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Read the latest manuscript published by AGAH
Dr. Plassmann co-authored this article which summarises the discussion at the forum hosted by the Association for Applied Human Pharmacology (AGAH e.V.) in November 2019 to critically debate how to interpret and optimise the Investigator’s Brochure (IB) for meaningful risk assessment of early clinical trials. The paper entitled "How to Interpret an Investigator’s Brochure for Meaningful Risk Assessment – Results of an AGAH Discussion Forum" was published online in Therapeutic Innovation & Regulatory Science on February 03, 2021. First author is Dr. Jens Rengelshausen.
At the forum, 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 and further presentations can be downloaded from the AGAH-Website at:
AGAH Diskussion Forum 2019 - AGAH
Read/download: Rengelshausen_et_al-2021-Therapeutic_Innovation_&_Regulatory_Science.pdf