AGAH Discussion Forum in Bonn, November 11, 2019
This year's forum discussed "How to interprete an investigator's brochure for meaningful risk assessment".
Dr. Lutz Wiesner, BfArM and Dr. Plassmann, PCS presented together on the topic: Potential risks for human subjects associated with inadequate non-clinical safety assessment, to provide guidance from both a Regulator's and a Sponsor's perspective on Dos and Don'ts for adequately written IBs. This joint presentation can be downloaded from here, and also from the AGAH-Website at https://www.agah.eu/event/agah-diskussionsforum-2019/
Should you require further information, please don't hesitate to get in touch.
Read/download: Wiesner+Plassmann_AGAH_Diskussionsforum2019_IB-meaningful risk assessment_Fv1.0 (website).pdf