Eighth Annual PharmaCongress: Agenda: Preconference Symposia

	Preconference Symposia - Wednesday, November 7, 2007

	7:00 a.m.			Congress Registration
	8:30 a.m.			Preconferences Commence; Choose one only
	Preconference I			Compliance Program Basics: Monitoring, Auditing, Training
				(Session will be interactive and participants will receive a toolkit at the end of this session with Compliance Program basics for training, monitoring and auditing.) Colleen Craven, Vice President, Ethics and Corporate Compliance, Endo Pharmaceuticals, Chadds Ford, PA (Co chair) Wendy C. Goldstein, Esq., Member of the Firm, Epstein Becker & Green, New York, NY (Co chair) Presentation Material (Acrobat) Presentation Material (Powerpoint)
	8:00 a.m.			Overview: Why Training, Monitoring and Auditing are the Critical Components of an Effective Compliance Program
	8:45 a.m.			Training: OIG Compliance Program Guidance for Pharmaceutical Manufacturers; Establishing a Training Curriculum; Types of Training; and Keeping Training Relevant
	9:30 a.m.			Monitoring: OIG Compliance Program Guidance for Pharmaceutical Manufacturers; Using Corporate Integrity Agreements and Other Sources to Establish a Monitoring Plan Based on Your Company's Risks; Considerations for Investigating Findings and How to Conduct such an Investigation; and Evaluation of Necessary Corrective Action (e.g., Training, Communication, Policy Enhancements)
	10:15 a.m.			Break
	10:45 a.m.			Auditing: OIG Compliance Program Guidance for Pharmaceutical Manufacturers; Using Corporate Integrity Agreements and Other Sources to Establish an Audit Plan Based on Your Company's Risks; Establishing an Audit Plan; and Conducting Audits and Discussion of Relevant Considerations (e.g., Communication Plans, Privilege Considerations, Reporting Findings, Investigating Findings, Corrective Action)
	11:30 a.m.			Comments, Questions and Answers
	12:00 p.m.			Adjournment and Lunch on Your Own
	Preconference II			Payment/Reimbursement/Reporting Update
	8:00 a.m.			Introductory Comments William A. Sarraille, Esq., Partner, Sidley Austin LLP, Washington, DC (Co chair) Sue Seferian, Esq., Senior Counsel, Johnson & Johnson, New Brunswick, NJ (Co chair)
	8:05 a.m.			A Short History of Pricing Related Fraud and Abuse Issues Joseph W. Metro, Esq., Partner, Reed Smith LLP, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint)
	8:50 a.m.			Recent Pricing Fraud and Abuse Litigation Developments - Some Perspective on the Boston AWP Case and the FDB Settlement Benjamin J. Keith, Associate, Sidley Austin LLP, Chicago, IL Richard D. Raskin, Esq., Partner, Sidley Austin LLP, Chicago, IL Presentation Material (Acrobat) Presentation Material (Powerpoint)
	9:40 a.m.			Fraud and Abuse Issues in Part D Pricing and Contracting Marci Handler, Esq., Member of the Firm, Epstein Becker & Green, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint)
	10:10 a.m.			Break
	10:25 a.m.			Recent Pricing and Coverage Issues and Their Fraud and Abuse Implications - The Final AMP and Best Price Rule; The OPPS Rule for 2008; The Physician Fee Schedule for 2008; Clinical Trial Coverage under the Medicare Program; and The Pending CHAMP Legislation, including Proposed Changes to Part D Coverage Stephanie P. Gilson, Esq., Johnson & Johnson, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) Ann Leopold Kaplan, Esq., Assistant General Counsel, PhRMA, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) Jayson Slotnik, Esq., Associate, Hogan & Hartson, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) William A. Sarraille, Esq., Partner, Sidley Austin LLP, Washington, DC (Moderator) Presentation Material (Acrobat) Presentation Material (Powerpoint)
	12:00 p.m.			Adjournment and Lunch on Your Own
	Preconference III			Global Compliance Update
				Ted Acosta, Esq., Principal, Ernst & Young LLP, New York, NY (Co chair) Sujata T. Dayal, Esq., Ethics and Compliance Officer, Pharmaceutical Products Group, Abbott Laboratories, Abbott Park, IL (Co chair) Andrew Hayward, Esq., Senior Counsel, AstraZeneca, London, UK Presentation Material (Acrobat) Presentation Material (Powerpoint)
	8:00 a.m.			Organizing and Operating a Global Compliance Program - Resources, Reporting, Scope, International Codes and Local Standards
	8:45 a.m.			Rolling Out Policies, Training and Compliance Guidance in the Global Setting
	9:30 a.m.			Key Issues in Global Compliance - Relationships with Physicians/Customers, CME, Donations, Post-Market, Third-Party Arrangements
	10:15 a.m.			Break
	10:45 a.m.			Incorporating FCPA Compliance into Program Operations
	11:30 a.m.			Comments, Questions and Answers
	12:00 p.m.			Adjournment and Lunch on Your Own
	Preconference IV			Risk Avoidance Writing for Pharmaceutical Companies: Secrets for Avoiding Liability and Creating Accurate, Powerful Documents in Regulated Industries
	8:00 a.m.			In this interactive session, attendees will learn: 4 types of information never to include in documents 7 ways poorly written documents can come back to haunt you 6 tips for grabbing your reader's attention 10 techniques for keeping your reader's eyes glued to the page 5 tricks to improve your proofreading skills by 95% 9 grammatical secrets to avoid errors that even educated people make. Plus...take home 4 Bonus items: Memo Template for requests to management that will save hours of time Email Template to ensure your emails get read and acted upon Proofreading Handout with tips and symbols to share at work Grammar Cheat-Sheet for easy, confident reference Linda Rivero, President, Voice of Persuasion, Alexandria, VA Nancy Singer, President of Compliance-Alliance; Former Prosecutor, U.S. Department of Justice, Washington, DC
	12:00 p.m.			Adjournment and Lunch on Your Own


