While nuclear medicine and the use of radiopharmaceuticals are paving the way towards a new paradigm especially in cancer care and personalised medicine for many diseases and medical conditions, challenges to ensure and maintain high standards in quality and safety of nuclear medicine treatments are increasing. Many of these challenges relate to the complex and fragmented regulatory framework regulating the preparation and use of radiopharmaceuticals in general and therapeutic radiopharmaceuticals specifically. In therapeutic nuclear medicine, use of radionuclides has a long history. However, most of the innovative therapeutics are radiopharmaceuticals. This has led to significant changes in the manufacturing process. Today, radiopharmacies play a crucial role in the manufacture of therapeutic nuclear radiopharmaceuticals for both industry and hospital radiopharmacies.
According to the SAMIRA Action Plan, the consortium aims to ensure EU citizens have access to high-quality and safe nuclear technologies in medicine. The general objectives pillars to be addressed to meet this challenge are the following.
- Improve the understanding of the links and interdependencies between the European pharmaceutical legislations and Euratom radiation protection requirements
- Highlight potential barriers to implementation
- Propose practical guidance and recommendations to advance a coherent implementation of these requirements with respect to the therapeutic use of radiopharmaceuticals
- Address quality and safety issues related to the current use and introduction of novel therapeutic radiopharmaceuticals into clinical practice, including requirements for dosimetry, the role of MPEs, release of patients from hospital, and management of radioactive waste
To fulfill the objectives outlined in the tender, this project will be performed by a consortium consisting of three leading European medical societies: the European Institute for Biomedical Imaging Research (EIBIR), European Association for Nuclear Medicine (EANM) and European Federation of Organisations for Medical Physics (EFOMP). The consortium features a multi-disciplinary team of professionals from the following areas of expertise: nuclear medicine (diagnosis and treatment), medical physics, radiopharmacy, regulatory expertise in pharmaceuticals and medical radiation protection, waste management, patient release, project management, and coordination.
In the project’s 4 work packages, the project’s path to completion of its objectives, the deliverables and the milestones have been mapped for the next 2 years. All research publications will be made freely accessible on the SIMPLERAD website.
This project has received funding from the European Commission under Service Contract N°ENER/2022/NUCL/SI2.869532, and is organised by the project offices of EIBIR and EANM Research, Ltd. Much more can be found on the project’s website.
Facts and figures
Coordinator: European Institute for Biomedical Imaging Research (EIBIR)
Number of Partners: 3
Start Date: May 1, 2022
End Date: April 30, 2024
Total Funding: € 300,000.00
This project has received funding from the European Commission under Service Contract N°ENER/2022/NUCL/SI2.869532.