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

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TitleFirst EMA workshop on non-animal approaches in support of medicinal product development: challenges and opportunities for use of micro-physiological systems
Date05/10/2017 - 05/10/2017
LocationEuropean Medicines Agency, London, UK
SummaryThe 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.

All documents

Name Language First published Last updated
Agenda - First EMA workshop on non-animal approaches in support of medicinal product development – challenges and opportunities for use of micro-physiological systems (English only) 2017-09-25  
Presentation - Non-animal approaches in support of medicinal product development - setting the scene (S. Beken) (English only) 2017-11-15  
Presentation - Advanced cell models, organs on a chip and microphysiological systems in drug development (A. Roth) (English only) 2017-11-15  
Presentation - Placing microphysiological systems in the pharmaceutical R&D strategy (L. Ewart) (English only) 2017-11-15  
Presentation - MEA assays using human iPSC-derived cardiomyocytes, challenges and opportunities (T. de Korte) (English only) 2017-11-15  
Presentation - MPS – development status, first industrial adoption and current challenges (U. Marx) (English only) 2017-11-15  
Presentation - Populating organs-on-chip with cells derived from human stem cells (C. Mummery) (English only) 2017-11-15  
Presentation - In vitro in vivo extrapolation (IVIVE): why it is not as easy as you may think (A. Rostami) (English only) 2017-11-15  
Presentation - Organ-on-chip networking in Europe (J. van den Eijnden-van Raaij) (English only) 2017-11-15  
Presentation - Determining the predicative ability of in vitro microphysiological systems to answer critical regulatory questions (S. Fitzpatrick) (English only) 2017-11-15  
Presentation - Detection of toxicity to reproduction for human pharmaceuticals (G. Waxenecker) (English only) 2017-11-15  

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SWP-H@ema.europa.eu