Regulatory Science and in silico Trials

Invited Speakers

  • Dr Tina Morrison, US Food and Drug Administration, USA
  • Dr Flora Musuamba, European Medicines Agency (TBC)

Symposium Description

An important application of Virtual Human technology are In-Silico Trials (IST). ISTs should contribute to the three R’s, refinement, reduction, or replacement of pre-clinical and clinical trials. Driven forward by the Virtual Human community, the Food and Drug Administration (FDA) in the US, the European Medical Association (EMA), and the Avicenna Alliance, and with funding through, for example, the European Commission, a number of projects developing and applying ISTs are underway. The challenges they face are multifaceted, ranging from validating the underlying in-silico models of specific pathophysiology or applied virtual populations, via technological and infrastructural demands, to regulatory issues. The goal of this special symposium is to bring together key stake holders in the current development of ISTs, to highlight state-of-the-art developments, to discuss the challenges that ISTs are facing, and to contribute to next steps in successfully applying IST in actual (pre-)clinical settings.

Symposium Co-Chairs

  • Alfons Hoekstra, Assistant Professor, University of Amsterdam
  • Marco Viceconti, Professor of Computational Biomechanics, University of Bologna