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Global Regulators to Discuss Benefit-Risk Approaches of Medicinal Products at DIA Workshop
Date:9/30/2009

sk assessment in a regulatory framework, and processes and methods that may enhance regulatory decision making. Session topics will include:
 
  • Ongoing Initiatives to Test Structured Benefit-Risk Assessments
  • Methods for Valuing Risks and Benefits
  • Case Studies of Benefit-Risk Assessment
  • The Place of Models for Benefit-Risk Assessment
  • Processes for Reaching Group Decisions on Benefit-Risk Assessments
  • Characterizing Uncertainty: Grappling with the Unknown
  • Interfacing Benefit-Risk Assessment with Health Technology Assessment and Comparative Effectiveness for the Payor’s Perspective
  • Integrating Benefit-Risk into Early Development of New Products
  • Communicating Benefit-Risk to the End User—Patients
  • Panel Session with representatives from FDA, EMEA, PMDA, Health Canada, academia and patient advocacy groups
Baruch Fischhoff, PhD, Howard Heinz University Professor, Department of Social and Decision Sciences
Carnegie Mellon University; Chair, FDA Risk Communication Advisory Committee, will deliver the keynote address.

Click here to register.

About the Drug Information Association (DIA)
DIA serves more than 30,000 professionals involved in the biopharmaceutical industry and regulatory affairs worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchang
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