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Agenda: Pre-Conference
Sunday, June 6, 2004
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1:00 p.m. - 6:00 p.m. |
OPTIONAL PRECONFERENCE SYMPOSIUM
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A Primer on Regulatory Compliance and Risk Management in Pharmaceutical, Biotechnology and Medical Device Enterprises and the Implications for Business Strategy
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1:00 p.m. |
Welcome and Introduction
Brenton L. Saunders, JD, MBA
Senior Vice President
Global Compliance and Business Practices
Schering-Plough Corporation
Past President, Health Care Compliance Association
Founder, International Association of Privacy Professionals
Kenilworth, NJ
(Preconference Chair)
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1:15 p.m. |
The Evolution of the Compliance Program: From Crisis Manager to Business Enabler
Jonathon Kellerman
Senior Manager, PricewaterhouseCoopers
Philadelphia, PA
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2:00 p.m. |
Getting it Right: Perspectives on Compliance Strategy, Organization and Business Processes
Judith Hazlewood, MBA
Director, Pharmaceutical and Medical Products Practice
McKinsey & Company
Florham Park, NJ
Brian S. Salsberg, JD
Associate Principal, Pharmaceutical and Medical Products Practice
McKinsey & Company
Florham Park, NJ
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2:45 p.m. |
Hot Spots in Pharmaceutical, Biotechnology and Device Regulation and Enforcement: What's Next?
Ethan M. Posner, Esq.
Partner and Chair, Health Care Practice Group
Covington & Burling
Former Deputy Associate Attorney General
Department of Justice
Washington, DC
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3:30 p.m. |
Break
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4:00 p.m. |
Taking a Deeper Dive: Regulatory Issues You Should Really Understand - Federal Regulation of Biomedical Research
Carol Pratt, JD, Ph.D.
Associate, Davis Wright Tremaine LLP
Portland, OR
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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4:30 p.m. |
Taking a Deeper Dive: Regulatory Issues You Should Really Understand - Exchange of Scientific Information and Off-label Promotion
Joan Macaulay, Esq.
Associate, Sidley Austin Brown & Wood
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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5:00 p.m. |
Taking a Deeper Dive: Regulatory Issues You Should Really Understand - Reimbursement and Payment Update
Joseph W. Metro, Esq.
Partner, Reed Smith
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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5:30 p.m. |
Expert Problem Solving Roundtable Preconference Faculty
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6:00 p.m. |
Adjournment
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