PHARMACEUTICAL REGULATIONS AND REGULATORY BODIES

Università degli Studi
"G. d'Annunzio"

Chieti - Pescara

Single discipline educational activity

Course Sheet

Course code:

TE0017

Academic Year of enrolment:

2022

Year of supply:

2024/2025

Type of Course:

Characterising

Degree:

Course of 1st Cycle Degree in SUSTAINABLE TECHNOLOGIES AND ENVIRONMENTAL TOXICOLOGY

Disciplinary Sector:

Applied Technological Pharmaceutics

Language:

Italian

Location:

CHIETI

Credits:

Programme Year:

Professor and Collaborators:

MARINELLI LISA

Cycle:

First semester

Obligatory attendance:

Yes

Minimum hours of attendance:

Hours of classroom activity:

Individual study hours:

136

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.

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.

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

Extended Syllabus

Organization of the Italian State: basic notions.
The drug market.
Pharmaceutical service: historical aspects and its evolution.
Decentralization of state functions in the field of healthcare.
Technical, scientific, and advisory bodies of the Ministry of Health (L. 317/01). Bodies at the national level, the Higher Institute of Health (ISS), the Higher Council of Health (CSS).
Functions of AIFA, EMA (EMEA) and ICH.
Italian Medicines Agency (AIFA): areas of competence and commissions.
Medical devices: In vitro diagnostics: Legislative Decree 332/2000. Single Commission on Medical Devices (CUD). Device Advertising. Food supplements: European directive 46/02.
The Pharmacopoeias: Italian Official Pharmacopoeia,
European Pharmacopoeia.
New community code of medicines for human use (Legislative Decree 219/2006) and veterinary (Reg UE 6/2019).
The Pharmaceutical Service.
Pharmacovigilance. Pharmacovigilance: definition, role and tools.
Law and regulation of the environmental impact of drugs (Environmental Risk Assessment, ERA).

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. e successive integrazioni/correzioni.
- Materiale didattico fornito dal docente.

Methods of Provision

Conventional

Teaching Methods

The course consists of 64 hours of frontal lessons.

Evaluation methods

Verification of learning:

The evaluation will be carried out through a written test and an oral test.
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.

Contacts/More Information

Available material provided by the Professor.

Università degli Studi
"G. d'Annunzio"

Chieti - Pescara

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