ernst & Young LLP, Atlanta, GA Kathleen Meriwether, Esq. Principal, Fraud Investigation and Dispute Services, Ernst & Young LLP; Former Assistant United States Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA
	2:30 p.m.			Working with the Board of Directors in Responding to an Investigation Constance A. Wilkinson, Esq. Partner, Epstein Becker & Green, Washington, DC
	2:55 p.m.			Ethical Challenges of Internal Investigations and the Representation of Individuals in Light of the Government's New Focus on Individuals Jonathan L. Diesenhaus, Esq. Partner, Hogan Lovells US LLP; Former Senior Trial Counsel, Civil Division of the US Department of Justice, Washington, DC
	3:15 p.m.			Break

	TRACK III:			Fair Market Value Update Eric Siegel, JD, MBA Chief Compliance Officer, Incyte Corporation, Philadelphia, PA (Co chair) Paul J. Silver Managing Director and Practice Leader, Life Sciences Practice, Huron Consulting Group, Atlanta, GA (Co chair) Presentation Material (Acrobat)
	1:15 p.m.			International FMV: Growing Trends and Methodology Approaches Bridget Bourgeois Partner, Ernst & Young LLC, Atlanta, GA Mark A. DeWyngaert, PhD Managing Director, Life Sciences Practice, Huron Consulting Group, New York, NY Jeff Rosenbaum Global Head, Ethics & Compliance, Novartis Oncology, Florham Park, NJ Presentation Material (Acrobat)
	2:15 p.m.			Fair Market Value and the Emerging Company Robert Scala Senior Director, Ethics & Compliance, Eisai Inc., Woodcliff Lake, NJ Eric Siegel, Esq. Chief Compliance Officer, Incyte Corporation, Philadelphia, PA Presentation Material (Acrobat)
	2:45 p.m.			Operationalizing Fair Market Value Dieter Peise Associate Director Ethics & Compliance, Novartis, New York, NY Presentation Material (Acrobat)
	3:15 p.m.			Break

	TRACK IV:			FCPA and UK Bribery Act Compliance Update John T. Bentivoglio, Esq. Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice, Washington, DC (Co chair) Gary F. Giampetruzzi, Esq. Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY (Co chair)
	1:15 p.m.			Focus on China: Assessing Your FCPA Risk Exposure in R&D and Manufacturing Operations, and Bracing for a New Era of Local Enforcement Hui Chen, Esq. Senior Corporate Counsel, Asia-Pacific Regional Lead, International Compliance Investigations, Pfizer Inc., New York, NY Peter S. Spivack, Esq. Partner, and Co-Leader, Investigations, White Collar and Fraud Practice Area, Hogan Lovells US LLP, Washington, DC Presentation Material (Acrobat)
	2:00 p.m.			Maintaining Research Integrity While Minimizing Bribery Risks in Foreign Clinical Trials: Effective Due Diligence and Oversight Strategies for your Doctors, CROs, and HCPs John T. Bentivoglio, Esq. Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice, Washington, DC Sue Seferian, Esq. Health Care Compliance Officer, Johnson & Johnson Office of Health Care Compliance & Privacy, Titusville, NJ Presentation Material (Acrobat)
	2:45 p.m.			UK Bribery Act Update Vivian Robinson, Esq. Partner, McGuireWoods; Former General Counsel of the UK Serious Fraud Office; Former Head, QEB Hollis Whiteman Chambers; Recorder of the Crown Court and Treasurer of Inner Temple, London, UK Presentation Material (Acrobat)
	3:15 p.m.			Break

