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Aggregate Safety Assessment Planning and IND Safety Reporting
Thursday, January 30, 2025 at 2:00 p.m. ET
According to the U.S. Food and Drug Administration (FDA), IND safety reporting needs to be supported by ongoing systematic assessment of the product’s safety data from all sources. This webinar examines the Aggregate Safety Assessment Planning (ASAP) process as a mechanism for meeting this guidance. The ASAPlanning document (updated over time), along with its Safety Surveillance Plan (SSP) appendix, provides comprehensive product-level safety assessment planning, which guides the systematic ongoing review of safety data from all completed and continuing clinical trials throughout development.
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