EMA and EFPIA debate modelling

Modelling and simulation methodology provides an opportunity to improve the efficiency of pharmaceutical development, as well as to facilitate the regulatory assessment of medicines, according to participants of a workshop held at the European Medicines Agency.

The workshop, hosted jointly by the European Medicines Agency and the trade group European Federation of Pharmaceutical Industries and Associations (IFPMA), brought together key opinion leaders and regulatory experts from Europe and beyond to discuss the role of modelling and simulation in areas such as early medicine development, dose finding, clinical pharmacology, studying special populations, and the optimization and analysis of pivotal clinical trials.

Modelling and simulation are techniques that use mathematical models to understand and predict the outcomes of interventions. They are used widely in engineering and science, including the development of medicines, and can be used to improve the efficiency of the design and development of products.