Tenth Annual PharmaCongress: Agenda: Preconference Symposia & Day 1

	Wednesday, November 11, 2009 Preconference Symposia (Optional, choose one)

	7:00 a.m.			Congress Registration
	8:00 a.m.			Preconferences Commence; Choose one
	PRECONFERENCE I			PRECONFERENCE I: COMPLIANCE 101
				This interactive pre-conference session, designed for new compliance professionals, or those new to the pharmaceutical industry. Compliance resources will be provided. Margaret K. Feltz Associate Director, Corporate Compliance, Purdue Pharma LP, Stamford, CT (Co chair) Wendy C. Goldstein, Esq. Partner, Epstein Becker & Green P.C., New York, NY (Co chair) Presentation Material (Acrobat) Presentation Material (Acrobat) Presentation Material (Acrobat)
	8:00 a.m.			Introduction and Overview to the Seven Elements of an Effective Corporate Compliance Program Compliance Personnel and Infrastructure Written Standards Hotlines Training Auditing and Monitoring Investigations Screening and Discipline
	10:15 a.m.			Break
	10:30 a.m.			Interactive Practice Session to Discuss Elements of an Effective Compliance Program
	12:00 p.m.			Preconference Adjournment; Lunch on your Own
	PRECONFERENCE II			RECENT GOVERNMENT SETTLEMENTS AND LESSONS LEARNED
				During this pre-conference session, the panels will present and discuss recent settlements in the pharmaceutical industry and the lessons that can be drawn for meeting the government's expectations for state of the art compliance programs. 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) Peter S. Spivack, Esq. Partner, Hogan & Hartson, Washington, DC (Co chair)
	8:00 a.m.			Introduction and Overview
	8:15 a.m.			State and Federal Enforcement of Off-label Promotion: What Compliance Lessons can be Drawn from Recent Cases Meredith Manning, Esq. Partner, Hogan & Hartson, LLC; Former Assistant US Attorney, Civil Division, US Attorney's Office; Former Associate Chief Counsel, Food and Drug Administration, Washington, DC Presentation Material (Acrobat) Jeffrey Steger, Esq. Trial Attorney, Office of Consumer Litigation, US Department of Justice, Washington, DC Presentation not provided
	9:15 a.m.			Anti-kickback Settlements John T. Bentivoglio, Esq. Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice, Washington, DC Presentation Material (Acrobat) Jay Darden, Esq. Assistant Chief, Fraud Section, US Department of Justice, Washington, DC
	10:00 a.m.			Break
	10:30 a.m.			FCPA Sandy Merber, Esq. Counsel, International Trade Regulation and Sourcing, General Electric Co., Washington, DC Presentation Material (Acrobat) Hank Bond Walther, Esq. Assistant Chief, Fraud Section, US Department of Justice, Criminal Division, Washington, DC Presentation not provided Peter S. Spivack, Esq. Partner, Hogan & Hartson, Washington, DC Presentation not provided
	11:30 a.m.			Faculty Q&A
	12:00 p.m.			Preconference Adjournment; Lunch on Your Own
	PRECONFERENCE III			INTERNET AND SOCIAL NETWORKING COMMUNICATION
	8:00 a.m.			Introduction and Overview: Challenges for the Pharmaceutical Industry in Internet and Social Networking Marketing Activities Daniel A. Kracov, Esq. Partner and Chair, Arnold & Porter LLC, FDA and Healthcare Practice, Washington, DC (Co chair) Matthew M. Malloy, Esq. Director and Associate General Counsel, The Procter & Gamble Company, Cincinnati, OH (Co chair) Presentation Material (Acrobat)
	8:45 a.m.			The Industry Perspective on the Regulation of the Internet and Social Networking Communications Marketing Jeffrey K. Francer, Esq. Assistant General Counsel, Pharmaceutical Research and Manufacturers Association, Washington, DC Presentation Material (Acrobat) Robert Pineda, Esq. Assistant Counsel, Regulatory, Merck & Co., Inc., North Wales, PA Presentation Material (Acrobat)
	10:00 a.m.			Break
	10:15 a.m.			The Federal Trade Commission's Approach to Internet and Social Networking Marketing Richard L. Cleland Assistant Director, Division of Advertising Practices, Bureau of Consumer Protection, Federal Trade Commission, Washington, DC Presentation Material (Acrobat)
	11:00 a.m.			Faculty Round Table Discussion Based on Hypotheticals: Marketing on the Internet and Social Networking Communications
	12:00 p.m.			Preconference Adjournment; Lunch on Your Own


