There are many ways to do risk assessment, says Elaine Morefield of the FDA during this week's ISPE conference. Failure mode and effects analysis (FMEA) and fishbone diagrams are among them. "Q9 of ICH [the quality risk management guidance of the International Conference on Harmonization] has a good toolbox," she adds. Q9 toolbox
Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes
Wednesday, March 24 | 2pm ET / 11am PT
Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.