The European Medicines Agency’s Modelling and Simulation Working Group (MSWG) has met today for the first time. The Agency has a number of working parties and related groups, which can be consulted by the Agency’s scientific committees on scientific issues relating to their particular field of expertise. The Agency is working for a greater integration of modelling and simulation in the development and regulatory assessment of medicines. It considers that the methodology is a powerful tool which could provide an opportunity to improve the efficiency of medicine development, and also could facilitate the regulatory assessment of medicines.
The Agency’s MSWG will meet monthly and provide support to the Agency’s scientific committees and working parties, including the Committee for Medicinal Products for Human Use (CHMP), the Paediatric Committee (PDCO) and the Scientific Advice Working Party (SAWP), on product-related issues but also in more general methodological discussions and qualification procedures regarding modelling and simulation.
The composition and objectives of the group are:
- to enhance the collective competence and capacity to provide advice on and assessment of modelling and simulation in marketing authorisation applications and paediatric investigation plans, reducing uncertainty in benefit-risk decisions and improving product labelling;
- to advance early communication and support innovation with industry and academia in areas like first-in-man or dose-finding trials, study optimisation, disease progression and extrapolation where modelling and simulation can play an important role;
- to develop and communicate standards for the design, conduct, analysis and reporting of modelling and simulation according to the level of regulatory impact, with particular emphasis on those of high regulatory impact such as extrapolation to paediatric and elderly populations;
- to increase awareness and excellence regarding modelling and simulation approaches across the European national authorities.
- The MSWG will elect its chair and adopt a mandate and work plan over the next few meetings.