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. 2013 Feb 27;2(2):e31.
doi: 10.1038/psp.2013.7.

The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop

E Manolis  1 , S Rohou, R Hemmings, T Salmonson, M Karlsson, P A Milligan
Affiliations

The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop

E Manolis et al. CPT Pharmacometrics Syst Pharmacol. .

Abstract

The European Medicines Agency (EMA) and the Federation of Pharmaceutical Industries and Associations (EFPIA) hosted a workshop on modeling and simulation (M&S).(1) Representatives from industry, academia, and regulatory agencies from Europe and beyond discussed the role of M&S in the development and registration of medicinal products within plenary and breakout sessions (BOS). This manuscript summarizes the plenary discussion (Table 1) focusing on the European perspective. Deliverables from each BOS are included in separate papers.CPT: Pharmacometrics & Systems Pharmacology (2013) 2, e31; doi:10.1038/psp.2013.7; advance online publication 27 February 2013.

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Figures

Figure 1
Figure 1
Framework for M&S in regulatory review according to impact on regulatory decision. M&S, modeling and simulation.
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