DIA, Maryland
March 26, 2010
Conference Objectives Transmit a general understanding of the content of the draft guidance · Ensure attendees understand how to formally submit comments on the draft guidance to the FDA Docket · Provide solid understanding of adaptive design issues and the contexts for their use that are of greater or lesser concern to FDA. Potential issues include operational bias, design induced bias, necessary multiplicity adjustments, difficulties in result interpretation, and the potential effects of eliminating the time to thoughtfully evaluate data during a drug development program. The FDA will outline types of At the conclusion of this meeting, participants should be able to: · Transmit a general understanding of the content of the draft guidance · Explain how to formally submit comments on the draft guidance to the FDA Docket. · Discuss adaptive design issues and the contexts for their use that are of greater or lesser concern to FDA Professionals involved in: · Biostatistics · Clinical research · Compliance · Data analysis · Quality assurance/Quality control · Regulatory affair
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