REGULATORY ASPECTS OF BIOTECHNOLOGICAL DRUGS
Academic Year 2025/2026 - Teacher: MARIANGELA CHISARIExpected Learning Outcomes
Acquisition of basic knowledge about drugs and the development of new drugs
Course Structure
Traditional classes. Students are invited to actively participate with questions and comments on discussed topics.
Required Prerequisites
None
Attendance of Lessons
Mandatory attendance to classes, except for new instructions for contingent reasons
Detailed Course Content
Drugs and medications
Preclinical and clinical drug testing
Interventional and observational studies
Pharmacovigilance
Textbook Information
- Elementi di Scienze Regolatorie del Farmaco, Cammarata e Pani, Edra
Course Planning
| Subjects | Text References | |
|---|---|---|
| 1 | Drugs and medications | see texbook tab |
| 2 | Preclinical and clinical drug testing | see texbook tab |
| 3 | Interventional studies and observational studies | see texbook tab |
| 4 | Pharmacovigilance | see texbook tab |
Learning Assessment
Learning Assessment Procedures
Oral exam about topics listed in the program and discussed during classes. The final evaluation will be determined by appropriate use of the scientific language, the ability to explain what has been learned, as well as by the skills of critical thinking.
Examples of frequently asked questions and / or exercises
Clinical trials, origin of drugs
VERSIONE IN ITALIANO