TE0017 - PHARMACEUTICAL REGULATIONS AND REGULATORY BODIES

courses
ID:
TE0017
Duration (hours):
64
CFU:
8
SSD:
FARMACEUTICO TECNOLOGICO APPLICATIVO
Located in:
CHIETI
Url:
SUSTAINABLE TECHNOLOGIES AND ENVIRONMENTAL TOXICOLOGY/CORSO GENERICO Year: 3
Year:
2025
Course Catalogue:
https://unich.coursecatalogue.cineca.it/af/2025?co...

Overview

Date/time interval

Primo Semestre (01/10/2024 - 31/01/2025)

Syllabus

Course Objectives

The expected learning outcomes are in relation to the basic knowledge on the Italian State Law, on the regulatory bodies of national and extra-national drugs, on pharmacovigilance and on the regulation of the environmental impact of drugs (Environmental Risk Assessment, ERA) in accordance with the most modern guidelines - EMA (European Medicines Agency) guide.

Course Prerequisites

The cultural bases of the students who attend the course are mainly identified in a good knowledge of Analytical Chemistry and Organic Chemistry and Industrial Drug Development.

Teaching Methods

The course consists of 64 hours of frontal lessons.

Assessment Methods

Two in-course assessments are scheduled. Students who do not take part in the in-course assessments will be assessed through a written exam and an oral exam. The written test concerns open-ended or multiple choice questions regarding regulatory and pharmaco-economic issues. The oral exam includes a critical discussion of the arguments 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. e successive integrazioni/correzioni.
- Materiale didattico fornito dal docente.

Contents

-Organization of the Italian State
-Pharmaceutical service
-Technical, scientific, and advisory bodies of the Ministry of Health (L. 317/01).
-Italian Medicines Agency (AIFA)
-Medical devices
-Pharmacopoeias
-New community code of medicines for human use (Legislative Decree 219/2006) and veterinary (Reg UE 6/2019).
-The Pharmaceutical Service.
-Pharmacovigilance
-Law and regulation of the environmental impact of drugs

Course Language

Italian

More information

Available material provided by the Professor.

Degrees

Degrees

SUSTAINABLE TECHNOLOGIES AND ENVIRONMENTAL TOXICOLOGY 
Bachelor’s Degree
3 years
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