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

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.

Horsham, PA (Vocus) September 30, 2009 -- 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-ri
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Global Regulators to Discuss Benefit-Risk Approaches of Medicinal Products at DIA Workshop
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