This public workshop, convened under a cooperative agreement with the Food and Drug Administration, is being held in response to public comments received on the draft guidance “Safety Assessment for IND Safety Reporting” issued in December 2015 requesting a public meeting to discuss the draft guidance and its implications. Broadly, this workshop will provide an opportunity for the stakeholder community to continue discussions around key challenges related to IND reporting practices proposed in the guidance. Sessions will highlight industry experience implementing these approaches, and discussion topics will include but not limited to safety assessment and aggregate analysis, as well as potential best practices for unblinding of data and trial integrity, identifying expected/anticipated events, and determining reporting thresholds.

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