First EMA workshop on non-animal approaches in support of medicinal product development: challenges and opportunities for use of micro-physiological systems

The workshop aims to map the current state-of-science in the field of non-clinical development of medicines, develop a common understanding of the benefits and limits of these methods, identify gaps in non-clinical safety testing and stimulate research using these methods to address these gaps and encourage use in regulatory testing. The workshop will also encourage dialogue between developers, users and regulators and to facilitate the regulatory acceptance of innovative non-animal methods for a defined context of use for the approval of safe medicines while promoting the 3Rs (replacement, reduction and refinement principles.