Pharmaceutical Regulatory and Compliance Congress: Agenda: Preconference Symposia & Day 1

	Monday, November 5, 2012 Preconference Symposia (Optional; Choose one)

	7:30 a.m.			Congress Registration Opens
	8:30 a.m.			Preconferences Commence (Choose one)
	PRECONFERENCE I			COMPLIANCE 101
				Overview of Pharma Compliance Programs Key Laws, Regulations, and Guidance: OIG Compliance Program Guidance for Pharmaceutical Manufacturers Federal Sentencing Guidelines PhRMA Code FDA Regulations Important Settlements with the Government Implementing the Seven Elements of a Compliance Program Practical Advice and Best Practices for Policy Development, Training, Communications, Monitoring, Auditing, and Corrective Actions Sales and Marketing Compliance Med Affairs and Clinical Compliance International Compliance Interactive Group Discussion of Hypothetical Scenarios
	8:30 a.m.			Welcome and Introduction Gary Del Vecchio Executive Director, US Pharmaceutical Compliance and Ethics, Bristol-Myers Squibb Company, Plainsboro, NJ
				Margaret K. Feltz Director, Corporate Compliance, Purdue Pharma LP, Stamford, CT
				Michael Kendall, Esq. Partner and Head, White-Collar Defense Group, McDermott Will & Emery LLP; Former Deputy Associate Attorney General and Counselor, United States Department of Justice; Former Assistant United States Attorney, United States Attorney's Office, District of Massachusetts, Boston, MA
				Janet L. "Lucy" Rose President, Lucy Rose and Associates, LLC; 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
				Kelly B. Freeman, PhD Senior Director, Ethics and Compliance, Eli Lilly and Company, Indianapolis, IN (Co chair) Presentation Material (Acrobat)
	11:30 a.m.			Preconference Adjournment; Lunch on your Own
	PRECONFERENCE II			AUDITING AND MONITORING BOOT CAMP
				Compliance Auditing Best Practices Drivers for Renewed Focus on Compliance Auditing -- Data Collection, Analysis and Reporting, etc. Sample Compliance Auditing Cycle/Approach The Use of Risk Assessments to Guide Audit Planning Compliance Audit Focus Areas -- Where are we seeing the highest risks? Legal Considerations -- When should an audit be privileged, if ever? Compliance Monitoring Best Practices Drivers for Increased Importance of Compliance Monitoring -- CIA's, Commercial, R&D, etc. Types of Monitoring -- Physical, Electronic, Risk-Based Targeting and Scoring Process Legal Considerations Panel/Audience Discussion on Different Approaches, Perspectives and Practices A Look to the Future: What's Needed, What's Wanted, and What Do We Need to Get There in the Next 2-5 Years?
	8:30 a.m.			Welcome and Introduction Lori Alarimo, Esq. Vice President and Deputy Compliance Officer, Allergan, Former Assistant General Counsel, Pfizer, Irvine, CA Presentation Material (Acrobat)
				Diane Bieri, Esq. Partner, Arnold & Porter LLP; Former Executive Vice President and General Counsel, PhRMA, Washington, DC
				Thomas C. Frongillo, Esq. Partner, Head of Litigation (Boston Office) and Co-Chair of the White Collar Criminal Practice, Weil Gotshal & Manges, Boston, MA
				Michael Hercz, Esq. Director, Audit and Enterprise Risk Services, Deloitte & Touche LLP; Former Vice President and Chief Compliance Officer, Victory Pharmaceuticals, Inc., Costa Mesa, CA
				Vickie L. McCormick Vice President, Health Care Compliance, DePuy, Inc.; Chief Compliance Officer, DePuy Orthopaedics, Inc.; Former Chief Compliance Officer, St. Jude Medical, Warsaw, IN
				Jeff Rosenbaum Vice President, Chief Compliance Officer, Vertex Pharmaceuticals; Former Global Head, Ethics & Compliance, Novartis Oncology, Boston, MA
				Lawrence P. Platkin Vice President and Compliance Officer, Bayer Healthcare LLP, Wayne, NJ (Co chair)
				L. Stephan Vincze, JD, LL M, MBA Director, Audit and Enterprise Risk Services, Deloitte & Touche LLP; Former Vice President, Ethics and Compliance Officer/Privacy Officer, TAP Pharmaceutical Products Inc., Boston, MA (Co chair) Presentation Material (Acrobat)
	11:30 a.m.			Preconference Adjournment; Lunch on your Own
	PRECONFERENCE III			A COMPREHENSIVE OVERVIEW OF PHARMA AND MEDICAL DEVICE CORPORATE INTEGRITY AGREEMENTS (CIAS)
				Lessons Learned from the New and Sunsetting CIAs CIA Implementation -- The First 120 Days and Organizational Challenges Key Considerations Relating to the "Evolved" CIA All attendees of this session receive a comprehensive compendium of Pharma and Device CIAs.
	8:30 a.m.			Welcome and Introduction Tracy Mastro, MBA Senior Director, Life Sciences Advisory Services, Huron Consulting Group, Washington, DC
				Paige Slater, PA-C Global CIA Program Director, Corporate Ethics and Compliance, Synthes, Inc., West Chester, PA
				Bert Weinstein, Esq. Vice President, Corporate Compliance, Purdue Pharma LLP; Former Member, PCF Executive Committee, Stamford, CT
				Wendy C. Goldstein, Esq. Partner, Epstein Becker & Green, New York, NY (Co chair)
				Paul J. Silver Practice Leader, Life Sciences Advisory Services, Huron Consulting Group, Atlanta, GA (Co chair) Presentation Material (Acrobat)
	11:30 a.m.			Preconference Adjournment; Lunch on your Own
	PRECONFERENCE IV			THE NEW ERA OF SCRUTINY: FCPA COMPLIANCE IN PHARMA OPERATIONS
				An Overview of Compliance Risks Facing Pharma Companies, Drawn from: Recent FCPA Enforcement Actions Historical Study of Pharma Companies Involved in the Iraq Oil-for-Food Scandal Risk Awareness for Trends in Pharma International Operations Emerging Compensation Issues Emerging Distribution Channel Issues Managing and Prioritizing Risk
	8:30 a.m.			Welcome and Introduction Jonathan Marks, CPA, CFF, CITP, CFE National Fraud, Ethics & Anti-Corruption Services Leader, Crowe Horwath, New York, NY
				Gregory Paw, Esq. Partner, Pepper Hamilton LLP; Former Director, Division of Criminal Justice, Office of the New Jersey Attorney General; Former Deputy US Attorney, Eastern District of Pennsylvania; Former Deputy Chief, Regime Crimes Liaison Office in Iraq, Philadelphia, PA
				John Roberts Senior Manager, Deloitte Forensics, Philadelphia, PA
				R.J. Saturno Harsco Corporation, Harrisburg, PA
	11:30 a.m.			Preconference Adjournment; Lunch on your Own


