Experts and regulators discuss role of modelling and simulation in medicine development and regulatory assessment
News
Participants at a workshop held at the European Medicines Agency have 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 workshop, hosted jointly by the European Medicines Agency and the European Federation of Pharmaceutical Industries and Associations, 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.
The attendees at the workshop agreed that enhanced communication between the pharmaceutical industry, academia and regulators from the early stages of medicine development and the sharing of data, models and qualification procedures could overcome some of the current gaps in modelling and simulation methodology.
They also agreed that the workshop set the scene for further dialogue, working towards greater integration of modelling and simulation in the development and regulatory assessment of medicines.
The slides and agenda from the workshop are already available on this website. A report summarising the outcomes of the workshop, together with updated slide sets, will be available shortly.