First EMA workshop on non-animal approaches in support of medicinal product development: challenges and opportunities for use of micro-physiological systems
Date:
05/10/2017
Location:
European Medicines Agency, London, UK
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.
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Agenda - First EMA workshop on non-animal approaches in support of medicinal product development – challenges and opportunities for use of micro-physiological systems (PDF/321.46 KB)
First published: 25/09/2017
Last updated: 25/09/2017
EMA/CHMP/SWP/522061/2017 -
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Report - First EMA workshop on non-animal approaches in support of medicinal product development – challenges and opportunities for use of micro-physiological systems (PDF/126.84 KB)
First published: 09/11/2018
EMA/CHMP/SWP/250438/2018 -
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Presentation - Non-animal approaches in support of medicinal product development - setting the scene (S. Beken) (PDF/948.85 KB)
First published: 15/11/2017
Last updated: 15/11/2017 -
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Presentation - Advanced cell models, organs on a chip and microphysiological systems in drug development (A. Roth) (PDF/4.63 MB)
First published: 15/11/2017
Last updated: 15/11/2017 -
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Presentation - Placing microphysiological systems in the pharmaceutical R&D strategy (L. Ewart) (PDF/1.2 MB)
First published: 15/11/2017
Last updated: 15/11/2017 -
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Presentation - MEA assays using human iPSC-derived cardiomyocytes, challenges and opportunities (T. de Korte) (PDF/2.16 MB)
First published: 15/11/2017
Last updated: 15/11/2017 -
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Presentation - MPS – development status, first industrial adoption and current challenges (U. Marx) (PDF/3.74 MB)
First published: 15/11/2017
Last updated: 15/11/2017 -
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Presentation - Populating organs-on-chip with cells derived from human stem cells (C. Mummery) (PDF/30.54 MB)
First published: 15/11/2017
Last updated: 15/11/2017 -
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Presentation - In vitro in vivo extrapolation (IVIVE): why it is not as easy as you may think (A. Rostami) (PDF/7.15 MB)
First published: 15/11/2017
Last updated: 15/11/2017 -
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Presentation - Organ-on-chip networking in Europe (J. van den Eijnden-van Raaij) (PDF/1.2 MB)
First published: 15/11/2017
Last updated: 15/11/2017 -
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Presentation - Determining the predicative ability of in vitro microphysiological systems to answer critical regulatory questions (S. Fitzpatrick) (PDF/870.95 KB)
First published: 15/11/2017
Last updated: 15/11/2017 -
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Presentation - Detection of toxicity to reproduction for human pharmaceuticals (G. Waxenecker) (PDF/801.86 KB)
First published: 15/11/2017
Last updated: 15/11/2017