Course Unit R-U1 Chemical Regulation
Course Unit R-U2 Food and Drugs Regulations
Course Unit R-U3 Regulation and Nanotech
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.
- Teacher: Carlos Molina
Course Unit R-U1 Chemical Regulation
This module provides a comprehensive overview of the chemical control framework in US, Japan, Brazil and China and other countries and regions. It covers current regulations concerning hazardous chemical substances and their production, import, and use, as well as some essential hazard communication requirements including the GHS-based labelling and SDS requirements implemented by these countries- Teacher: Daniel Sainz
Course Unit R-U2 Food and Drugs Regulations
Course Unit R-U3 Regulation and Nanotech
To introduce the regulatory aspects of the drug development process in Europe.
To introduce the regulatory aspects of other health products development.
To discuss the importance of pharmaceutical innovation and the regulatory mechanisms to support innovation.
To discuss the difference between access to market and access to patients.
- Teacher: Helder Mota Filipe
Course Unit R-U3 Regulation and Nanotech
To introduce principles of nanoparticles synthesis characterization and application
To introduce principles of nanotoxicology
To introduce frameworks of risk assessment/management/ governmental legislations
To show how safe and sustainable by design nanomanufacturing can be implementedCourse Unit R-U1 Chemical Regulation
- Teacher: Irene Belincion
Course Unit R-U2 Food and Drugs
Regulations
- Teacher: Rafael Llorach