Chimeric antigen receptor (CAR) T-cell therapy registries workshop

• Date:
  Friday, 09 February 2018
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

Report - CAR-T cell therapy registries workshop

Reference Number: EMA/204454/2018

Appendix 1: Proposed data elements relating to efficacy and to safety - CAR-T cell therapy registries workshop

Reference Number: EMA/299528/2018

Appendix 2: Agenda and Participants - CAR-T cell therapy registries workshop

DraftReference Number: EMA/794031/2017