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Fundamentals of Research in Imaging and Theranostics – Part 1: Research Design

UEMS EACCME has granted the accreditation of 4 CME credits for this event.

This 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.

These first two modules will represent part one of the course.

Module 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.

Module 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.

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Learning Objectives:

Learn about:

Preclinical development and clinical translation of radiopharmaceuticals
The legislation on radiopharmaceuticals with a specific focus on the European scenario
Requirements of IMPD for radiopharmaceuticals for imaging agents and theranostic/therapeutic molecules Interpretation of preclinical data to properly design and plan the clinical trial
Phase 0, phase 1 and phase 2 clinical trials with radiopharmaceuticals design
Phase 0, phase 1 and phase 2 clinical trials with radiopharmaceuticals conductance
GMP, GLP and GCP principles
Importance of radioprotection and dosimetric estimates in early phase clinical trials

Target Audience:

Researchers, 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.

Programme

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Faculty

Paola Anna Erba

Università degli Studi di Milano-Bicocca, Italy

Sona Balogova

Comenius University, Bratislava, Slovakia

Elisabeth von Guggenberg

Medical University Innsbruck, Austria

Martina Sollini

Vita-Salute San Raffaele University, Milan, Italy

Luigi Aloj

University of Cambridge, United Kingdom

Meltem Ocak

Istanbul University, Turkey

Peter Laverman

Radboud Universiteit Nijmegen, The Netherlands

Jane Sosabowski

Queen Mary, University of London, United Kingdom

Petra Kolenc

University Medical Centre Ljubljana, Slovenia

Clemens Decristoforo

Medical University Innsbruck, Austria

Piotr Garnuszek

POLATOM, Warsaw, Poland

Renata Mikolajczak

POLATOM, Warsaw, Poland

Theodosia Maina

NCSR Demokritos, Athens, Greece

Mark Konijnenberg

Erasmus MC, Rotterdam, The Netherlands

Registration Details

Course Fee               € 300.- + Local VAT Rate

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Event Overview

€300 + Local VAT Rate

ESMIT

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