LEGISLAZIONE SANITARIA E AMBIENTALE E SISTEMI DI GESTIONE DI QUALITA'

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Module 1

GENERAL KNOWLEDGE OF CIVIL, ADMINISTRATIVE AND PENAL LAWS.

STRUCTURE AND ROLES OF THE EUROPEAN UNION (EU)

EU institutions of health and environmental interest. The sources of the EU regulations: regulations, directives, etc..

STRUCTURE AND ROLES OF THE MAIN NATIONAL HEALTH ORGANIZATIONS

Ministry of Health, ISS, CSS, etc.

THE NATIONAL HEALTH SERVICE (SSN): LEGISLATION, TASKS AND OPERATING STRUCTURES.

PRINCIPLES OF ENVIRONMENTAL LAW AND INSTITUTIONS

Environmental law in Italy and in the EU. EU environmental policy.

The 'One Health' approach.

STRUCTURE AND FUNCTION OF THE MAIN NATIONAL AND INTERNATIONAL ORGANIZATIONS IN THE ENVIRONMENTAL FIELD:

European Medicines Agency (EEA): structure and roles. Reports on the state of the environment and EU operational programs.

Ministry of Environment and related structures: ISS, CNR, ISPRA, ARPA, ARRA Sicilia, ENEA, etc.

Environmental risk assessment in drug production and use (ERA)

REACH (UE Regulation of risk of chemicals)

Module 2

THE EUROPEAN ENVIRONMENT CODE (DL.vo 152/2006 and amendments)

THE PROTECTION OF WATER

Legislation, prevention and authorization regimen and penalties.

Water for human use.

PROTECTION FROM SOIL POLLUTION

The legal framework for the protection of soil.

WASTES AND THEIR DISPOSAL.

The rules governing the production and disposal of waste and their recovery.

Recycling and energy recovery.

Medical and pharmaceutical waste.

THE PROTECTION OF AIR POLLUTION

The main rules at national and community control, prevention and penalties in the field.

THE ENVIRONMENTAL IMPACT ASSESSMENT (VIA), Strategic Environmental Assessment (VAS), Health Impact Assessment (VIS), AND  INTEGRATED ENVIRONMENTAL AUTHORIZATION (AIA-IPPC).

Module 3

Definition of quality and its historical evolution.

Crosby, Deming, and Ishikawa

ISO ENI Uni standards and accreditation system

Quality management systems: ISO 9001

Environmental management system: ISO 14001:2015, an international benchmark for establishing, implementing, and improving an environmental management system.

EMAS (Eco-Management and Audit Scheme): A voluntary European system that allows companies and public bodies to evaluate and improve their environmental performance through an Environmental Management System (EMS) compliant with the ISO 14001 standard.

Healthcare product monitoring

The final exam will consist of a written test on the whole program.  The student can ask to integrate the test with an oral exam.