Chimeric antigen receptor (CAR) T-cell therapy registries workshop
Date:
09/02/2018
Location:
European Medicines Agency, London, UK
The objective of this workshop is to facilitate the long-term follow up of CAR-T cell products in a real world setting and enable the generation of meaningful efficacy and safety data using haemato-oncological registries. It will aim to agree on implementable recommendations on core data elements to collect and other matters including patient consent, governance, quality assurance and registry interoperability as well as recommendations to optimise collaboration among registry holders, marketing authorisation holders and applicants and regulators.
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Report - CAR-T cell therapy registries workshop (PDF/492.27 KB)
First published: 22/05/2018
Last updated: 22/05/2018
EMA/204454/2018 -
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Appendix 1: Proposed data elements relating to efficacy and to safety - CAR-T cell therapy registries workshop (PDF/161.46 KB)
First published: 22/05/2018
Last updated: 22/05/2018
EMA/299528/2018 -
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Appendix 2: Agenda and Participants - CAR-T cell therapy registries workshop (PDF/97.26 KB)
Draft
First published: 25/01/2018
Last updated: 22/05/2018
EMA/794031/2017