Regulatory Aspects in Toxicology

The course will focus on the regulatory and legislative aspects related to the manufacturing and marketing of health products. The course will provide students with a complete overview of the relevant guidelines and standardised methods to evaluate biocompatibility of medical devices and the toxicological assessment of chemical, biocidal and pharmaceutical products. It will also outline the steps required for the manufacturing and placing on the market of medicinal products (biotechnological products and radiopharmaceuticals in particular), cosmetic products and food supplements.The course will focus on the regulatory and legislative aspects related to the manufacturing and marketing of health products. The course will provide students with a complete overview of the relevant guidelines and standardised methods to evaluate biocompatibility of medical devices and the toxicological assessment of chemical, biocidal and pharmaceutical products. It will also outline the steps required for the manufacturing and placing on the market of medicinal products (biotechnological products and radiopharmaceuticals in particular), cosmetic products and food supplements.

At the end of the course the student should
· understand the classification of health products;
· understand what defines biotechnological and advanced therapy medicinal products, medical devices and biocidal products and what are their specific requirements;
· be able to outline in broad terms the steps required to place a medicinal product on the market in the EU;
· understand the requirements of EU regulation for medical devices;
· understand the EU regulation for chemicals and biocidal products;
· be able to navigate OECD Guidelines for the Testing of Chemicals, in particular Section 4 "Health Effect";
· be able to retrieve and understand the relevant parts of EU legislative acts.