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Benefit-Risk Assessment from Inception to Maturation: Aligning Regulatory and Industry Goals
Mon 10th Feb 2014 - Tue 11th Feb 2014 Open dates in Symplur Signals

Join FDA, EMA, Health Canada, and other regulatory agencies plus patient, payor, industry, and academic representatives to discuss the progress and application of Benefit-risk assessment throughout the development and post-approval life cycle. The meeting will feature discussion of emerging sponsor and regulator expectations for Benefit-risk assessment during development; practical methods commonly used to characterize benefits, risks, and their balance in the peri-approval period; and communicating complex assessments transparently across the development life cycle.

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