Transforming the field of pharmaceutical risk management, the Food and Drug Administration Amendments Act of 2007 (FDAAA) granted the U.S. Food and Drug Administration (FDA) the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from a manufacturer to ensure that the benefits of a drug or biological product outweigh the risks.
As the U.S. healthcare system continues to undergo a transformation, we find ourselves at a critical inflection point for investment in pharmaceutical innovation.
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Transforming the field of pharmaceutical risk management, the Food and Drug Administration Amendments Act of 2007 (FDAAA) granted the U.S. Food and Drug Administration (FDA) the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from a manufacturer to ensure that the benefits of a drug or biological product outweigh the risks.
