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

• Datums:
  Ceturtdiena, 5 Oktobris 2017, Visu dienu
• Atrašanās vieta:
  European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

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

Reference Number: EMA/CHMP/SWP/522061/2017

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

Reference Number: EMA/CHMP/SWP/250438/2018

Presentation - Non-animal approaches in support of medicinal product development - setting the scene (S. Beken)

Presentation - Advanced cell models, organs on a chip and microphysiological systems in drug development (A. Roth)

Presentation - Placing microphysiological systems in the pharmaceutical R&D strategy (L. Ewart)

Presentation - MEA assays using human iPSC-derived cardiomyocytes, challenges and opportunities (T. de Korte)

Presentation - MPS – development status, first industrial adoption and current challenges (U. Marx)

Presentation - Populating organs-on-chip with cells derived from human stem cells (C. Mummery)

Presentation - In vitro in vivo extrapolation (IVIVE): why it is not as easy as you may think (A. Rostami)

Presentation - Organ-on-chip networking in Europe (J. van den Eijnden-van Raaij)

Presentation - Determining the predicative ability of in vitro microphysiological systems to answer critical regulatory questions (S. Fitzpatrick)

Presentation - Detection of toxicity to reproduction for human pharmaceuticals (G. Waxenecker)