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Monday, October 28, 2013 Preconference Symposia (Optional; Choose one) |
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7:30 a.m. |
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Congress Registration |
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8:30 a.m. |
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Preconferences Commence (Choose one) |
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PRECONFERENCE I |
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COMPLIANCE BASICS |
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8:30 a.m. 
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Introduction, Panel Discussion and Q&A Wendy C. Goldstein, Esq. Partner, Health Care and Life Sciences, Regulatory Practice, Cooley, LLP, New York, NY |
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Retta M. Riordan, JD President, Riordan Compliance LLC; Former Business Ethics and Compliance Officer, Organon Biosciences, Apex, NC |
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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 |
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Sue Egan Director and Principal Consultant, Sue Egan Associates; Former Vice President Compliance, AstraZeneca, Great Missenden, Buckinghamshire, UK (Moderator) Presentation Material (Acrobat) |
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12:00 p.m. |
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Preconference Adjournment; Lunch on your Own |
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PRECONFERENCE II |
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AUDITING AND MONITORING BOOT CAMP |
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8:30 a.m. 
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Welcome and Introduction Paul Silver Practice Leader and Managing Director, Huron Consulting Group, Atlanta, GA Presentation Material (Acrobat) |
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8:45 a.m. 
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Conducting Impact and Maturity Risk Assessments to Prioritize Areas for Auditing and Monitoring Mark Scallon Partner, Polaris, San Francisco, CA Presentation Material (Acrobat) |
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9:30 a.m. 
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How to Implement a Monitoring Program to Increase Business Value Ronald Cook Compliance Program Manager, EMD Serono, Boston, MA |
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Lori Greene Manager, Huron Consulting Group, Atlanta, GA |
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David M. Stollman Corporate Compliance Officer, Incyte, Wilmington, DE |
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Jay Patel Manager, Huron Consulting Group, Atlanta, GA Presentation Material (Acrobat) |
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10:15 a.m. |
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Break |
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10:30 a.m. 
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Planning and Executing an Effective Records Review Elaina Filauro Associate, Huron Consulting Group, New York, NY |
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Tracy Mastro Senior Director, Huron Consulting Group, Washington DC Presentation Material (Acrobat) |
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11:15 a.m. 
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Making Change Stick: The Importance of Driving Follow Ups and Results from Monitoring Activities BJ D'Avella, MBA Manager, Huron Consulting Group, New York, NY |
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Leanne DiDomenico, MA Manager, Huron Consulting Group, Philadelphia, PA |
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Rashad Kirby Compliance Senior Manager, Endo Pharmaceuticals, Malvern, PA |
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Susan Williamson Compliance Officer, Endo Health Solutions Inc., Malvern, PA Presentation Material (Acrobat) |
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12:00 p.m. |
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Preconference Adjournment; Lunch on your Own |
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PRECONFERENCE III |
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ETHICAL DECISION MAKING WORKSHOP |
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8:30 a.m. 
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Introduction, Panel Discussion and Q&A Jan Byars, PhD Founder and President, LeadSync, LLC; Co-Chair, Ethics Forum Learning Community, Indianapolis, IN |
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Paula J. Presnoples, MPA, SPHR Consultant, LeadSync, LLC, Indianapolis, OH Presentation Material (Acrobat) |
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12:00 p.m. |
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Preconference Adjournment; Lunch on your Own |
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PRECONFERENCE IV |
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CHIEF COMPLIANCE OFFICER (OR DESIGNEE) SUMMIT (No charge; Invitation Only) |
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Persons interested in attending may contact Kelly B. Freeman, PhD Senior Director, Ethics and Compliance, Eli Lilly and Company at freeman_kelly_b@lilly.com |
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10:00 a.m. 
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Introduction, Panel Discussion and Q&A Gary DelVecchio Executive Director, US Pharmaceutical Compliance and Ethics, Bristol-Myers Squibb Company; Member, PCF Executive Committee, Plainsboro, NJ (Co chair) |
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Margaret K. Feltz, Esq. Director, Corporate Compliance, Purdue Pharma LP; Member, PCF Executive Committee, Stamford, CT (Co chair) |
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Kelly B. Freeman, PhD Senior Director, Ethics and Compliance, Eli Lilly and Company; Member, PCF Executive Committee, Indianapolis, IN (Co chair) |
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Elizabeth V. Jobes, Esq. Senior Vice President, Chief Compliance Officer, Auxilium Pharmaceuticals Inc.; Member, PCF Executive Committee, Philadelphia, PA (Co chair) |
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12:00 p.m. |
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Preconference Adjournment; Lunch on your Own |
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DAY I Monday, October 28, 2013 |
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12:45 p.m. |
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Co-chair's Introduction to Day One Gary DelVecchio Executive Director, US Pharmaceutical Compliance and Ethics, Bristol-Myers Squibb Company; Member PCF Executive Committee, Plainsboro, NJ |
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Elizabeth V. Jobes, Esq. Senior ice President, Chief Compliance Officer, Auxilium Pharmaceuticals, Inc.; Member, PCF Executive Committee, Philadelphia, PA |
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1:00 p.m.  |
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Chief Compliance Officer Roundtable Eve Costopoulos, Esq. Vice President, Chief Ethics and Compliance Officer, Eisai Inc., Woodcliff Lake, NJ |
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Anne Nielsen, Esq. Chief Compliance and Ethics Officer, Bristol-Myers Squibb, New York, NY |
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Bert Weinstein, Esq. Vice President, Corporate Compliance, Purdue Pharmaceuticals, Former Vice President and Assistant General Counsel, Merck, Stamford, CT |
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Caroline West, Esq. Senior Vice President, Chief Compliance and Risk Officer, Shire Pharmaceuticals, Inc.; Former Vice President, Global Legal Compliance, Aventis, Philadelphia, PA |
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Thomas M. Gallagher, Esq. Partner and Chair, White Collar and Corporate Investigations Practice Group, Pepper Hamilton LLP, Philadelphia, PA (Moderator) |
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2:00 p.m.  |
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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 Presentation Material (Acrobat) |
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3:00 p.m. |
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Break |
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3:30 p.m.  |
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AUSA Roundtable Margaret (Peg) Hutchinson, Esq. Assistant US Attorney and Chief, Civil Division, United States Attorney's Office, Eastern District of Pennsylvania, Philadelphia, PA |
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Paul Kaufman, Esq. Assistant US Attorney Chief of Civil Healthcare Fraud, United States Attorney's Office, Eastern District of New York, Brooklyn, NY |
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Richard Robinson, Esq. Section Chief-Major Frauds, Criminal Division, United States Attorney's Office, Central District of California, Los Angeles, CA |
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Susan Winkler, Esq. Assistant US Attorney and Chief, Health Care Fraud Unit, United States Attorney's Office, District of Massachusetts, Boston, MA |
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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) |
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4:30 p.m.  |
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FDA-OPDP Update Thomas W. Abrams, RPh, MBA Director, Division of Drug Marketing, Advertising, and Communications, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, Silver Spring, MD Presentation Material (Acrobat) |
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5:00 p.m.  |
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Keynote Mit Spears, Esq. Executive Vice President and General Counsel, Pharmaceutical Research and Manufacturers of America (PhRMA); Former General Counsel, Federal Trade Commission; Former Principal Deputy Assistant Attorney General, Civil and Environmental and Natural Resources Divisions, United States Department of Justice, Washington, DC |
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5:30 p.m. |
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Adjournment and Networking Reception |
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