D2.1 Documentation of regulatory needs for cardiotoxicity methods and data

This document aims to provide an overview on the regulatory needs for cardiotoxicity methods and data that can be used for consultation of national and European Preliminary Assessment of REgulatory Relevance (PARERE) Networks. We provide a brief overview of 1) the scientific knowledge about cardiotoxicity induced by chemical stressors, 2) the current regulatory assessment frameworks for cardiotoxicity and their needs for improvement, and 3) specific New Approach Methodologies (NAMs)-based assessment tools, which are available or in development, with a specific focus on the work performed in the European project ALTERNATIVE (https://alternative-project.eu/). In addition, a set of questions for PARERE regulators is included and we aim to receive feedback on the regulatory relevance of these three aspects.