TY - STD TI - Clinical Trial regulation. 2018. https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trial-regulation. Accessed 22 Nov 2018. UR - https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trial-regulation ID - ref1 ER - TY - STD TI - Decristoforo C and Patt M. EJNMMI Radiopharm Chem 2017;1(1): 12. Are we “preparing” radiopharmaceuticals? DOI:https://doi.org/10.1186/s41181-016-0011-7 ID - ref2 ER - TY - STD TI - EMA/CHMP/SWP/686140/2018. 2018. https://www.ema.europa.eu/documents/scientific-guideline/draft-guideline-non-clinical-requirements-radiopharmaceuticals-first-version_en.pdf. Accessed 01 Dec 2018. UR - https://www.ema.europa.eu/documents/scientific-guideline/draft-guideline-non-clinical-requirements-radiopharmaceuticals-first-version_en.pdf ID - ref3 ER - TY - STD TI - Q&A: New rules for clinical trials conducted in the EU. 2014 http://europa.eu/rapid/press-release_MEMO-14-254_en.htm. Accessed 21 Nov 2018. UR - http://europa.eu/rapid/press-release_MEMO-14-254_en.htm ID - ref4 ER - TY - JOUR AU - Tenti, E. AU - Simonetti, G. AU - Bochicchio, M. T. AU - Martinelli, G. PY - 2018 DA - 2018// TI - Main changes in European clinical trials regulation (no 536/2014) JO - Contemp Clin Trials Commun VL - 11 UR - https://doi.org/10.1016/j.conctc.2018.05.014 DO - 10.1016/j.conctc.2018.05.014 ID - Tenti2018 ER -