94172 - Pharmacology and Regulatory Aspects of Clinical Trials

Learning outcomes

At the end of the course, the student must possess the knowledge and skills to understand the regulatory bases for clinical trials and the marketing of medicinal products as well as the minimum knowledge on pharmacovigilance and pharmacoepidemiology.

Course contents

1) The clinical development of drugs and marketing authorization (MA) procedures.

2) Therapeutic innovation of drugs: classification and examples.

3) The surveillance of adverse drug reactions in daily practice.

4) Drug-drug interactions.

5) To prevent errors in therapy: classification and examples.

6) Scientific and regulatory issues for generic drugs and biosimilars.

7) The national and regional pharmaceutical handbook with notes on the classification of drugs according to their prescribing and reimbursement.

8) Factors affecting inter-individual variations in drug responses: the pharmacogenetics.

9) Sex and gender differences in pharmacology.

Readings/Bibliography

Slides and lecture notes.

Teaching methods

Lectures in the classroom and online.

Assessment methods

Questionnaire consisting of 31 questions with 4 possible answers of which only one is correct. The questions concern the whole program of the course. The time available for the written test is 30 minutes. During the test it is not allowed to use support material such as: textbooks, notes, computer supports. The maximum score obtainable by providing all correct answers is 30 cum laude. The minimum score is 18/30.

Teaching tools

PC and Video-projector

Office hours

See the website of Domenico Motola