LF0010 - PHARMACEUTICAL TECHNOLOGY AND LEGISLATION (A-G)

courses

ID:

LF0010

Duration (hours):

60

CFU:

SSD:

FARMACEUTICO TECNOLOGICO APPLICATIVO

Located in:

CHIETI

Url:

Course Details:

PHARMACY/CORSO GENERICO Year: 5

Year:

2025

Course Catalogue:

https://unich.coursecatalogue.cineca.it/af/2025?co...

Date/time interval

Primo Semestre (01/10/2025 - 31/01/2026)

Course Objectives

The expected learning outcomes are related to the necessary competences in the pharmaceutical technology sector for the purposes of a complete knowledge of the legislative regulations with particular regard to the regulatory provisions of pharmacist.

Course Prerequisites

The preparatory course is Pharmaceutical Technology with Labs, furthermore the student must have acquired general notions of pharmacology, relating to the usual and maximum dosages of medicines, drug administration routes, chemical-physical incompatibilities of drug mixtures and skills on drug-excipient interactions and medicine-primary Packaging.

Teaching Methods

48 hrs of lessons and 12 of simulated pharmacy activity

Assessment Methods

The evaluation will be carried out through a written test of legilation and an oral test.
The written test concerns the regulatory commentary on prescriptions relating to medicines prepared by industry and / or prepared in pharmacies as well as open-ended questions relating to the regulatory and pharmaco-economic issues of the topics in the course. The oral exam includes a critical discussion of the topics developed during the semester of activity.

Texts

Minghetti P. Legislazione Farmaceutica. CEA Milano
-J. L. Bootman, R. J. Townsend. W. F. McGhan. Introduzione alla Farmacoeconomia. OEMF.
- F.U.I. XII ed

-Italian Pharmacopoeia.
-European Pharmacopoeia.
- The Pharmaceutical Service
-Hospital pharmacies.
-The prescription: definition and classification, the obligations of pharmacist
- Medicinal products for veterinary use
-Narcotic drugs and psychotropic substances
-Good Manufacture Practices.
- Generics: current regulations on production and marketing.
-Biosimilars
-Off label use for pharmaceutical drugs
-Procedures for authorizing the production of the active ingredients and medicinal products for human and veterinary use.
- Cosmetics legislation
- Classification of medical devices
-Botanicals: pharmaceutical and legislation overview
- Labeling, packaging and advertising of medicines.

Course Language

Italian

More information

It is possible to participate, upon registration, in Seminars / Exercises held by Professionals at the "Didactic Pharmacy" of the Department of Pharmacy