Biotechnological drugs: pharmaco-toxicological aspects and Pharmaceutical Regulatory Affairs and Patents

A.Y. 2020/2021
8
Max ECTS
64
Overall hours
SSD
BIO/14 CHIM/09
Language
Italian
Learning objectives
The purpose of the course is to introduce the students to the pharmacology (pharmacokinetics, toxicity and pharmacodynamics), the relevant European Community legislation concerning Marketing Authorization (MA) and patents of new biotechnological medicinal products, including biosimilars.
Expected learning outcomes
The student will acquire the knowledges needed to understand how monoclonal antibodies (and biosimilars) work, how they can be used in the treatment of several pathologies, how to evaluate their toxicological profile and the legislative aspects and patents.
Course syllabus and organization

Unique edition

Responsible
Lesson period
Second semester
Biotechnological drugs: pharmaco-toxicological aspects
BIO/14 - PHARMACOLOGY - University credits: 4
Lessons: 32 hours
Professor: Bellosta Stefano
Pharmaceutical Regulatory Affairs and Patents
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Lessons: 32 hours
Professor: Minghetti Paola
Professor(s)
Reception:
Please, write an email to schedule an appointment
Office, first floor at the Department of Pharmacological and Biomolecular Sciences, via Balzaretti 9, Milan