BioSim EU Network of Excellence together with 3 of its member organisations Simcyp Limited, CBG-MEB, and University of Sheffield announce two separate workshops on “Concepts” & “Applications” of Modelling & Simulation in ADME targeted for scientists from EU Regulatory Agencies. This conforms to the BioSim mission of propagating M&S knowledge using funds from the European Framework 6 Program. Participants from EU Regulatory Agencies will receive free registration to the courses (courtesy of Simcyp & University of Sheffield) and travel assistance (provided
by BioSim).

Description of the Courses:
• Concepts: 24th-25th September
• Applications: 27th-28th September

Modelling and Simulation (M&S) is used increasingly to facilitate the process of drug development by informing better study design, identifying selected groups of individuals or conditions that may require special attention, and identifying theoretically conceivable extreme cases which are not amenable to
clinical testing yet are informative regarding labelling issues.

The first workshop will cover issues related to in vitro – in vivo extrapolation (IVIVE) of metabolic clearance (CL), metabolic drug-drug interactions (DDIs), inter-individual variability (due to age, ethnicity, CYP genotypes, and diseases such as renal failure and cirrhosis, etc.).
The second course focuses on dose non-linearity, trial design, assessing oral drug absorption and volume of distribution.

For further information please contact:
Amin Rostami, University of Sheffield (a.rostami@sheffield.ac.uk), Jan Welink, Medicines Evaluation Board
(j.welink@cbg-meb.nl), or Susan Lundie, Simcyp Limited (s.lundie@simcyp.com)