	DAY I: Recent Government Enforcement Wednesday, November 11, 2009

	1:00 p.m.			Welcome and Introduction Colleen M. Craven Vice President, Corporate Compliance & Business Practices, Endo Pharmaceuticals, Chadds Ford, PA (Co chair)
	1:15 p.m.			Regulator Panel on Transparency and Disclosure Melissa J. Lopes, Esq. Deputy General Counsel, Massachusetts Department of Public Health, Boston, MA George Till, MD State Legislator, Vermont, Jericho, VT Cody Wiberg, PharmD, RPh Executive Director, Minnesota Board of Pharmacy, Minneapolis, MN John Patrick Oroho, Esq. Executive Vice President, Porzio Pharmaceutical Services; Principal, Porzio, Bromberg & Newman PC, Morristown, NJ (Moderator) Discussion Only
	2:15 p.m.			Overview: Pfizer CIA Promotional Monitoring Requirements Lori Alarimo, Esq. Senior Corporate Counsel, Promotional Quality Assurance, Pfizer Inc., New York, NY Edward Nowicki, Esq. Deputy Compliance Officer-Global Programs, Senior Corporate Counsel, Corporate Compliance, Pfizer Inc., New York, NY Presentation Material (Acrobat) John S. Rah Partner, Morgan, Lewis & Bockius LLP, Washington, DC Presentation not provided
	2:45 p.m.			Transition Break


	AFTERNOON TRACK SESSIONS

	AFTERNOON TRACK I			Compliance Program Elements: How to Implement and Enhance a Pharmaceutical Compliance Program to Meet Evolving Regulatory Standards
				This track will teach attendees the "how" of compliance program operations, not just focus on the "what". This track will be particularly useful for attendees who are new to compliance and/or new to the pharmaceutical industry
	3:00 p.m.			How to Structure your Compliance Department Doreen F. Shulman Vice President, Chief Compliance and Ethics Officer, Bristol-Myers Squibb, Princeton, NJ (Co chair) Peter S. Spivack, Esq. Partner, Hogan & Hartson, Washington, DC (Co chair) Jack T. Tanselle Director, Navigant Consulting, Inc., Chicago, IL (Co chair) Presentation Material (Acrobat)
	3:30 p.m.			How to Create and Maintain Procedural Documents Frances T. Germann Director, Procedural Document Governance, Bristol-Myers Squibb, Princeton, NJ Presentation Material (Acrobat)
	4:00 p.m.			How to Deliver Innovative and Effective Compliance Training Jack T. Tanselle Director, Navigant Consulting, Inc., Chicago, IL Mark Williamson Director, Compliance and Ethics Education and Communication, Bristol-Myers Squibb, Princeton, NJ Presentation not provided
	4:30 p.m.			How Program Management Can Keep you on Track Leila A. Daiuto Director, Life Sciences & Healthcare, Axentis, Inc., Cleveland, OH Edward H. Leskauskas Director, Compliance and Ethics Operations and Program Management, Bristol-Myers Squibb, Princeton, NJ Presentation Material (Acrobat)
	5:30 p.m.			Adjournment and Networking Reception

