The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop. (27th February 2013)

• Record Type: Journal Article
• Authors: Manolis, E; Rohou, S; Hemmings, R; Salmonson, T; Karlsson, M; Milligan, PA
• Is Part Of: CPT: pharmacometrics & systems pharmacology. Volume 2:Number 2(2013)
• Page Start: 1
• Page End: 4
• Publication Date: 2013-02-27
• Subjects: Pharmacokinetics -- Periodicals; Pharmacology -- Periodicals; Pharmacokinetics; Periodicals; 615.05
• DOI: 10.1038/psp.2013.7
• Languages: English
• ISSNs: 2163-8306

Abstract

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