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

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 develop...

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Detalles Bibliográficos
Autores principales: Manolis, E, Rohou, S, Hemmings, R, Salmonson, T, Karlsson, M, Milligan, P A
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group 2013
Materias:
Perspective
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3600760/
https://www.ncbi.nlm.nih.gov/pubmed/23835942
http://dx.doi.org/10.1038/psp.2013.7
Descripción
Sumario: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.

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