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

A.Y. 2019/2020
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
Prerequisites for admission
Students are required to attend and pass the exam of Pharmacology and Pharmacotherapy before attending the present course.
Assessment methods and Criteria
Students will prepare and present orally research (by groups of 2-4 students, PowerPoint file) on one of the drugs presented during the lessons, covering all the different points of view: pharmacology, toxicology, therapeutics, legislation, and pharmaceutical technique.
Pharmaco-toxicology of biotechnological drugs
Course syllabus
Biotechnological drugs
Pharmaco-toxicology of biotechnological drugs
Erythropoiesis stimulating agents
Monoclonal antibodies used in autoimmune diseases
Anti-inflammatory monoclonal antibodies
Monoclonal antibodies in oncology
Teaching methods
Oral lessons
Teaching Resources
Lessons slides and additional material available on ARIEL website.
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)
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.
Teaching methods
Oral lessons
Teaching Resources
Lessons slides and additional material available on ARIEL website.
Pharmaceutical Regulatory Affairs and Patents
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Lessons: 32 hours
Professor: Minghetti Paola
Pharmaco-toxicology of biotechnological drugs
BIO/14 - PHARMACOLOGY - University credits: 4
Lessons: 32 hours
Professor: Bellosta Stefano
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