Les enjeux de la RIV et de la recherche clinique en termes de radioprotection : point de vue de l’ASN

In her presentation, Carole Rousse from the ASN addresses three key topics: the European Commission's SIMPLERAD project, nuclear medicine authorizations and ASN's ongoing work. SIMPLERAD aims to improve understanding of the links and interaction between European pharmaceutical legislation and the radiation protection requirements of the EURATOM BSS (Basic Safety Standards) directive, and to highlight the obstacles to the consistent implementation of radiopharmaceutical therapies in clinical practice. The study formulates practical recommendations for the safe use of new radiopharmaceutical products, including dosimetry requirements, patient release, conditions after therapeutic procedures and waste management. The project highlights a lack of articulation between pharmaceutical legislation and the BSS directive, as well as a lack of clarity in the BSS on expectations in terms of optimization, which makes it difficult to apply the BSS directive. She underlines the challenges linked to radiation protection with the arrival of new radiopharmaceuticals in nuclear medicine clinical trials, in particular the lack of data to assess radiation protection issues for patients, carers and conforters, professionals, the public and the environment, which should be collected as early as possible at the design phase. Lastly, she cites work in progress on revising the ASN resolution on the disposal of radionuclide-contaminated waste and effluents (ASN, 2008), the management of radioactive waste produced in patients’ homes, new radiopharmaceutical drugs and clinical trials, and concludes by stressing the importance of European cooperation to improve regulations and secure access to new therapies.