Learn about the upcoming new FDA safety requirements
Webinar with Greg Ball
On December 9th, 2022, the FDA proposed to replace its current annual reporting requirement for investigational new drug applications (INDs) with a new requirement: the annual FDA development safety update report (FDA DSUR).
The proposed annual FDA DSUR is intended to be consistent with the format and content of the DSUR that is supported by the ICH.
The proposed annual FDA DSUR regulation, if finalized, would require an annual report that is more comprehensive and informative than the IND annual report currently required under FDA regulations.
- What effect will this have on your day-to-day work?
- What can you do to be prepared for this?
- What chances does this change offer you?
Join our upcoming webinar on January 18th, 2023, at 5pm CET (11am East Coast US) to get answers to these questions.
Greg Ball is one of the most experienced safety statisticians in the industry – will present about the proposed changes and their impact.
Owner and Consultant at ASAP Process Consulting
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. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists at several pharmaceutical companies (including AbbVie and Merck). He co-leads, with Mary Nilsson, the PhUSE Safety Analytics working group. Greg established, with Bill Wang, the ASA Biopharm Safety Monitoring working group and has been pioneering the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group, to advocate for aggregate safety assessments and cross-disciplinary scientific engagement.
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