PHARMACEUTICAL TECHNOLOGY AND LEGISLATION

Università degli Studi
"G. d'Annunzio"

Chieti - Pescara

Single discipline educational activity

Course Sheet

Course code:

LF0010

Academic Year of enrolment:

2017

Year of supply:

2021/2022

Type of Course:

Characterising

Degree:

Course of Single Cycle Degree 5 years in PHARMACY

Disciplinary Sector:

Applied Technological Pharmaceutics

Language:

Italian

Location:

CHIETI

Divisions:

Cognomi A-G - Professor: DI STEFANO Antonio
Cognomi H-Z - Professor: MARINELLI LISA

Credits:

Programme Year:

Cycle:

First semester

Obligatory attendance:

Yes

Minimum hours of attendance:

Hours of classroom activity:

Individual study hours:

119

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.

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.

Contents

-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.

Extended Syllabus

-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

Recommended Bibliography

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

Methods of Provision

Conventional

Teaching Methods

56 hrs of lessons

Evaluation methods

Verification of learning:

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.

Contacts/More Information

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

Università degli Studi
"G. d'Annunzio"

Chieti - Pescara

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