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

A.Y. 2021/2022
Overall hours
BIO/14 CHIM/09
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

Single session

Lesson period
Second semester
Specific information on the delivery modes of training activities for the academic year 2021-2022 will be provided over the coming months, based on the evolution of the public health situation.
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 (by groups of 2-4 students, PowerPoint file) research on one of the monoclonal antibodies, choosing among those presented during the lessons or chosen among those in clinical use, covering all the different topics: pharmacology, toxicology, therapeutics, legislation, and pharmaceutical technique.
The final grade will cover also the section on Normativa relativa all'AIC ed ai brevetti dei medicinali.
Biotechnological drugs: pharmaco-toxicological aspects
Course syllabus
Biotechnological drugs
Pharmaco-toxicology of biotechnological drugs
Monoclonal antibodies used in autoimmune diseases
Anti-inflammatory monoclonal antibodies
Monoclonal antibodies in oncology
Monoclonal antibodies against angiogenesis
Use and safety of monoclonal antibodies
Teaching methods
Oral lessons. If necessary, lessons will be via Teams.
Teaching Resources
All the slides presented at the course and the recording of the lessons will be published on the 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.
Aspects of marketing and merchandising: medicinal products' supply chain.
Healthcare issues. The price of medicinal products and pharmacoeconomic issues.
Teaching methods
Oral lessons. If necessary, lessons will be via Teams.
Teaching Resources
Lessons slides and additional material available on ARIEL website.
Biotechnological drugs: pharmaco-toxicological aspects
BIO/14 - PHARMACOLOGY - University credits: 4
Lessons: 32 hours
Professor: Bellosta Stefano
Pharmaceutical Regulatory Affairs and Patents
Lessons: 32 hours
Professor: Minghetti Paola
Please, send an email to schedule an appointment
Office, second floor at the Department of Pharmacological and Biomolecular Sciences, via Balzaretti 9, Milan