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

A.Y. 2017/2018
8
Max ECTS
64
Overall hours
SSD
BIO/14 CHIM/09
Language
Italian
Learning objectives
Undefined
Expected learning outcomes
Undefined
Course syllabus and organization

Single session

Responsible
Lesson period
Second semester
Pharmaceutical Regulatory Affairs and Patents
Course syllabus
Procedures for obtaining the Marketing Authorisation. The Common Technical Document (CTD) and description of modules 3, 4 and 5. European public assessment reports (EPARs) and the Supplementary Protection Certificate (SPC). Biotechnological medicinal products. Biosimilars. Patents. Aspects of marketing and merchandising: medicinal products' supply chain. Healthcare issues. The price of medicinal products and pharmacoeconomic issues.
Biotechnological drugs: pharmaco-toxicological aspects
BIO/14 - PHARMACOLOGY - University credits: 4
Lessons: 32 hours
Professor: Corsini Alberto
Pharmaceutical Regulatory Affairs and Patents
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Lessons: 32 hours
Professor: Minghetti Paola