EMA Workshop Focuses on Modelling and Simulation in Drug Development and Regulatory Assessment

Participants at the workshop agreed that modelling and simulation methodology provides an opportunity to improve the efficiency of medicine development, as well as to facilitate the regulatory assessment of medicines.

The European Medicines Agency and the European Federation of Pharmaceutical Industries and Associations jointly hosted a workshop which 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 optimisation 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.

Participants at the workshop agreed tha