Ninth Annual PharmaCongress: Agenda: Preconference Symposia

	Preconference Symposia - Monday, October 27, 2008

	7:00 a.m.			Congress Registration
	8:00 a.m.			Preconferences Commence; Choose one
	Preconference I			Pharmaceutical Regulatory and Compliance Basics
	8:00 a.m.			Welcome and Introduction Kelly B. Freeman, PhD Director, US Affiliate, Compliance and Ethics, Eli Lilly and Company, Indianapolis, IN (Co chair) Janet L. "Lucy" Rose National Managing Director, Life Sciences Regulatory & Capital Markets Consulting, Deloitte & Touche LLP, Former Director, Division of Drug Marketing, Advertising, and Communications (DDMAC), Former Director, Office of Training and Communications, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, Washington, DC (Co chair)
	8:15 a.m.			Compliance Overview: Laws and Regulations, the OIG Compliance Program Guidance for Pharmaceutical Manufacturers, the Federal Sentencing Guidelines, and Important Settlements with the Government Retta M. Riordan, Esq. Principal, Riordan Consulting LLC, Former Business Ethics and Compliance Officer, Organon USA Inc., Westfield, NJ Presentation Material (Acrobat) Presentation Material (Powerpoint)
	9:00 a.m.			FDA Regulatory Overview: Trends Affecting the Regulation of Advertising and Promotion, the FDA Review Process and Requirements for Claim Support, Fair Balance, and DTC Promotion Janet L. "Lucy" Rose National Managing Director, Life Sciences Regulatory & Capital Markets Consulting, Deloitte & Touche LLP, Former Director, Division of Drug Marketing, Advertising, and Communications (DDMAC), Former Director, Office of Training and Communications, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, Washington, DC Permission not given to post
	10:00 a.m.			Break
	10:15 a.m.			Implementing the Seven Elements of a Compliance Program: Practical Advice and Best Practices for Policy Development, Training, Communications, Monitoring, Auditing, and Corrective Actions Kelly B. Freeman, PhD Director, US Affiliate, Compliance and Ethics, Eli Lilly and Company, Indianapolis, IN Presentation Material (Acrobat) Presentation Material (Powerpoint)
	11:15 a.m.			Comments and Questions
	12:00 p.m.			Preconference Adjournment; Lunch on your Own
	Preconference II			State Marketing, Ethics and Disclosure Laws and Federal Preemption
	8:00 a.m.			Welcome and Introduction Janice G. Cunningham, Esq. Healthcare Compliance Officer and Corporate Counsel, Barrier Therapeutics Inc., Princeton, NJ (Co chair) Jeffrey L. Handwerker, Esq. Partner, Arnold & Porter, Washington, DC (Co chair)
	8:15 a.m.			State of the States: What's the Current Landscape regarding Aggregate Spend/Disclosure Laws, Gift Bans, Certification/Declaration Laws, Licensure/Registration, Prescriber Data Laws and Clinical Trial Registries? Janice G. Cunningham, Esq. Healthcare Compliance Officer and Corporate Counsel, Barrier Therapeutics Inc., Princeton, NJ Jeffrey L. Handwerker, Esq. Partner, Arnold & Porter, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint)
	9:00 a.m.			What's on the Horizon? Licensure Concerns for Pharma Companies David W. Ogden, Esq. Partner and Co chair, Government and Regulatory Litigation Practice Group, Wilmer Hale, Former Assistant Attorney General, Civil Division, US Department of Justice, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint)
	9:30 a.m.			Break
	9:45 a.m.			Federal Preemption: What Makes a Federal Law Able to Trump State Law? What's the Impact of Preemption Litigation on Prescriber Data Laws? Jeffrey L. Handwerker, Esq. Partner, Arnold & Porter, Washington, DC Robert N. Weiner, Esq. Partner, Arnold & Porter, Former Senior Counsel, White House Counsel's Office, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) Handout Material (Acrobat)
	10:30 a.m.			The Federal Sunshine Act Ann Leopold Kaplan, Esq. Assistant General Counsel, PhRMA, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint)
	11:00 a.m.			Panel Discussion: Revised PhRMA Code: What's Changed and What's the Impact on State Laws? State AG Perspective: Where is the Focus for the Coming Year? What are Advocacy Groups Doing? John T. Bentivoglio, Esq. Partner, King & Spalding LLP, Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, Department of Justice, Washington, DC
	11:30 a.m.			Questions and Answers
	12:00 p.m.			Adjournment and Lunch on Your Own
	Preconference III			Auditing, Monitoring and Effective Internal Investigations
	8:00 a.m.			Welcome and Introduction Wendy C. Goldstein, Esq., Partner and Chair, Pharmaceutical Industry Health, Regulatory Practice Group, Epstein Becker & Green, New York, NY (Co chair) Tracy Mastro Director, Life Sciences Advisory Services, Huron Consulting Group, Washington, DC (Co chair) Jonathan Williams, Esq. Director, Health Care Compliance, Genentech, Inc. San Francisco, CA (Co chair)
	8:15 a.m.			Case Study: Implementing a Compliance Monitoring Program - How do you get Started? How do you Know if it's Really Effective? What are Some Useful Tools? Tracy Mastro Director, Life Sciences Advisory Services, Huron Consulting Group, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) Chris Santarcangelo Assistant Director, Corporate Compliance, Purdue Pharma LP, Stamford, CT Jonathan Williams, Esq. Director, Health Care Compliance, Genentech, Inc., San Francisco, CA
	9:30 a.m.			Break
	9:45 a.m.			Identifying and Responding to Potential Violations: An Interactive Discussion of the Stages of an Internal Investigation and Better Practices for Conducting Effective Reviews David Anderson Healthcare Compliance Office Internal Investigator, Genentech, South San Francisco, CA Dan Dovdavany, Esq. Senior Corporate Counsel, US Litigation and Investigations, sanofi-aventis, Bridgewater, NJ Wendy C. Goldstein, Esq. Partner and Chair, Pharmaceutical Industry Health, Regulatory Practice Group, Epstein Becker & Green, New York, NY Presentation Material (Acrobat) Presentation Material (Powerpoint) Liz Lewis, Esq. Vice President, Deputy General Counsel, Millennium Pharmaceuticals, The Takeda Oncology Company, Cambridge, MA
	11:00 a.m.			Break
	11:15 a.m.			Implementation of a Corrective Action Plan Liz Lewis, Esq. Vice President, Duputy General Counsel, Millennium Pharmaceuticals, The Takeda Oncology Company, Cambridge, MA Karen Lowney Senior Director, Global Compliance, Cephalon, Frazer, PA Wendy C. Goldstein, Esq. Partner and Chair, Pharmaceutical Industry Health, Regulatory Practice Group, Epstein Becker & Green, New York, NY (Moderator) Presentation Material (Acrobat) Presentation Material (Powerpoint)
	11:45 a.m.			Comments, Questions and Answers
	12:00 p.m.			Adjournment and Lunch on Your Own
	Preconference IV			Dangerous Documents: Finding Land Mines In Your FDA Records and Emails
	8:00 a.m.			Guidant, Merck, Bayer, Eli Lilly, and American Home Products were sued. During discovery, they were forced to produce their employees' emails and other documents that they thought were confidential. These documents contained inflammatory statements that embarrassed the companies. They had to enter into expensive settlements. If your employees haven't been trained on how to write complete, accurate emails and documents that show the depth of your corporate culture of compliance, your firm could be subject to a similar costly result. This preconference provides actual examples and practical advice about how to avoid problems before they occur, and correct mistakes before they happen. Using actual case studies the preconference session explains: How to write informative documents that don't make you a target How to avoid land mines in wording and presentation How documents tell the story of the corporate culture The dangers in not monitoring employees' emails The risks of leaving blanks and using white-out in required records How to distinguish between fact and opinion Why it is crucial to follow a document retention program Nancy Singer, JD President, Compliance-Alliance LLC, Former Special Counsel, AdvaMed, Former Attorney, US Department of Justice, Washington, DC (Co chair) Permission not given to post
	12:00 p.m.			Adjournment and Lunch on Your Own


