CDER SBIA Webinar - Draft Guidance for Industry on Safety Assessment for IND Safety Reporting
On February 1, 2016, 1:30 PM EST, CDER will host a LIVE webinar titled:
This one hour webinar will:
- Provide recommendations for how sponsors of INDs can identify and evaluate important safety information that must be submitted to FDA and all participating investigators under the IND safety reporting regulations at 21 CFR 312.32.
- Discuss the draft guidance recommendations for a systematic approach to IND safety reporting, including the composition and role of a safety assessment committee, aggregate analyses for comparison of adverse event rates across treatment groups, planned unblinding of safety data, reporting thresholds for IND safety reporting, and the development of a safety surveillance plan.
Our featured speaker will be:
Robert Temple, M.D.,
Deputy Center Director for Clinical Science
Center for Drug Evaluation and Research (CDER)