AIMS AND CONTENT

AIMS AND LEARNING OUTCOMES

The aim of these lessons is: to present the regulatory definition of biotechnological medicinal products; to provide a basic knowledge of the regulation governing the production, control, marketing and vigilance of these products, both for human and veterinary use, mainly at the European Community level, but also including references to the extra-EU legislation; to identify the regulatory bodies involved (Ministry of Health, ISS, AIFA at a national level; EMA, EDQM, OMS, ICH at an international level). Moreover, during the course, some industrial processes employed for the production of biotechnological medicines will be described.

At the end of the course, students will be able to describe the main regulatory aspects governing the biotechnological medicinal products, and will be able to describe some processes employed at the industrial level to produce this kind of products.

TEACHING METHODS

The course includes 8 hours of frontal lesson, with the support of the didactic material provided to the students through Aulaweb.

Any Student with documented Specific Learning Disorders (SLD), or with any special needs, shall reach out to the Lecturer(s) and to the dedicated SLD Representative in the Department (Prof. Luca Raiteri, Luca.Raiteri@unige.it) before class begins, in order to liaise and arrange the specific learning methods and ensure proper achievement of the learning aims and outcomes. VERY IMPORTANT: any request for compensatory tools and adaptations in the exam MUST be done within 10 working days before the date of the exam according to the instructions that can be found at https://unige.it/disabilita-dsa/comunicazioni.

SYLLABUS/CONTENT

• Definition of drug and of biotechnological drug
• European regulation for the production and marketing authorization of the biotechnological active substances and drugs, for human and veterinary use
• Biosimilars
• Main regulatory authorities and agencies involved: Ministry of Health, AIFA, ISS, EMA, EDQM, FDA, OMS, ICH
• References to pharmacoeconomics and pharmacovigilance
• Industrial processes for the production of some biotechnological medicinal products

RECOMMENDED READING/BIBLIOGRAPHY

The material used during the lessons will be provided on Aulaweb. For further detailed study, the following texts are recommended:

• Farmaci biotecnologici, aspetti farmacologici e clinici, E. Vegeto, A. Maggi, P. Minghetti, Casa Editrice Ambrosiana, 2020.
• Tecnologia Farmaceutica, a cura di P. Caliceti, Casa Editrice Ambrosiana, 2025.
• Legislazione farmaceutica, IX ed., P. Minghetti, Casa Editrice Ambrosiana, 2018 e relativi aggiornamenti.
• Legislazione farmaceutica nella pratica professionale, G. Barberini e L. Casettari L., Casa Editrice Piccin, 2021.

TEACHERS AND EXAM BOARD

LESSONS

LESSONS START

Visit the following webpage: https://corsi.unige.it/corsi/8451/studenti-orario

The timetable for this course can be found at: Portale EasyAcademy.

Class schedule

The timetable for this course is available here: Portale EasyAcademy

EXAMS

EXAM DESCRIPTION

The exam will consist of a written test with 3 open questions on the topics of all three 1 CFU modules (3 CFU total) lasting 1 hour and 30 minutes. To pass this test, the student must have obtained a passing grade in all three modules, otherwise he/she will have to repeat the entire written test. The written test can be taken only after having passed the 6 CFU immunology module.

ASSESSMENT METHODS

The exam evaluates the knowledge acquired during the lessons, according to the expected learning outcomes.

The evaluation parameters include:

• the competence within the subject;
• the ability to deal with the topics in a transversal manner;
• the quality of the exposition and the appropriate use of the specialized lexicon.

FURTHER INFORMATION

Contact the teacher for further information not included in the teaching sheet.