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Sunday, May 16, 2004, Crystal Gateway Marriott,
Arlington, VA |
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A Pre-Meeting Symposium
Prior to the ISPOR 9th Annual International Meeting
Benefit/Risk:
In Search of the Proper
Balance
5:00 PM - 7:00 PM
Sunday, May 16, 2004
Co-Sponsored by
ISPOR and PhRMA Health Outcomes Committee |
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PROGRAM |
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The majority of activity
regarding risk/benefit has centered around the qualification and measurement
of risk and potential system changes in reporting of risk. Important for
consideration in this equation are the adverse health consequences that
result from not using medicines properly, i.e. benefits foregone. In
addition, the FDAMA- mandated Centers for Education and Research in
Therapeutics have conducted and disseminated results from a landmark series
of think tanks on risk in the context of benefit. This session will provide
an overview of the current environment, discuss a pharmaceutical industry
case study and provide one government agency's approach to addressing
benefit/risk. |
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5:00 PM - 5:15 PM |
Introduction
Moderator: Kathleen Gondek PhD, Head,
Global Health Economics & Outcomes Research, Therapeutic Areas, North
America, Bayer Pharmaceuticals, West Haven, CT, USA |
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5:15 PM - 5:45 PM |
Benefit-Risk in the Balance: Where Do We Stand?
Speaker: Hugh Tilson MD, DrPH,
Senior Advisor to the Dean and Chair, National Steering Committee, Centers
for Education and Research on Therapeutics, University of North Carolina,
Chapel Hill, NC, USA
An update on the latest regulatory framework, the emerging strategic plan
from CERTS to improve the nation’s therapeutics and the results from a
landmark series of ThinkTanks on Risk in the context of benefit will be
discussed. |
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5:45 PM - 6:15 PM |
Benefit-Risk
in Perspective
Speaker: Lynn Bosco MD, MPH
Director, Pharmaceutical Studies, Agency for Healthcare Research and
Quality, Rockville, MD, USA
Capturing of both clinically important benefits, as well as risk, is key to
interpreting the value of findings considered in the context of
risk-benefit. There is a tendency, presently, to focus on risk, thus
developing risk management programs. The goal is to broaden the focus to
consider broader patient health status. |
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6:15
PM
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Lessons from Alosetron:
Using PROs to Inform Benefit-Risk Decisions
how can patients' experiences of a disease and its treatment contribute to
the assessment of benefit?
A case study from alosetron will illustrate the use of patient-reported
outcomes to support benefit-risk analysis and decision making.
Speaker: Maria Watson PhD,
Manager, Global Health Outcomes, Glaxo Smith Kline, Research Triangle Park,
NC, USA |
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6:45
PM - 7:00 PM |
Open
Discussion |
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7:00
PM
- 7:30 PM |
Reception
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9th Annual International Meeting Main Page
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