title: Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Products Successfully to the Market - Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014.
abstract: On September 11, 2014, a workshop entitled 'Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Product Successfully to the Market' was held at the 47th annual meeting of the German Society for Transfusion Medicine and Immunohematology (DGTI), co-organised by the European Medicines Agency (EMA) and the DGTI in collaboration with the German Stem Cell Network (GSCN). The workshop brought together over 160 participants from academia, hospitals, small- or medium-sized enterprise developers and regulators. At the workshop, speakers from EMA, the Committee for Advanced Therapies (CAT), industry and academia addressed the regulatory aspects of development and authorisation of advanced therapy medicinal products (ATMPs), classification of ATMPs and considerations on cell-based therapies for cardiac repair. The open forum discussion session allowed for a direct interaction between ATMP developers and the speakers from EMA and CAT.
authors.affiliation: Committee for Advanced Therapies, European Medicines Agency, London, UK ; European Medicines Agency, London, UK.
authors.forename: Patrick
authors.initials: P
authors.lastname: Celis
authors.affiliation: Committee for Advanced Therapies, European Medicines Agency, London, UK ; Agence nationale de sécurité du médicament et des produits de santé (ANSM), Paris, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Ferry
authors.affiliation: Committee for Advanced Therapies, European Medicines Agency, London, UK ; Norwegian Medicines Agency, Oslo, Norway.
authors.forename: Marit
authors.initials: M
authors.lastname: Hystad
authors.affiliation: Committee for Advanced Therapies, European Medicines Agency, London, UK ; Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
authors.forename: Martina
authors.initials: M
authors.lastname: Schüßler-Lenz
authors.affiliation: Committee for Advanced Therapies, European Medicines Agency, London, UK ; European Society of Cardiology, University Medical Center Utrecht, Department of Cardiology, Utrecht, the Netherlands.
authors.forename: Pieter A
authors.initials: PA
authors.lastname: Doevendans
authors.affiliation: Committee for Advanced Therapies, European Medicines Agency, London, UK ; Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
authors.forename: Egbert
authors.initials: E
authors.lastname: Flory
authors.affiliation: Committee for Advanced Therapies, European Medicines Agency, London, UK ; Agence Fédérale des Médicaments et des Produits de Santé, Brussels, Belgium.
authors.forename: Claire
authors.initials: C
authors.lastname: Beuneu
authors.affiliation: Committee for Advanced Therapies, European Medicines Agency, London, UK ; BASG/AGES, Vienna, Austria.
authors.forename: Ilona
authors.initials: I
authors.lastname: Reischl
authors.affiliation: Committee for Advanced Therapies, European Medicines Agency, London, UK ; Finnish Medicines Agency, Helsinki, Finland.
authors.forename: Paula
authors.initials: P
authors.lastname: Salmikangas
keywords: ATMP; Advanced therapy medicinal products; CAT; Committee for Advanced Therapies