	Day I: Perspectives on the Pharmaceutical Sector in Changing Times Monday, October 27, 2008

	1:00 p.m.			Welcome and Introduction Lori Queisser Senior Vice President, Global Compliance and Business Practices, Schering-Plough Corporation, Kenilworth, NJ (Co chair)
	1:15 p.m.			Pharmaceutical Compliance: How Far We've Come and Where we Need to Go Lori Queisser Senior Vice President, Global Compliance and Business Practices, Schering-Plough Corporation, Kenilworth, NJ Arjun Rajaratnam, Esq. Vice President & Compliance Officer - US Pharmaceuticals, GlaxoSmithKline, Research Triangle Park, NC Bert Weinstein, Esq. Vice President, Corporate Compliance, Purdue Pharma LP, Stamford, CT
	2:00 p.m.			OIG Update Mary E. Riordan, Esq. Senior Counsel, Office of Counsel to the Inspector General, Office of Inspector General, Department of Health and Human Services, Washington, DC Permission not given to post
	3:00 p.m.			Break
	3:30 p.m.			Prosecutions Update Michael K. Loucks, Esq. First Assistant U.S. Attorney, U.S. Attorney's Office for the District of Massachusetts, Boston, MA Presentation Material (Acrobat) Presentation Material (Powerpoint)
	4:00 p.m.			Department of Justice Update Jamie Ann Yavelberg, Esq. Assistant Director, Commercial Litigation Branch, Civil Division, US Department of Justice, Washington, DC No PowerPoint presentation provided
	4:30 p.m.			The Newly Revised PhRMA Code Diane E. Bieri, Esq. Senior Vice President, General Counsel, Pharmaceutical Research and Manufacturers of America, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) Marc J. Scheineson, Esq. Alston & Bird LLP, Washington, DC
	5:00 p.m.			Adjournment and Meet the Regulator Networking Reception The Pharma Congress Monday network reception will feature an opportunity to meet a number of key Federal and state regulators and Capitol Hill staff specializing in pharmaceutical policy. Thomas E. Costa Vice President, U.S. Pharmaceuticals Compliance & Ethics, Bristol-Myers Squibb, Princeton, NJ (Co chair)