SAMIRA study on the implementation of the Euratom and the EU legal bases with respect to the therapeutic uses of radiopharmaceuticals
This tender is proposed jointly by the European Institute for Biomedical Imaging Research (EIBIR), EANM Forschungs GmbH (EANM), and European Federation of Organisations for Medical Physics (EFOMP), represented in the project as follows:
WP1: Analysis of the interrelations between EU pharmaceutical legislation and Council Directive 2013/59/Euratom
WP2: Survey and analysis of the implementation of relevant European legal requirements for therapeutic nuclear medicine
WP3: Advancing coherent implementation of European legal requirements for therapeutic nuclear medicine
WP4: Organisation of a European workshop
An Advisory Board has been established to provide views on the methodology and results of the work at each step of the project. This board will include representatives from relevant international organizations and stakeholders from the United Kingdom and United States of America, as well as regulators, industry stakeholders, patients and other stakeholders not otherwise represented in the project.