The workshop comes near the conclusion of the SIMPLERAD project, providing an opportunity to present the consortium’s achievements since its beginning in May 2022. The WP teams have conducted a literature review and gathered information on the regulatory frameworks in several EU and non-member countries to understand and compare the legal requirements for authorisation of radiopharmaceuticals and practice of therapeutic nuclear medicine. Additionally, a survey and expert interviews collected information on the practical implementation of the legal requirements and challenges to practitioners. These have been combined to develop guidance for the coherent implementation of the legal requirements to be published in the project’s final report.
The workshop will gather the consortium’s crucial stakeholders such as its Advisory Board, Article 31 Working Party on Medical Exposures (WP MED), and SAMIRA Steering Group on Quality and Safety (SGQS) as well as regulatory authorities and medical professional and patient advocacy groups. Their feedback is essential to the finalisation and implementation of the consortium’s guidance. Detailed briefings to moderators as well as assignment of rapporteurs for each session, who will summarise the main items identified in each session as well as conclusions and recommendations directly at the end of each session, will ensure that the workshop will lead to concrete conclusions and detailed recommendations. In addition, a panel discussion session is foreseen structured according to the project tasks, which will also contribute to concrete recommendations and conclusions. A special emphasis will be put on the identification and realisation of actions that are needed to advance the coherent implementation of the European legal requirements with respect to therapeutic nuclear medicine. Action points will be defined that provide a roadmap for structure, milestones and timelines to give guidance to the European Commission (EC), the professional communities and other key stakeholders.