	TRACK V:			Compliance Lessons Learned from Medical Devices Sujata T. Dayal, Esq. Corporate Vice President and Chief Compliance Officer, Biomet; Former Counsel, Domestic Legal Operations, Abbott Laboratories; Former Member, PCF Executive Committee, Warsaw, IN (Co chair) Arjun Rajaratnam, Esq. Chief Compliance Officer, Smith & Nephew; Former Compliance Officer, US Pharmaceuticals, GlaxoSmithKline; Former Member, PCF Executive Committee, Durham, NC (Co chair) Presentation Material (Acrobat)
	1:15 p.m.			Compliance Lessons Learned from Medical Devices: Building Global Compliance Organizations Operating Under Deferred Prosecution Agreements (DPAs) Collaborating with HCPs-Physician Inventors Managing Distributors and Sales Agents Sales Reps in the Operating Room Emerging GMP/QSR Issues Global Monitoring Programs Scott Bass, Esq. Partner and Head, Global Life Sciences Team, Sidley Austin LLP, Washington, DC Presentation Material (Acrobat) Stephen J. Immelt, Esq. Partner, Hogan Lovells; Former Assistant U.S. Attorney, District of Maryland, US Department of Justice, Baltimore, MD Presentation Material (Acrobat) Sandra Cohen Kalter Vice President and Chief Regulatory Counsel, Medronic, Inc., Washington, DC Gregory H. Levine, Esq. Partner and Co chair, Life Sciences Practice Group, Ropes & Gray, Washington, DC Presentation Material (Acrobat) David E. Matyas, Esq. Member, Epstein Becker & Green, Washington, DC Presentation Material (Acrobat) Sujata T. Dayal, Esq. Corporate Vice President and Chief Compliance Officer, Biomet; Former Counsel, Domestic Legal Operations, Abbott Laboratories; Former Member, PCF Executive Committee, Warsaw, IN (Moderator) Arjun Rajaratnam, Esq. Chief Compliance Officer, Smith & Nephew; Former Compliance Officer, US Pharmaceuticals, GlaxoSmithKline; Former Member, PCF Executive Committee, Durham, NC (Moderator)
	3:15 p.m.			Break

	DAY II AFTERNOON TRACK SESSIONS II
	TRACK VI:			Advanced Issues in Auditing and Monitoring Jack T. Tanselle Director, Healthcare Dispute, Compliance and Investigation Practice, Navigant Consulting, Inc., Chicago, IL (Chair)
	3:45 p.m.			Monitoring Medical Affairs (MSLs, IIS, Medical Information) Eileen Erdos Principal, Fraud Investigation and Dispute Services, Ernst & Young LLP, Chicago, IL Kathleen Meriwether, Esq. Principal, Fraud Investigation and Dispute Services, Ernst & Young LLP; Former Assistant United States Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA Presentation Material (Acrobat)
	4:25 p.m.			Field Force Monitoring Dennis K. Barnes, JD, CPA Director, Healthcare Dispute, Compliance and Investigation Practice, Navigant Consulting, Inc., Philadelphia, PA Presentation Material (Acrobat)
	5:05 p.m.			Use of Outside Vendors in Monitoring Compliance Programs Fred Eaton, MBA Partner and Chair, Market Value Practice, Polaris Management Partners, New York, NY Presentation Material (Acrobat)
	5:45 p.m.			Adjournment

	TRACK VII:			Healthcare Professionals Compliance Update-the Hottest Emerging Issues in Industry/HCP Relationships Maureen Doyle-Scharff, MBA, FACME Senior Director, Team Lead, Medical Education Group, Pfizer, Columbus, OH (Co chair) Seth H. Lundy, Esq. Partner, King & Spalding LLP, Washington, DC (Co chair)
	3:45 p.m.			Challenges Implementing Recent CIA Requirements - Lessons Learned Seth H. Lundy, Esq. Partner, King & Spalding LLP, Washington, DC Tracy Mastro, MBA Director, Life Sciences Practice, Huron Consulting Group, Washington, DC Scott A. Memmott, Esq. Partner, Morgan Lewis; Former Trial Attorney, Civil Division, US Department of Justice; Former Special Assistant US Attorney in Norfolk, Virginia, Washington, DC Daniel Moynihan, Esq. Chief Compliance Officer and Former Associate General Counsel, EMD Serono, Rockland, MA Presentation Material (Acrobat)
	4:45 p.m.			Risk Stratification and Monitoring of Industry-funded Third Party Educational Activities, Grants and Charitable Contributions Peg Bollella, PharmD, CCMEP Director of Strategic Grant Operations and Metrics, sanofi-aventis US, a Sanofi Company, Bridgewater, NJ Maureen Doyle-Scharff, MBA, FACME Senior Director, Team Lead, Medical Education Group, Pfizer, Columbus, OH Edmund Greenidge, JD Director, Grants and Charitable Contributions, Janssen Biotech, Inc., Horsham, PA Presentation Material (Acrobat)
	5:45 p.m.			Adjournment

