B3021 - Pharmaceutical Legislation and Deontology

Course contents

Notes on supranational law. The Italian National Health Service: current structure on the three different levels (central, regional and local). Role and Responsibility of Pharmacist. Code of Ethics for Pharmacists.

Structure of the pharmaceutical service. Pharmacies.

Regulation of medicinal products for human use. European Medicines Agency (EMA), Italian Medicines Agency (AIFA), Food and Drug Administration (FDA). Advertising of medicinal products for human use. Wholesale distribution of medicinal products for human use.

Veterinary Medicinal Products Regulation.

National and European rules concerning distribution of health products, such as cosmetics, food supplements or food for specific groups.

Readings/Bibliography

M. Cini, P. Rampinelli. Principi di Legislazione Farmaceutica, Edizioni Minerva Medica, 2019.

P. Minghetti. Legislazione farmaceutica X Ed., CEA, 2021

G.Barberini, L. Casettari. Legislazione farmaceutica nella pratica professionale. Piccin, 2021

 

Slides presented in class are not a substitute for the reference texts

Teaching methods

Theorical lessons.

The attendance requirement is considered fulfilled by attending at 60% of lectures. Attendance is recorded using the student attendance application.

Assessment methods

Oral examination.

 

Students with Specific Learning Disorders (SLD) or temporary/permanent disabilities: It is strongly recommended to contact the relevant University Office in advance (https://site.unibo.it/studenti-con-disabilita-e-dsa/en). The office will be responsible for proposing any necessary accommodations to the interested students, which must be submitted for the instructor's approval at least 15 days in advance. The instructor will evaluate their suitability in relation to the course's learning objectives.

Teaching tools

The theoretical lessons will be held by using slides.

Office hours

See the website of Teresa Cerchiara