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Description
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.
Audience
Contract Research Organizations (CROs), Faculty, Investigators, Research Administrators, Research Staff, Sponsors, Students
Meet the Presenter
Greg Ball, PhD – ASAPprocess
Greg served in the Navy and taught HS math and physics before earning his MS in statistics from Purdue and PhD in biostatistics from the University of Texas. He co-led a company initiative at Merck between Clinical Safety and Statistics to develop and implement the Aggregate Safety Assessment Planning process.
