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Pharma Compliance Summit: Pre-Conference
Wednesday, March 30, 2005
Optional Pre-Conference Symposia
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PRECONFERENCE: Pharmaceutical Pricing, Payment and Reimbursement
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9:00 a.m. |
Grant P. Bagley, MD, JD
Partner, Arnold & Porter
Former Director, Coverage and Analysis Group
HCFA Office of Clinical Standards and Quality
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Tim Nugent
Director, Pharmaceutical Advisory Practice
PricewaterhouseCoopers
Florham Park, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
John D. Shakow, Esq.
Counsel, King & Spalding LLP
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
William A. Sarraille, Esq.
Partner, Sidley Austin Brown & Wood
Washington, DC
(Moderator)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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12:00 noon |
Preconference Adjournment
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Pharma Compliance Summit: Conference: Day One
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1:00 p.m. |
Welcome and Introduction
Michael P. Swiatocha
Vice President and SPRI Compliance Officer
Schering-Plough Research Institute
(Summit Co chair)
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1:15 p.m. |
KEYNOTE ADDRESS: Ethical Issues in Clinical Research - Oversight, Consent, Safety and Publication
Arthur L. Caplan, Ph.D.
Director, Center for Bioethics
University of Pennsylvania
Fellow, American Association for the Advancement of Science, The Hastings Center, The College of Physicians of Philadelphia, and The New York Academy of Medicine
Philadelphia, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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2:00 p.m. |
Introduction to
MEDICAL AFFAIRS MINI-SUMMIT
Jody Ann Noon, RN, JD
Principal, National Life Science Regulatory Practice Leader
Deloitte & Touche
New York, NY
(Summit Co chair)
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2:15 p.m. |
Setting the Stage: Medical and Clinical Affairs: The Ten Toughest Compliance Questions
Regina Gore Cavaliere, Esq.
Senior Counsel, Compliance, Americas
Bristol-Myers Squibb
Plainsboro, NJ
Sharon A. Henry, MD
Vice President, Medical Services and External Affairs
Bristol-Myers Squibb
Plainsboro, NJ
Eric Siegel
Chief Compliance Officer, Cephalon
West Chester, PA
John T. Bentivoglio, Esq.
Partner, King & Spalding
Former Special Counsel for Healthcare Fraud
Chief Privacy Officer, United States Department of Justice
Washington, DC
(Moderator)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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3:15 p.m. |
Break
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3:30 p.m. |
Update by the Regulation of Continuing Medical Education
Murray Kopelow MD, MSC, FRCPC
Chief Executive, Accreditation Council for Continuing Medical Education (ACCME)
Chicago, IL
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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4:00 p.m. |
CME and Consultants Compliance Roundtable
Jon D. Leibowitz
Managing Director, M|C Communications (PriMed)
Boston, MA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Sheryl Vacca, CHC
West Coast Life Science and Health Care Regulatory Practice Leader
Deloitte & Touche LLP
Immediate Past President, Health Care Compliance Association
Los Angeles, CA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Paul Kalb, JD, MD
Partner, Sidley, Austin, Brown and Wood
Washington, DC
(Moderator)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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4:45 p.m. |
Update on International Medical Affairs
Stanley Bukofzer, MD
Director and Vice President, Global Medical Affairs
Golbal Research and Development Division
Abbott Laboratories
Abbott Park, IL
Presentation Material (Acrobat)
Alexander Petersen
Engagement Manager
McKinsey & Company
Florham Park, NJ
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5:30 p.m. |
Roundtable on the Future of Medical Affairs
Michael M. Bregger
Global Director, Life Sciences
Deloitte & Touche LLP
Glen Mills, PA
Leonard Jokubaitis, MD
Vice President, Data Generation
Janssen Ortho McNeil Scientific Affairs
Titusville, NJ
Jeffrey M. Rosenbaum
Director, Pharmaceutical Advisory Services Group
PricewaterhouseCoopers LLP
Philadelphia, PA
(Moderator)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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6:30 p.m. |
Adjournment and Opening Networking Reception
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