Global Regulators to Discuss Benefit-Risk Approaches of Medicinal Products at DIA Workshop

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The Drug Information Association (DIA) and the US Food and Drug Administration (USFDA) will host Assessing Benefits and Risks of Medicinal Products in Regulatory Decisions from November 3- 5, 2009 in Bethesda, MD.

The Drug Information Association (DIA) and the US Food and Drug Administration (USFDA) will host Assessing Benefits and Risks of Medicinal Products in Regulatory Decisions from November 3- 5, 2009 in Bethesda, MD

High-level representatives from FDA, EMEA and Health Canada, along with patient advocates, industry professionals, and academics will explore the evolving world of benefit-risk assessment. Featured regulatory participation will include:

  •     Eric Abadie, MD, European Medicines Agency (EMEA)
  •     Janet Woodcock, MD, CDER, FDA
  •     Kaoru Misawa, Pharmaceuticals and Medical Devices Agency (PMDA)
  •     Robyn Lim, Health Canada

Participants will learn how scientific approaches applied in other fields can aid in decision analysis, approaches and methods to enhance transparency and communication of benefit-risk decisions, ways to overcome the challenges of implementing exploratory approaches to benefit-risk 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 exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA, USA, and with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China, the Association is led by its volunteer-based Board of Directors and executive management team. For more information, visit http://www.diahome.org or call 215-442-6100.

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