Advanced Therapy Medicinal Products (ATMPs) represent a groundbreaking frontier in modern medicine, offering transformative treatments for previously untreatable diseases through innovative cell-based, gene-based, and tissue-engineered therapies. To help developers navigate the complexities of bringing these cutting-edge therapies to patients, this upcoming webinar, organized jointly by the EIC and EMA will provide a overview of the EU regulatory framework for cell and gene therapies, ensuring developers understand key compliance and approval pathways, as well as available support for developers.

The webinar is aimed at developers, including SMEs and academia, and will include a presentation of the regulatory path to authorization of these products and scientific considerations for early-stage development, highlighting key factors for the quality/manufacturing, non-clinical and clinical development plans. The webinar will also present the different support mechanisms in place and discuss the respective role of National Competent Authorities and EMA in this process, clarify how developers can leverage the joint scientific advice process between National Competent Authorities (NCAs) and the European Medicines Agency (EMA) to streamline their regulatory journey, optimize their interactions and accelerate development timelines. The webinar will conclude with recent updates from the EU General Pharma Legislation. In addition, the webinar will allow for extensive Q&A with the audience.

Participants are kindly invited to register using this form by 18 May 2026 at 12:00 (noon). Questions you would like to be addressed during the webinar can be submitted through the registration form.