Modelling and Simulation Working Group

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The Modelling and Simulation Working Group provides support to the European Medicines Agency’s scientific committees and working parties on modelling and simulation relating to medicines, including the Committee for Medicinal Products for Human Use (CHMP), the Paediatric Committee (PDCO) and the Scientific Advice Working Party (SAWP). It also supports more general methodological discussions and qualification procedures regarding modelling and simulation.

The Group's work is part of the Agency's drive towards greater integration of modelling and simulation in the development and regulatory assessment of medicines. The Agency considers the methodology to be a powerful tool that can provide an opportunity to improve the efficiency of medicine development and facilitate the regulatory assessment of medicines.

Objectives

The MSWG's objectives 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.

Activities

Composition

The MSWG is composed of European experts selected according to their specific expertise.

Members

Below (in alphabetical order of surname) are the current members of the MSWP. The members' declarations of interests are available in the European expert list.

  • Norbert Benda
  • Julie Bertrand
  • Jacob Brogren
  • Susan Cole
  • Aristeidis Dokoumetzidis
  • Kristin Karlsson
  • Essam Kerwash
  • David Khan
  • Frederike Lentz
  • Victor Mangas Sanjuan
  • Flora Musuamba Tshinanu
  • Anna Nordmark
  • Justin Pittaway-Hay
  • Gerard Pons
  • Francesca Serone
  • Ine Skottheim Rusten
  • Johannes Taminiau
  • Juha Vakkilainen
  • Michiel van den Heuvel
  • Gaby Wangorsch
  • Christian Woloch
  • Wei Zhao