Committee for Advanced Therapies (CAT) and the German Society for Transfusion Medicine and Immunohaematology (DGTI) workshop on advanced-therapy medicinal products: How to bring cell-based medicinal products successfully to the market
The workshop is co-organised by the European Medicines Agency's (EMA's) Committee for Advanced Therapies (CAT) and the German Society for Transfusion Medicine and Immunohaematology (DGTI) in collaboration with the German Stem Cell Network (GSCN) and aims to strengthen dialogue between CAT and the advanced-therapy-medicinal-product (ATMP) developers in industry, academia and hospitals and to facilitate ATMP development and access to the registration procedure.The workshop will allow for the attendees to learn about the development and authorisation of cell-based ATMPs in the European Union and the role of the CAT; to learn about the support provided by EMA and the CAT to ATMP developers; to understand the criteria that CAT applies for the classification of ATMPs; and to hear about CAT's considerations and recent interactions with experts on cell-based therapies for cardiac repair. It will also allow to interact directly with the Regulators in an open forum discussion.
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Workshop programme - Committee for Advanced Therapies (CAT) and the German Society for Transfusion Medicine and Immunohaematology (DGTI) workshop on advanced-therapy medicinal products: How to bring cell-based medicinal ... (PDF/241.92 KB)
First published: 26/06/2014
Last updated: 26/06/2014 -
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Invitation - Committee for Advanced Therapies (CAT) and the German Society for Transfusion Medicine and Immunohaematology (DGTI) workshop on advanced-therapy medicinal products: How to bring cell-based medicinal products... (PDF/1.11 MB)
First published: 19/05/2014
Last updated: 19/05/2014 -
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Presentation - Challenges during the development of advanced-therapy medicinal products (Paula Salmikangas) (PDF/1.59 MB)
First published: 21/10/2014
Last updated: 21/10/2014 -
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Presentation - Procedures and support to developers (Patrick Celis) (PDF/413.88 KB)
First published: 21/10/2014
Last updated: 21/10/2014 -
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Presentation - Classification of advanced-therapy medicinal products (Egbert Flory) (PDF/182.25 KB)
First published: 21/10/2014
Last updated: 21/10/2014 -
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Presentation - Autologous cell therapies manufactured in the hospital: Advanced-therapy medicinal products or not? (Kenneth K. Kleinhenz) (PDF/4.87 MB)
First published: 21/10/2014
Last updated: 21/10/2014 -
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Presentation - CAT’s views on classification of advanced-therapy medicinal products (Nicolas Ferry) (PDF/1.17 MB)
First published: 21/10/2014
Last updated: 21/10/2014 -
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Presentation - Cell-based therapies for cardiac repair (Martina Schà¼àŸler-Lenz) (PDF/181.13 KB)
First published: 21/10/2014
Last updated: 21/10/2014 -
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Presentation - Quality aspects for cell-based products for cardiac repair (Paula Salmikangas) (PDF/507.08 KB)
First published: 21/10/2014
Last updated: 21/10/2014 -
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Presentation - Stem cell therapy for myocardial repair (Birgit Assmus) (PDF/6.31 MB)
First published: 21/10/2014
Last updated: 21/10/2014 -
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Presentation - Cell-based therapies for cardiac repair (Claire Beuneu) (PDF/964.96 KB)
First published: 21/10/2014
Last updated: 21/10/2014 -
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Presentation - Clinical aspects for cell-based therapies for cardiac repair (Pieter A. Doevendans) (PDF/3.35 MB)
First published: 21/10/2014
Last updated: 21/10/2014