Teacher: Salvatore Caruso
Aims:
The course aims to provide students with general knowledge on “regulatory” matters, which is essential for orienting themselves in the complex authorization procedures concerning clinical trials of medicinal products for human use.
The main rules in force and the main national and international reference documents will be illustrated; particular attention will be paid to the ethical, clinical and economic issues that are at the origin of the aforementioned regulations and documents.
At the end of the course the student will be able to demonstrate that he has acquired a good knowledge of the general problems that the complex authorization system, relating to clinical trials of medicines, involves.
Program:
– General information on the regulatory system (hierarchy, differences between the various
regulatory acts)
– Ethical-scientific aspects on the origin and nature of the rules and main documents of
reference, national and international
– Notes on the main types of clinical studies
– Good Clinical Practice-GCP (ethical, scientific, methodological and regulatory aspects);
in-depth analysis of the responsibilities of the different actors present in the GCP
(Investigator, Sponsor, etc.)
– General authorization procedures
– Central Authority and local Ethics Committees (functions and responsibilities)
– Protection of subjects / patients participating in clinical trials (risk/benefit ratio, informed
consent, insurance aspects)
– Authorization procedure for Phase I clinical trials and suitability of experimental sites
– European Union Regulation no. 536/2014 and its implementation
– Therapeutic use of a medicinal product undergoing clinical trials
– Notes on the legislation relating to advanced therapies (stem cells, genetic tests,
biobanks)
– General information on GCP Inspections (differences with Quality Control and Assurance)