67133 - Regulatory environment and industrial production

Academic Year 2018/2019

  • Docente: Cristina Cavallari
  • Credits: 8
  • SSD: CHIM/09
  • Language: Italian
  • Moduli: Bruno Marchesini (Modulo 1) Lorenzo Autore (Modulo 2) Cristina Cavallari (Modulo 3)
  • Teaching Mode: Traditional lectures (Modulo 1) Traditional lectures (Modulo 2) Traditional lectures (Modulo 3)
  • Campus: Bologna
  • Corso: First cycle degree programme (L) in Applied Pharmaceutical Sciences (cod. 8518)

Course contents

PROGRAM MODULE I (dott. Bruno Marchesini)

ENVIRONMENTAL REGULATIONS After completing the course the student acquires sufficient knowledge on national legislation and EU environmental protection and human health. In particular legislation on chemicals, water, air emissions, solid waste, work environment

INTRODUCTION TO THE COURSE: THE ENVIRONMENTAL LAW
General principles of national and Community law.
The sources of Italian law.
EU sources.
Italian legislation.

SKILLS OF P.A.
The Ministry of the Environment.
ISPRA, ARPA APPA
Civil protection
The skills of the Region - Province - City environmental. WASTE MANAGEMENT Statement: D.Lgl.152 / 2006 and subsequent amendments
Waste categories
Packing

WEEE
Waste disposal, MUD and SISTRI

WATER POLLUTION
Rules on discharge. Statement: D.Lgl.152 / 2006 and subsequent amendments
Classification of discharges. Rainwater
Control of discharges and authorization system. AIR POLLUTION Statement: D.Lgl.152 / 2006 and subsequent amendments
The system of authorization, checks
Thermal plants
Air pollution, CO2 emission reduction

WATERS
Mineral water, water intended for human consumption
Swimming pools

ELECTROMAGNETISM Electromagnetic pollution.

NOISE POLLUTION Framework law on noise: Law 26 October 1995, n. 447.
D.P.C.M. of 14 November 1997: Determination of the limits of the sound sources.
The noise in the workplace.

THE ENVIRONMENTAL IMPACT ASSESSMENT (V.I.A.) EIA procedures, VAS, and integrated environmental authorization AIA

WORK ENVIRONMENT
D.Lgsl.81 / 08
Protection of health and safety in the workplace


PROGRAM MODULE II (dott. Lorenzo Autore)

REGULATIONS OF THE ENVIRONMENT AND INDUSTRIAL PRODUCTION

The sources of national (hierarchy) and European law (Directives, Regulations, Delegated Acts, Guidelines) - Definitions of: jurisprudence and doctrine - The three industrial revolutions - Because Europe generated the industrial revolution and Great Britain was first- fourth industrial revolution: Green Economy (the transition phase) - The "Green Paper" of the European Commission on integrated product policy

The Technical Standard (ISO, UNI, EN Standards) - Standard Codification - Introduction to Quality Management Systems ISO 9001, ISO 17025, HACCP and GMP (Good Manufacturing Practices).

The concept of product quality and safety in the industrial field, with particular reference to the safety assessment of cosmetic products and medical devices.

SCCS guidelines (Scientific Committee of Consumer Safety)

The ISO 10993 series on the evaluation of the biocompatibility of medical devices.

Technical and ethical issues related to the use of in vitro and in vivo tests to assess the risk to human health and the environment linked to the use of industrial products.

The program includes PC classroom exercises for research in databases of documentation related to topics covered.







Readings/Bibliography

MODULE I

Educational material distributed by the teacher during class.
Regulations available online
Text to refer to: Claudia Pasqualini Salsa - Environmental law - Maggioli Publisher

MODULE II

- Teaching materials: slides (campus) and the material distributed by the teacher.

 

Office hours

See the website of Cristina Cavallari

See the website of Bruno Marchesini

See the website of Lorenzo Autore