Informazioni di Regulatory Activities

Dipartimento: Scienze Matematiche, Fisiche E Naturali
Settore Ministeriale: IUS/09
Codice di verbalizzazione: 8067317
Metodi di insegnamento: Frontale
Metodi di valutazione: Orale
Prerequisiti: General concepts on clinical research and basic knowledge on clinical trials
Obiettivi: The aim of the course is to provide students with a general knowledge on "regulatory" matters, which is indispensable for orienting oneself in the complex 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, with particular attention to the ethical-scientific issues at the origin of the aforementioned rules and documents. At the end of the course the student will have acquired the indispensable tools to orientate himself in the context of the differnt authorization processes and will be able to recognize and evaluate the various problems that the subject involves.

Navigazione Utente: