Fundamentals of Research in Imaging and Theranostics – Part 1: Research Design
Self-paced on-demand course
An application has been made to the UEMS EACCME for CME accreditation of 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, which will take place in 2022.
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.
The participants will 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 proper 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, GCP principles
- Importance of radioprotection and dosimetric estimates in early phase clinical trials
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.
No preparatory material.
- Paola Anna Erba
- Sona Balogova
- Elisabeth von Guggenberg
- Martina Sollini
- Luigi Aloj
- Meltem Ocak
- Peter Laverman
- Jane Sosabowski
- Petra Kolenc
- Clemens Decristoforo
- Piotr Garnuszek
- Renata Mikolajczak
- Theodosia Maina
- Mark Konijnenberg
HOW TO REGISTER
- Access your myEANM account (or create a new one)
- Click on the “eLearning Platform” button in the left sidebar menu
- Click on “Register Now!” in the horizontal navigation bar
- You have now entered the course store and are able to register for the webinar in the Online courses section.
Course Fee € 300 + VAT
MODE OF PAYMENT
- Credit card.
- Cheques will not be accepted.