67133 - Regulatory environment and industrial production

Learning outcomes

At the end of the course the student has adequate knowledge of the national and community discipline on environmental protection and human health. In particular, regulations regarding chemicals, water, emissions to the environment of industrial origin or related to mobility, solid waste, electromagnetic and non-electromagnetic radiation. Furthermore, he knows notions regarding the main operations and equipment in use in industrial pharmaceutical and health production starting from the regulatory aspects up to the analysis of industrial and environmental risks.

Course contents

MODULE I PROGRAM (dott. Bruno Marchesini)

ENVIRONMENTAL REGULATION

Module 1 explores environmental legislation, focusing on the Italian and European Regulations related to this topic. Notably, the module offers an in-depth overview on the nature and management of substances used by industry that may produce dangerous emissions for air, water and soil and of  some physical risks for health connected to environmental conditions, such as noise and electromagnetic fields. As far as risk factors are concerned, module 1 presents various tools offered by law to manage these risks. These core topics are directly linked to the UN 2030 Agenda for sustainable development, with specific regard to: good health and well being (3); degradation of water resources (6 - clean water and sanitation); industrial innovation, green chemistry and circular economy (9 - industry, innovation and infrastructure); climate change (13 - climate action); degradation of the environment (15 - life on land).

UNIT 1:INTRODUCTION

The basis of the international law (general principles), Biodiversity, Sources of Italian and European law

The multilevel governance system for environmental protection:

Municipal, Regional and National Authorities,  Ministry of the Environment and Protection of Land and Sea, ISPRA, ANPA, ARPA and Civil Protection

UNIT 2:WATER POLICY AND MANAGEMENT

Mineral waters (LegislativeDecree 176/2011 - D.M. 11/09/2003 and 10/02/2015), water intended for human consumption (drinking water) (L.31/01) , swimming pools (Council Resolution of the Emilia Romagna Region n. 1092/2005), Wastewater discharges. Rainwater, Classification and treatment of discharges, Discharge permit and enforcement

Legislative Decree 152/06 (Environmental Protection Code)- Part III

UNIT 3: AIR EMISSIONS

Classification of air emissions, Greenhouse gas emissions policy. Solvent management plan (SMP), 

Emissions from thermal plants Air emission permit and enforcement

Legislative Decree 152/06 (Environmental Protection Code)- Part V

UNIT 4: WASTE

Categories and hazard classification of wastes. Handling and brockerage of wastes, Methods of waste disposal and principles of circular economy, Transportation of wastes, Waste permits and enforcement, Asbestos reclamation as a particular case

Legislative Decree 152/06 (Environmental Protection Code)- Part IV

UNIT 5: TRANSPORTATION OF DANGEROUS GOODS (ADR)

UNIT 6: WORKER PROTECTION

General requirements for health and safety at work,  Introduction to the duties of the main actors for the prevention of accidents and professional diseases, Chemical Risk Assessment

Legislative Decree 81/08 ((Title I-Part III and Title VIII-Part II)

UNIT 7: MAJOR ACCIDENT HAZARDS (The Seveso Directive)

UNIT 8: NOISE POLLUTION

Physical and psychophysical behavior of noise. Noise descriptors, Protection of workers from noise at the workplace

Law 447/95 Framework law on noise pollution

DPCM 14/11/1997 Determination of the limit values of the sound sources

Legislative Decree 81/08 (Title VIII-Part II)

UNIT 9:ELECTROMAGNETIC POLLUTION

Descriptors of EMF, Protection of workers from EMF at the workplace

Law 36/01 Framework law on EMF pollution

Legislative Decree 81/08 (Title VIII-Part IV)

UNIT 10: THE PERMIT SYSTEM

Environmental Impact Assessment (Valutazione di Impatto Ambientale) and Integrated Pollution and Prevention Control-Autorizzazione Integrata Ambientale), Strategical Environmental Assessment (Valutazione Ambientale Strategica), Environmental Single Permit (Autorizzazione Unica Ambientale)

Legislative Decree 152/06 (Environmental Protection Code)- Part II

 

MODULE II PROGRAM (dott. Leonardo Marchitto)

INDUSTRIAL PRODUCTION REGULATIONS

Harmonized European standards and product policy

The technical standard (ISO standard, UNI etc)

Quality management systems ISO 9001, ISO 17025, HACCP and GMP.

Quality and safety concepts of industrial products for pharmaceutical products: Monography Pharm. Eur. No. 2034 "Substance for Pharmaceutical Use". Organic impurities, genotoxic impurities, residual solvents, elemental impurities. API quality, EDMF (European Drug Master File), COS / CEP. Quality of the excipients used.

Concepts of quality, safety and biocompatibility of industrial products for medical devices and cosmetics

Quality and safety concepts of nutraceutical products

Readings/Bibliography

Module I
Didactic material distributed by the teacher during the lesson.
Regulations available online.

Compulsory reading:

B&P Avvocati "Guida all'ambiente-Analisi e commento del D.Lgs. 152/2006". Ambiente &Sicurezza"Novembre 2016. II Cap. I. Il testo unico ambientale dal 2006 ad oggi</ Cap. II. L'autorizzazione ambientale e la valutazione d'impatto ambientale Cap. III. La tutela delle acque e la gestione del servizio idrico Cap. IV. La gestione dei rifiuti Cap. VI. Le emissioni in atmosfera 

Optional reading:

V. Di Cataldo. A che cosa serve il diritto. Il Mulino 2017

Module II

Slides (campus) and material distributed by the teacher.

 

Teaching methods

Face to face classes /online with case studies discussions

Assessment methods

Oral examination

Methods of evaluation

The evaluation of the oral examination will be based on the following criteria: 1. knowledge of the course units; 2. appropriateness and coherence of the answer.

Students who demonstrate an in-depth knowledge of the course contents, logic and coherence in their answers, as well as an ability in problematizing notions, will obtain an excellent mark.

To obtain an average mark, students have to demonstrate a good knowledge of most contents of the course.

To obtain a pass mark, students have to demonstrate a basic knowledge of most contents of the course.

Teaching tools

Texts

Illustrative materials

Computer and video projector

Office hours

See the website of Bruno Marchesini

See the website of Leonardo Marchitto