ENER/D3/2021-253-3 – SAMIRA Study on the Implementation of the Euratom and the EU Legal Bases with Respect to the Therapeutic Uses of Radiopharmaceuticals

Description

The specific objective of this work is to improve the understanding of the links and the inter-dependencies between the European pharmaceutical legislations and the Euratom radiation protection requirements. Lot 1: The specific objective of this work is to improve the understanding of the links and the inter-dependencies between the European pharmaceutical legislations and the Euratom radiation protection requirements. It will propose practical guidance and recommendations on advancing a coherent implementation of these requirements with respect to therapeutic use of radiopharmaceuticals. The study will further cover quality and safety issues relating to the introduction of novel therapeutic radiopharmaceuticals into clinical practice, including requirements for medical physics experts, release of patients and management of hospital waste. Please consult the procurement documents available at the address indicated in Section I.3). Lot 1: The specific objective of this work is to improve the understanding of the links and the inter-dependencies between the European pharmaceutical legislations and the Euratom radiation protection requirements. It will propose practical guidance and recommendations on advancing a coherent implementation of these requirements with respect to therapeutic use of radiopharmaceuticals. The study will further cover quality and safety issues relating to the introduction of novel therapeutic radiopharmaceuticals into clinical practice, including requirements for medical physics experts, release of patients and management of hospital waste. Please consult the procurement documents available at the address indicated in Section I.3).