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Risk management in exploratory medicines development

Dr. Stephanie Plassmann has evaluated the publicly available non-clinical information on the Bial study and presented the results during this AGAH discussion forum held in Bonn.

The aim of this discussion forum was to work on any possible provisions to further improve the safety in phase I studies, based on lessons learned from the Bial study with a focus on pharmacology, toxicology, study designs and the practical impact of integrated protocols. In this context, the Concept Paper on the Revision of the ‘Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products’ (EMEA/CHMP/SWP/28367/07) was discussed. Additionally, the flow of information within a clinical study was a matter of debate.

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