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ISCT EU Webinar: Cell Therapy Clinical Trials in the EU (Nov. 25, 2014)

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"Cell Therapy Clinical Trials in the EU''

Event Date: Tuesday, November 25th, 2014
6am-7am Pacific; 9am-10am Eastern; 3pm-4pm CET (Europe)

Organized by the ISCT Europe Regional Executive Committee


  • Edwin Wagena, PhD, ISCT Europe Regional Vice-President 2014-2016, Amsterdam, The Netherlands


  • Martin Hildebrandt, MD, PhD, Head, GMP Facility, Technische Universität München, Munich, Germany 
  • Mark W Lowdell, PhD, FRCPath, FSB, Director of Cellular Therapy & Biobanking, Royal Free London, London, UK
  • Andrea HauserPhD, Operational Head, José Carreras Center for Somatic Cell Therapy (JCC), University Hospital Regensburg, Regensburg, Germany
  • Pauline MeijPhD, Senior Scientist, Interdivisional GMP Facility (IGFL),  Leiden University Medical Center (LUMC), Leiden, The Netherlands


  • ATMPs, Preclinical Development, and Early Phase Clinical Trials

Target Audience:

  • Clinical practitioners/MDs, GMP community involved in the manufacture of IMPs, regulators


1. Introduction into GCP, overlaps between GMP and GCP

This part of the webinar will focus on points of importance and timelines for the development of the IMP as well as of the clinical trial. Especially for Europe, this will address the need for GLP data and the minimum battery of tests to be performed. For the clinical trial, data shall be presented to assist in planning for a manageable trial to avoid problems in patient recruitment and failure to perform the trial successfully. Will be presented by Mark Lowdell and Martin Hildebrandt

2. EU Regulation of Clinical Trials

Several documents are available for guidance in Clinical Trials with ATMPs that will be presented. Furthermore, documents related to conventional pharmaceutical development offer clues for an easier access to early phase clinical trials in cell-based therapeutics. Will be presented by Mark Lowdell and Martin Hildebrandt

3. Cells and ATMPs as IMPs: GCP-specific considerations (coding, product leaflets, IB)

In this part, the requirements for the coding of IMPs, the details for product leaflets and the IB, legal responsibilities of the IMP manufacturer, the QP and the sponsor of the trial will be touched upon. A structure for the delineation of responsibilities and contract agreements will be presented. Will be presented by Andrea Hauser

4. How to co-develop a product and a trial: TPP and IMPD

Presentation and explanation of draft documents. There are document templates available for download, for instance the IMPD template that our Dutch colleagues in Leiden (P. Meij) have made accessible. Will be presented by Pauline Meij

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