	AFTERNOON TRACK II			An Integrated Approach to Compliance: Addressing Healthcare Fraud and Abuse Compliance Risks Throughout a Product's Lifecycle
				This track will focus on healthcare fraud and abuse compliance risks in the areas of clinical research and development and sales and marketing, including government price reporting, pharmacovigilance and medical information. This track will be particularly useful for seasoned pharmaceutical compliance professionals
	3:00 p.m.			Introduction and Overview John T. Bentivoglio, Esq. Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, Department of Justice, Washington, DC (Co chair) Elizabeth V. Jobes, Esq. Vice President and Chief Compliance Officer, Adolor Corporation; Former Senior Director, Global Compliance Officer, Cephalon; Former Assistant District Attorney, Philadelphia District Attorney's Office, Exton, PA (Co chair) Brian Riewerts Partner, Global Pharmaceuticals and Life Sciences, PricewaterhouseCoopers LLP, Baltimore, MD (Co chair)
	3:15 p.m.			Advanced Issues in Clinical Compliance Colleen Gorman Senior Director, Technical Operations Lead, Pfizer, Inc., New York, NY Anup Kharode Senior Manager, US Pharmaceutical and Life Sciences Advisory, PricewaterhouseCoopers LLP, Formerly Principal Scientist, Clinical Development, GlaxoSmithKline, Philadelphia, PA Presentation Material (Acrobat) Kelly N. "Nikki" Reeves, MPA, JD Partner, King & Spalding LLP, Washington, DC Presentation Material (Acrobat)
	4:00 p.m.			Advanced Issues in Commercial (Sales & Marketing) Compliance Karen Lowney Senior Director of Global Compliance, Cephalon, Former Director of International Compliance, Schering-Plough, Frazer, PA Kathy Tench Manager, Huron Consulting Group, New York, NY Manny Tzavlakis Director, Life Sciences Advisory Services, Huron Consulting Group, New York, NY Presentation Material (Acrobat)
	4:30 p.m.			Advanced Issues in Medical Affairs Compliance Elizabeth V. Jobes, Esq. Vice President and Chief Compliance Officer, Adolor Corporation; Former Senior Director, Global Compliance Officer, Cephalon; Former Assistant District Attorney, Philadelphia District Attorney's Office, Exton, PA Harvey C. Kaish Vice President and Senior Counsel, Bristol-Myers Squibb, Plainsboro, NJ Ann E. Lewis, Esq. Counsel, Ropes and Gray, former Vice-President and Senior Counsel, U.S. Healthcare Law Compliance, Bristol-Myers Squibb, New York, NY Presentation Material (Acrobat)
	5:30 p.m.			Adjournment and Networking Reception