	DAY I Monday, November 5, 2012

	12:00 p.m.			Meet and Greet in Exhibit Hall
	1:00 p.m.			Welcome and Introduction Kelly B. Freeman, PhD Senior Director, Ethics and Compliance, Eli Lilly and Company; Executive Committee Member, Pharmaceutical Compliance Forum, Indianapolis, IN (Co chair)
				Michael L. Shaw, Esq. Vice President and Compliance Officer, GlaxoSmithKline-North America Pharmaceuticals, Philadelphia, PA (Co chair)

	1:15 p.m.			Keynote Deirdre Connelly President - North America Pharmaceuticals, GlaxoSmithKline; Former President of US Operations, Eli Lilly and Company, Philadelphia, PA

	1:45 p.m.			Keynote: OIG Update Gregory E. Demske, Esq. Chief Counsel to the Inspector General, Office of Inspector General, Department of Health and Human Services, Washington, DC
				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 Presentation Material (Acrobat)

	2:45 p.m.			Keynote: DOJ Criminal Division Update Lanny A. Breuer, Esq. Head, Criminal Division, US Department of Justice; Former Special White House Counsel; Former Assistant District Attorney, New York City, Washington, DC

	3:15 p.m.			Break

	3:45 p.m.			Keynote: Prosecuting Pharma and Device Fraud Carmen M. Ortiz, Esq. United States Attorney, District of Massachusetts, Boston, MA

	4:15 p.m.			AUSA Panel Marilyn May, Esq. Senior Litigation Counsel, US Attorney?s Office, Eastern District of Pennsylvania, United States Department of Justice, Philadelphia, PA
				Maureen Ruane, Esq. Assistant US Attorney and Chief, Health Care and Government Fraud Unit, Criminal Division, United States Attorney's Office, District of New Jersey, Newark, NJ
				Susan Winkler, Esq. Assistant US Attorney, United States Attorney's Office, District of Massachusetts, Boston, MA
				John T. Bentivoglio, Esq. Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice, Washington, DC (Moderator)

	5:00 p.m.			Keynote: FDA-DDMAC Update Thomas W. Abrams, RPh, MBA Director, Office of Prescription Drug Promotion (OPDP), US Food and Drug Administration, Silver Spring, MD Presentation Material (Acrobat)

	5:30 p.m.			Adjournment and Networking Reception