- Docente: Rafael Llorach Asuncion
- Credits: 6
- SSD: IUS/10
- Language: English
- Moduli: Carlos Molina Herrero (Modulo 1) Rafael Llorach Asuncion (Modulo 2) Helder Dias Mota Filipe (Modulo 3)
- Teaching Mode: Traditional lectures (Modulo 1) Traditional lectures (Modulo 2) Traditional lectures (Modulo 3)
- Campus: Bologna
- Corso: Second cycle degree programme (LM) in Chemical Innovation and Regulation (cod. 5701)
Learning outcomes
At the end of the course the student will be aware of chemical regulation and in particular with regulation in the food and pharmaceutical fields. The student will become familiar with the European REACH (Registration, Evaluation, Authorization and Restriction of Chemicals). A special focus will be put on substances having peciluar regulations like foods and pharmaceutial active substances. The student is expected to be able to: 1. comply with REACH regulation and with CLP labelling; 2. comply with the regulations concerning the use of chemicals in the food industry; 3. comply with regulations in the pharmaceutical industry
Course contents
This CU is composed of three modules:
(1) REACH and CLP
The course provides an overview of the remit of REACH and the increased responsibility it places on industry to manage chemical risks. The course introduces to the aims and core principles of REACH: protection of human health and the environment; enhance EU chemical industry competitiveness; and the promotion of alternative methods of dangerous substance assessment.
The Classification, Labelling and Packaging (CLP) Regulation (EC) No. 1272/2008, is another column of the Chemical Management Program in the European Union and provides the rules for the classification of hazardous compounds, their labelling, and Safety Data Sheet (SDS) information. The course provides an overview of this important regulation.
(2) Pharmaceutical Regulations
Therapeutic innovation. Role of regulations and regulatory authorities. Nonclinical development. Clinical development. Role of ethics. Regulatory process for medicines authorization. Medicines vs medical devices. Regulations on medical devices. Regulation of access. Health technology assessment (HTA). Development of generics and biosimilars and its role on access to medicines.
(3) Food Regulations
This module provides a comprehensive overview of the chemicals in food regulation
Readings/Bibliography
Slides will be available for students.
Teaching methods
The Course Unit is divided in three modules. Each module is organized in theoretical classes where main concepts are explained, as well as tutorial classes with discussion of case-study examples.
Assessment methods
Each module is assessed through a written assignment, or group assignment, or Individual report of a given problem related to the module content, or power point presentation of an assigned topic, including a report on literature research.
The Course Unit grade will be the arithmetic mean of grades from the three modules.
Office hours
See the website of Rafael Llorach Asuncion
See the website of Carlos Molina Herrero
See the website of Helder Dias Mota Filipe