Biotechnological drugs: pharmaco-toxicological aspects and Pharmaceutical Regulatory Affairs and Patents
A.Y. 2018/2019
Learning objectives
Undefined
Expected learning outcomes
Undefined
Lesson period: Second semester (In case of multiple editions, please check the period, as it may vary)
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
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
Professor(s)