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SUMMARY:Fundamentals of Research in Imaging and Theranostics – Part 1: Research Design
DESCRIPTION:UEMS EACCME has granted the accreditation of 4 CME credits for this event. \n\n\n\nThis online course is part of a long line of research methodology which is aimed at providing interested participants with information about the preclinical development and clinical translation\, as well as the design\, conductance and reporting of clinical research trials\, with a specific emphasis on radiopharmaceuticals for both diagnostic and therapeutic applications.  \n\n\n\nThese first two modules will represent part one of the course.  \n\n\n\nModule 1 will focus on the entire path from preclinical development to clinical translation of an imaging compound\, including the preclinical studies needed for the selection of a new candidate for clinical translation\, an overview of EU legislation on radiopharmaceuticals for diagnosis and therapy\, and the assessment of quality data and non-clinical data (pharmacology\, dosimetry and toxicology) for the IMP dossier.  \n\n\n\nModule 2 will be focused on the design of a proper trial. It will cover: the definition of objectives\, aims\, endpoints\, population\, statistical methods and examples of trial design schemes\, as well as dosimetry as far as healthy organs and in case of therapy tumour-absorbed dose. It will have a special focus on phase 0\, phase 1-2 trial\, early clinical phase 0-1-2 and investigator-driven clinical trial. \n\n\n\n \n\n\n\n\n\n\n\nSave yourself a seatEnter the eLearning store to register for the course. Having trouble? See the short tutorial here. Register now!\n\n\n\n\n\n\n\n\n\nLearning Objectives:\n\n\n\nLearn about: \n\n\n\n\nPreclinical development and clinical translation of radiopharmaceuticals \n\n\n\nThe legislation on radiopharmaceuticals with a specific focus on the European scenario \n\n\n\nRequirements of IMPD for radiopharmaceuticals for imaging agents and theranostic/therapeutic molecules Interpretation of preclinical data to properly design and plan the clinical trial \n\n\n\nPhase 0\, phase 1 and phase 2 clinical trials with radiopharmaceuticals design \n\n\n\nPhase 0\, phase 1 and phase 2 clinical trials with radiopharmaceuticals conductance \n\n\n\nGMP\, GLP and GCP principles \n\n\n\nImportance of radioprotection and dosimetric estimates in early phase clinical trials\n\n\n\n\n\n\n\n\n\n\n\n\nTarget Audience:\n\n\n\n\nResearchers\, scientists\, nurses\, pharmacologists\, radiopharmacists\, residents and specialists in Nuclear Medicine/Oncology/Radiology who want to understand how clinical trials with radiopharmaceuticals in the early phase are unique and how the corresponding documents and trial design should be appropriately planned.\n\n\n\n\n\n\n\n\n\n\nProgrammeClick to see the full event programme.  View the Programme\n\n\n\n\n\n\n\nFaculty\n\n\n\n\n\nPaola Anna ErbaUniversità degli Studi di Milano-Bicocca\, Italy \n\n\n\n\n\nSona BalogovaComenius University\, Bratislava\, Slovakia \n\n\n\n\n\nElisabeth von GuggenbergMedical University Innsbruck\, Austria \n\n\n\n\n\n\n\nMartina SolliniVita-Salute San Raffaele University\, Milan\, Italy \n\n\n\n\n\nLuigi AlojUniversity of Cambridge\, United Kingdom \n\n\n\n\n\nMeltem OcakIstanbul University\, Turkey \n\n\n\n\n\n\n\nPeter LavermanRadboud Universiteit Nijmegen\, The Netherlands \n\n\n\n\n\nJane SosabowskiQueen Mary\, University of London\, United Kingdom \n\n\n\n\n\nPetra KolencUniversity Medical Centre Ljubljana\, Slovenia \n\n\n\n\n\n\n\nClemens DecristoforoMedical University Innsbruck\, Austria \n\n\n\n\n\nPiotr GarnuszekPOLATOM\, Warsaw\, Poland \n\n\n\n\n\nRenata MikolajczakPOLATOM\, Warsaw\, Poland \n\n\n\n\n\n\n\nTheodosia MainaNCSR Demokritos\, Athens\, Greece \n\n\n\n\n\nMark KonijnenbergErasmus MC\, Rotterdam\, The Netherlands \n\n\n\n\n\n\n\n\n\nRegistration Details\n\n\n\nRegistration Fee\n\nCourse Fee              Free \n\n\n\n\n\n\n\n\n\nEvent Overview
URL:https://esmit.eanm.org/event/fundamentals-of-research-in-imaging-and-theranostics-part-1-research-design/
LOCATION:Online
CATEGORIES:Research Methods,Self-paced Online Course
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