Regulatory considerations and directions for the European CAR-T landscape


Regulatory considerations and directions for the European CAR-T landscape are critical themes of the meeting, with an EMA perspective on CAR-T marketing authorization, as well as post marketing safety and efficacy studies. A patient representative provided a personal, non-clinical perspective on CAR T-cell regulation and access. Leading European grants/projects were reviewed in a session that covered progress on the CARAMBA, EURE-CART, CARAT and imSAVAR studies. One of the concluding sessions addressed the key issue of CAR T-cell implementation and practical recommendations coming from Real World  evidence in Europe and the USA.

Click on the titles below to read more and view the presentations (if available).

Marketing authorization of CAR T-cells - the EMA perspective (Martina Schüssler-Lenz, Germany)

Creating a country-wide selection algorithm (the Austrian experience) (Ulrich Jäger, Austria)

PASS and PAES: The need for registration, short- and long-term follow-up of patients treated with gene therapy medicinal products (Christian Chabannon, France)

CARAT (H2020, CAR-T manufacturing) (Mario Assenmacher, Germany)

imSAVAR (Ulrike Köhl, Germany)

Real-world evidence in the EU (Gilles Salles, France)

Real-world evidence (RWE) in the USA (Marcelo Pasquini, USA)