	Day I: Perspectives on the Pharmaceutical Sector in Changing Times Wednesday, November 7, 2007

	1:00 p.m.			Welcome and Annual State of the Pharmaceutical Compliance Enterprise Address Lori Queisser Senior Vice President, Global Compliance and Business Practices Schering-Plough Corporation Kenilworth, NJ (Co chair)
	1:30 p.m.			The Regulatory Craft: Controlling Risks, Solving Problems, and Managing Compliance Malcolm Sparrow, MPA, PhD Professor of Practice of Public Management and Faculty Chair Executive Program on Strategic Management of Regulatory and Enforcement Agencies Kennedy School of Government, Harvard University Author, The Regulatory Craft: Controlling Risks, Solving Problems, and Managing Compliance and License to Steal: How Fraud Bleeds America's Health Care System Cambridge, MA Presentation Material (Acrobat) Presentation Material (Powerpoint) Handout Material (Acrobat)
	2:15 p.m.			How Big Pharma Should Change Peter Lurie, MD, MPH Deputy Director Public Citizen's Health Research Group Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) Handout Material (Acrobat) Handout Material (Microsoft Word)
	3:00 p.m.			Break
	3:30 p.m.			OIG Update Lewis Morris, Esq. Chief Counsel, Office of Inspector General Department of Health and Human Services Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint)
	4:30 p.m.			The Role of States in Regulating the Pharmaceutical Enterprise James G. Sheehan, Esq. Medicaid Inspector General, State of New York Former Associate United States Attorney, U.S. Attorney's Office Eastern District of Pennsylvania Albany, NY Presentation Material (Acrobat) Presentation Material (Powerpoint)
	5:15 p.m.			State Attorney General Roundtable Jim Donahue, Esq. Pennsylvania Chief Deputy Attorney General, Antitrust Pennsylvania Office of the Attorney General Harrisburg, PA Presentation Material (Acrobat) Presentation Material (Powerpoint) John Guthrie, Esq. Director, Medicaid Fraud Control Unit Ohio Office of Attorney General Columbus, OH David Hart, Esq. Assistant Attorney General, Consumer Protection Oregon Office of the Attorney General Salem, OR John Krayniak, Esq. Assistant Attorney General and Senior Counsel Medicaid Fraud Control Unit New Jersey Office of the Attorney General Trenton, NJ Pat Lupinetti, Esq. (Invited) Assistant Attorney General, Medicaid Fraud Control Unit New York Office of Attorney General Albany, NY Susan J. Miller Managing Attorney, Antitrust & Civil Medicaid Fraud Division Texas Office of the Attorney General Austin, TX Kathleen M. Boozang, Esq. Associate Dean and Professor of Law Cofounder, Health Law & Policy Program and Health Law, Science and Technology Graduate Programs Seton Hall University School of Law Newark, NJ (Moderator)
	6:30 p.m.			Adjournment and Meet the Regulators Networking Reception The Pharma Congress Wednesday networking reception will offer an opportunity to meet a number of key federal and state regulators and Capitol Hill staff specializing in pharmaceutical policy.