	AFTERNOON TRACK III			Transparency and Third Party Compliance Requirements
				This track will focus on state and federal marketing disclosure laws, clinical trial disclosure laws and vendor access requirements
	3:00 p.m.			Introduction and Overview Eve Costopoulos Vice President, Global Compliance, Schering-Plough Corporation, Kenilworth, NJ (Co chair) Kris Curry Senior Director, Health Care Compliance Operations, Johnson & Johnson Pharmaceutical Research & Development, Titusville, NJ (Co chair) Gregory H. Levine, Esq. Partner, Ropes & Gray, Washington, DC (Co chair) Paul J. Silver Managing Director, Practice Leader, Life Sciences Advisory Services, Huron Consulting Group, Atlanta, GA (Co chair) Presentation Material (Acrobat)
	3:15 p.m.			Sunshine Act: Latest Developments and Industry Impact Albert F. Cacozza, Jr., Esq. Partner, Ropes & Gray LLP; Former Counsel, Subcommittee on Labor, Committee on Labor and Human Resources, United States Senate, Washington, DC Presentation Material (Acrobat) Marina Pearlman Senior Corporate Counsel, Pfizer, New York, NY Presentation Material (Acrobat) Gregory H. Levine, Esq. Partner, Ropes & Gray, Washington, DC (Moderator)
	3:45 p.m.			Disclosure of Clinical Trial Results: Obligations and Best Practices Mark A. DeWyngaert, MBA, PhD Managing Director, Huron Consulting Group, New York, NY Presentation Material (Acrobat) Craig A. Metz, PhD Vice President Regulatory Affairs, GlaxoSmithKline, Research Triangle Park, NC Presentation Material (Acrobat)
	4:15 p.m.			Disclosure of Third-Party Data: Compliance and Beyond Anthony Brennan Director, Policy and Audit Interface, Johnson & Johnson, Titusville, NJ Howard L. Dorfman, Esq. Counsel, Ropes & Gray LLP; Former Chief Legal Officer, Pharmaceutical Division, Bayer Healthcare LLC; Former Counsel, US Medicines Group, Bristol-Myers Squibb, New York, NY Patricia Molino Vice President Public Affairs, Johnson & Johnson Corporate Communications, New Brunswick, NJ Presentation Material (Acrobat) Katie B. Topolewski Senior Counsel, Commercial Business, Corporate Compliance, Endo Pharmaceuticals, Chadds Ford, PA Dave Wysocky Director, Pharmaceutical and Life Sciences Advisory Services, PricewaterhouseCoopers LLP, Lebanon, NJ Kris Curry Senior Director, Health Care Compliance Operations, Johnson & Johnson Pharmaceuticals Groups, Titusville, NJ (Moderator) Presentation Material (Acrobat)
	5:00 p.m.			Third Party Data: How to Collect and Use It Effectively Eve Costopoulos Vice President, Global Compliance, Schering-Plough Corporation, Kenilworth, NJ Debjit A. Ghosh, MS, MPH Managing Director, Huron Consulting Group, New York, NY John Poulin Solutions Architect, Huron Consulting Group, New York, NY Presentation Material (Acrobat)
	5:30 p.m.			Adjournment and Networking Reception

	AFTERNOON TRACK IV			Instituting a Truly Global Compliance Program
				This track will focus on a number of areas that companies operating globally need to make sure they have considered as their compliance organizations mature. This track is for legal counsel and seasoned compliance professionals in global organizations.
	3:00 p.m.			Introduction and Overview Panel: What is a Global Compliance Organization in Practice? Scott Bass, Esq. Partner, Sidley Austin LLP, Washington, DC (Co chair) Presentation Material (Acrobat) Kathleen Meriwether, Esq. Principal, Fraud Investigation & Dispute Services, Ernst & Young LLP; Former Assistant United States Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA (Co chair) Caroline West, Esq. Senior Vice President, Chief Compliance and Risk Officer, Shire Pharmaceuticals, Inc., Wayne, PA (Co chair)
	3:45 p.m.			Panel: Building Promotional and Event Review Processes in an International Environment Keith M. Korenchuk, JD, MPH Partner, Arnold & Porter, Washington, DC Sheila Stranks Senior Director and Deputy Compliance Officer, International, Shire Pharmaceuticals Group plc; Magistrate, Basingstoke Law Courts, Basingstoke, Hampshire, UK Sharon J. White Director, International Compliance Office, Wyeth Pharmaceuticals, Collegeville, PA Kathleen Meriwether, Esq. Principal, Fraud Investigation & Dispute Services, Ernst & Young; Former Assistant United States Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA(Moderator) Presentation Material (Acrobat)
	4:30 p.m.			Safety and Pharmacovigilance Issues Globally Michael Giffin Director of Life Sciences, World Class International, New York, NY Presentation Material (Acrobat)
	5:15 p.m.			Reference Pricing: Staying Ahead of Evolving Regulatory Landscape James C. Stansel, Esq. Partner, Sidley Austin LLP; Former Acting General Counsel, US Department of Health & Human Services, Washington, DC Presentation Material (Acrobat)
	6:00 p.m.			Adjournment and Networking Reception