	TRACK VIII:			Government Payment and Price Reporting Update William A. Sarraille, Esq. Partner, Sidley Austin LLP, Washington, DC (Co chair) Jerry Wolf Director, Healthcare Dispute, Compliance and Investigation Practice, Navigant Consulting, Inc., Philadelphia, PA (Co chair)
	3:45 p.m.			Government Price Reporting Update Jeffrey L. Handwerker, Esq. Partner, Arnold & Porter, Washington, DC Presentation Material (Acrobat)
	4:15 p.m.			Quick Diagnostics for the Compliance Officer: Process and System Susan Dunne Director, Life Sciences Practice, Huron Consulting Group, Washington, DC Mark Linver Managing Director, Life Sciences Practice, Huron Consulting Group, New York, NY Presentation Material (Acrobat)
	5:00 p.m.			340B Expansion and Diversion Issues Bradford Lang Public Health Analyst, Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs, Rockville, MD Presentation Material (Acrobat) William A. Sarraille, Esq. Partner, Sidley Austin LLP, Washington, DC Presentation Material (Acrobat) William H. von Oehsen III, Esq. Principal, Powers Pyles Sutter & Verville PC, Washington, DC Presentation Material (Acrobat)
	5:45 p.m.			Adjournment

	TRACK IX:			Research & Development and Clinical Trials Kelly B. Freeman, PhD Ethics and Compliance Officer, Eli Lilly and Company; Executive Committee Member, Pharmaceutical Compliance Forum, Indianapolis, IN (Co chair) Daniel A. Kracov, Esq. Partner and Chair, FDA and Healthcare Practice, Arnold & Porter LLC, Washington, DC (Co chair)
	3:45 p.m.			Updating the Common Rule Governing Human Subjects Research Protections Jerry A. Menikoff, MD, JD Director, Office for Human Research Protections, Office of Public Health and Science, US Department of Health and Human Services; Former Director, Office of Human Subjects Research, National Institutes of Health, Rockville, MD Presentation Material (Acrobat)
	4:15 p.m.			Risk Management in Clinical Development Jeffrey S. Kasher, PhD Vice President Global Clinical Development, Eli Lilly and Company, Indianapolis, IN Presentation Material (Acrobat) Andy Lee Senior Vice President, Head Global Clinical Operations, Genzyme, Cambridge, MA Winifred (Ann) Meeker-O'Connell, MS Acting Associate Director of Risk Science, Intelligence and Prioritization, Office of Scientific Investigation (OSI), Center for Drug Evaluation and Research (CDER), Food and Drug Administration, Silver Spring, MD Presentation Material (Acrobat) Marc B. Wilenzick, Esq. Compliance Officer/Chief Compliance Counsel, R&D & Medical, Pfizer Inc, New York, NY Presentation Material (Acrobat) Handout Material (Acrobat)
	5:15 p.m.			Mini Summit Faculty Discussion Panel: Maintaining Compliance and Quality with Increasing Outsourcing to Contract Research Organizations Michael Swiatocha, MS Managing Director, Rx4HCC, Former Vice President and Compliance Officer, Schering-Plough Research Institute, Pennington, NJ
	5:45 p.m.			Adjournment

	TRACK X:			Global Pharma and Device Compliance Issues Sue Egan Director and Principal Consultant, Sue Egan Associates; Former Vice President Compliance, AstraZeneca, Great Missenden, Buckinghamshire, UK (Co chair) Keith M. Korenchuk, JD, MPH Partner, Arnold & Porter LLP, Washington, DC, USA (Co chair)
	3:45 p.m.			Introduction and Overview Global Compliance Program Structure, Staffing and Decision Making Global Compliance Program Team Training and Development, Continuously Improving the Team Dealing with Centralized vs. Local Initiatives and Central Oversight; Balancing Local vs. Central Decision Making Escalation Strategies; When to Ask for Support Working within Different Cultures and Overcoming Barriers to Change Providing Training that Works on the Local Level Hui Chen, Esq. Senior Corporate Counsel, Asia-Pacific Regional Lead, International Compliance Investigations, Pfizer Inc., New York, NY Sujata T. Dayal, Esq. Corporate Vice President and Chief Compliance Officer, Biomet; Former Counsel, Domestic Legal Operations, Abbott Laboratories; Former Member, PCF Executive Committee, Warsaw, IN John DeMarrais Managing Director, KPMG LLP, Short Hills, NJ Caroline West, Esq. Senior Vice President, Chief Compliance and Risk Officer, Shire, Philadelphia, PA Sue Egan Director and Principal Consultant, Sue Egan Associates; Former Vice President Compliance, AstraZeneca, Great Missenden, Buckinghamshire, UK (Moderator) Keith M. Korenchuk, JD, MPH Partner, Arnold & Porter LLP, Washington, DC, USA (Moderator)
	5:45 p.m.			Adjournment