pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress



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PHARMA CONGRESS PRESENTATIONS
Speaker presentations are password protected for 90 days from the start of the Congress. Registrants may log in by clicking here. For further information, email registration@hcconferences.com.

   Monday, October 28, 2013
   Preconference Symposia (Optional; Choose one)






    7:30 a.m.



Congress Registration










    8:30 a.m.



Preconferences Commence (Choose one)




PRECONFERENCE I



COMPLIANCE BASICS




8:30 a.m.




Introduction, Panel Discussion and Q&A

Wendy C. Goldstein, Esq.
Partner, Health Care and Life Sciences, Regulatory Practice, Cooley, LLP, New York, NY






Retta M. Riordan, JD
President, Riordan Compliance LLC; Former Business Ethics and Compliance Officer, Organon Biosciences, Apex, NC






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






Sue Egan
Director and Principal Consultant, Sue Egan Associates; Former Vice President Compliance, AstraZeneca, Great Missenden, Buckinghamshire, UK (Moderator)










12:00 p.m.




Preconference Adjournment; Lunch on your Own



PRECONFERENCE II



AUDITING AND MONITORING BOOT CAMP




8:30 a.m.




Welcome and Introduction

Paul Silver
Practice Leader and Managing Director, Huron Consulting Group, Atlanta, GA










8:45 a.m.




Conducting Impact and Maturity Risk Assessments to Prioritize Areas for Auditing and Monitoring

Mark Scallon
Partner, Polaris, San Francisco, CA










9:30 a.m.




How to Implement a Monitoring Program to Increase Business Value

Ronald Cook
Compliance Program Manager, EMD Serono, Boston, MA






Lori Greene
Manager, Huron Consulting Group, Atlanta, GA






David M. Stollman
Corporate Compliance Officer, Incyte, Wilmington, DE






Jay Patel
Manager, Huron Consulting Group, Atlanta, GA










10:15 a.m.



Break










10:30 a.m.




Planning and Executing an Effective Records Review

Elaina Filauro
Associate, Huron Consulting Group, New York, NY






Tracy Mastro
Senior Director, Huron Consulting Group, Washington DC










11:15 a.m.




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






Leanne DiDomenico, MA
Manager, Huron Consulting Group, Philadelphia, PA






Rashad Kirby
Compliance Senior Manager, Endo Pharmaceuticals, Malvern, PA






Susan Williamson
Compliance Officer, Endo Health Solutions Inc., Malvern, PA










12:00 p.m.




Preconference Adjournment; Lunch on your Own



PRECONFERENCE III



ETHICAL DECISION MAKING WORKSHOP







  • Introduction of basic concepts of Values Based Leadership and the ethical lenses
  • Values Based Leadership: Tasks of Leadership
  • Ethics: Understanding and broadening our own view
  • Integration of Values Based Leadership within the Ethics/Values of your organization



8:30 a.m.




Introduction, Panel Discussion and Q&A

Jan Byars, PhD
Founder and President, LeadSync, LLC; Co-Chair, Ethics Forum Learning Community, Indianapolis, IN






Paula J. Presnoples, MPA, SPHR
Consultant, LeadSync, LLC, Indianapolis, OH










12:00 p.m.




Preconference Adjournment; Lunch on your Own



PRECONFERENCE IV



CHIEF COMPLIANCE OFFICER (OR DESIGNEE) SUMMIT (No charge; Invitation Only)






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



10:00 a.m.




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)






Margaret K. Feltz, Esq.
Director, Corporate Compliance, Purdue Pharma LP; Member, PCF Executive Committee, Stamford, CT (Co chair)






Kelly B. Freeman, PhD
Senior Director, Ethics and Compliance, Eli Lilly and Company; Member, PCF Executive Committee, Indianapolis, IN (Co chair)






Elizabeth V. Jobes, Esq.
Senior Vice President, Chief Compliance Officer, Auxilium Pharmaceuticals Inc.; Member, PCF Executive Committee, Philadelphia, PA (Co chair)










12:00 p.m.




Preconference Adjournment; Lunch on your Own




    DAY I
    Monday, October 28, 2013






12:45 p.m.




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






Elizabeth V. Jobes, Esq.
Senior ice President, Chief Compliance Officer, Auxilium Pharmaceuticals, Inc.; Member, PCF Executive Committee, Philadelphia, PA










1:00 p.m.




Chief Compliance Officer Roundtable

Eve Costopoulos, Esq.
Vice President, Chief Ethics and Compliance Officer, Eisai Inc., Woodcliff Lake, NJ






Anne Nielsen, Esq.
Chief Compliance and Ethics Officer, Bristol-Myers Squibb, New York, NY






Bert Weinstein, Esq.
Vice President, Corporate Compliance, Purdue Pharmaceuticals, Former Vice President and Assistant General Counsel, Merck, Stamford, CT






Caroline West, Esq.
Senior Vice President, Chief Compliance and Risk Officer, Shire Pharmaceuticals, Inc.; Former Vice President, Global Legal Compliance, Aventis, Philadelphia, PA






Thomas M. Gallagher, Esq.
Partner and Chair, White Collar and Corporate Investigations Practice Group, Pepper Hamilton LLP, Philadelphia, PA (Moderator)










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










3:00 p.m.



Break










3:30 p.m.




AUSA Roundtable

Margaret (Peg) Hutchinson, Esq.
Assistant US Attorney and Chief, Civil Division, United States Attorney's Office, Eastern District of Pennsylvania, Philadelphia, PA






Paul Kaufman, Esq.
Assistant US Attorney Chief of Civil Healthcare Fraud, United States Attorney's Office, Eastern District of New York, Brooklyn, NY






Richard Robinson, Esq.
Section Chief-Major Frauds, Criminal Division, United States Attorney's Office, Central District of California, Los Angeles, CA






Susan Winkler, Esq.
Assistant US Attorney and Chief, Health Care Fraud Unit, 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)










4:30 p.m.




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










5:00 p.m.




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










5:30 p.m.



Adjournment and Networking Reception




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