- EU Projects
WP1 will conduct an analysis of the interrelations between the European pharmaceutical legislation and Council Directive 2013/59/Euratom’s requirements for therapeutic nuclear medicine.
More specifically, WP1 will complete the following tasks.
The objective of WP2 is to develop, undertake and analyse a survey on the practical implementation of the main aspects of European pharmaceutical legislation and the BSSD concerning therapeutic nuclear medicine.
A multi-tiered approach will be taken to evaluate the heterogeneity in the relevant provision for individualised patient-dose planning, including patient-specific dosimetry, radiopharmaceutical preparation, provision and involvement of the MPE, presence and implementation of national legislation and guidance pertaining to selected dose constraints, patient release criteria, and radioactive waste management.
To identify the existing gaps in implementing the above requirements and main barriers encountered in the development and use of therapeutic radiopharmaceuticals, the survey will target a number of European stakeholders across a breadth of aspects pertaining to nuclear medicine therapy. Identified stakeholders include industrial radiopharmaceutical companies, competent authorities and national regulators, national nuclear medicine and medical physics societies, national training schools, and individual experts working in the clinical field.
WP3 will identify and implement further actions to advance the coherent implementation of the European legal requirements with respect to therapeutic nuclear medicine, based on the issues identified by WP1 and WP2.
A list of potential issues to be addressed include the following.
WP4 will organise a workshop to present and validate the results of the work carried out under WPs 1–3 and discuss issues relating to regulations, development and use of therapeutic nuclear medicine with the relevant stakeholders.
More specifically, WP4 will perform the following.
The workshop will bring together the following groups.
In addition, the Advisory Board members as well as the SAMIRA SGQS and Article 31 WP MED, in alignment with the EC, will be invited to join the workshop.