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WP4 - Regulator engagement strategy - 1st questionnaire for the EuroGCT Consortium

Identification of existing interactions and needs of interactions between gene and cell therapies stakeholders and regulators

Aim of this 1st questionnaire

This questionnaire aims to identify existing forms (e.g. procedures, meetings, discussion’s forum) of exchanges between gene and cell therapies stakeholders and regulators, as well as needs of new or enhanced interactions between them in order to build a EuroGCT strategy for stakeholder’s liaison with regulatory agencies in accordance with WP4’s objectives.

“Regulators” in this questionnaire has a wide meaning. It covers the regulatory agencies that are involved in gene and cell therapies, especially regarding the advanced therapy medicinal products’ development pathway. Thus, it mainly covers the European Medicines Agency, National medicines agencies, Health Technology Assessment bodies. But it can also cover research funding and authorization authorities, patent offices, ethics bodies/committees, notified bodies (in the context of combination with medical devices), data authorities, authorities providing guidelines, or good practices in the field of gene and cell therapies.

Please, where relevant, specify as much as possible if you are considering a specific (type of) regulator.