TL54: Safety Evaluation: When, What, How?
*Aloka G Chakravarty, US FDA 

Keywords: safety, meta-analysis, best practices

This roundtable will talk about strategies for quantitative safety evaluation of drugs and therapeutic biologics. Issues and best practices related to focused safety evaluation will be discussed. Pre-planning for safety evaluation, considerations for a complete data submission, early discussion with the FDA and meta-analytic considerations will be discussed, along with case examples.