Course Details

Preclinical studies and regulatory aspects

MS2145

Course
Preclinical studies and regulatory aspects
Code
MS2145
Academic Year
2026/2027
Curriculum Year
2025/2026
Degree Programme
MEDICAL BIOTECHNOLOGY
Curriculum
A010 - CELL THERAPY, TISSUE ENGINEERING AND REGENERATIVE MEDICINE
Course coordinator
Credits
9
Lecture Hours
54
Scientific Disciplinary Sector (SSD)
SECS-P/07 - Business Administration, BIO/17 - Histology, MED/04 - General Pathology
Course Type
Integrated learning activity
Course Delivery
OBB - Obbligatoria
Year
2
Teaching period
Primo Semestre
Campus
NOVARA
Teaching language
English
Course Contents
The primary objective of the course is to provide students with a broad yet comprehensive overview of: (1) "Biomaterials Immunomodulation" – how the immune system reacts to the presence of a biomaterial implant, and how such materials can be modified to mitigate the immune response; (2) "In vitro and in vivo Preclinical Models" – the advanced preclinical models available both in vitro (such as 3D spheroid cultures), and in vivo for the preclinical assessment of the immune response prior to implantation in a patient; and (3) "Technology Transfer and Regulatory Aspects" – the regulatory requirements and the academic and industrial steps involved in bringing a research product to an industrial scale.
Reference Texts
The slides presented during lectures contain data from scientific literature and provide sufficient material for preparing for the exam.
All slides are uploaded and made available to students on the DIR platform.
The full text of any article from which the data in the slides is drawn can be obtained upon request to the professor.
Learning Outcomes
The primary objectives of the course are to provide students with a comprehensive, 360-degree perspective on the preclinical validation of biomedical devices. This includes: (i) understanding the risks related to immune responses following the implantation of a biomedical device; (ii) adopting a sound experimental approach to the preclinical evaluation of biomaterials through appropriate in vitro and in vivo assays and models; and (iii) gaining knowledge of the regulatory and economic aspects that facilitate the funding, patenting, and industrial-scale production of biomedical devices.
Prerequisites
Basic knowledge of biology, biochemistry, anatomy, histology, immunology, physics, and mathematics.
Teaching Methods
Lectures are delivered using slides prepared by the instructor, based on research articles and literature reviews from the scientific literature.
All slides are uploaded and made available to students on the DIR platform.
The full text of all articles from which the data in the slides are drawn is available upon request to the professor.
Additional Information
Students with disabilities, Specific Learning Disorders (SLD), or Special Educational Needs (SEN) may request specific services and tools tailored to their needs by contacting the "Career Development and Coordination and Student Services" staff and by consulting the dedicated page on the University website: https://uniupo.it/it/servizi/servizistudentesse-e-studenti-condizione-di-disabilit%C3%A0-e-dsa. Once they have established contact with the University staff, students with disabilities, SLD, or SEN may reach out to the instructor of a given course to discuss the specific arrangements for examinations and other didactic aspects.
Assessment Methods
The examination consists of a multiple-choice quiz designed to assess the student's knowledge and understanding of the topics covered in class.
The exam is administered via the university's digital platform, Esami DIR.
Detailed Syllabus
For detailed syllabi, please refer to the individual module descriptions, which contain full course details.
Expected Learning Outcomes
By the end of the course, students will have gained an in-depth understanding of the mechanisms and key stages through which the immune system reacts to and attacks biomedical devices following implantation. At the same time, they will acquire advanced technical knowledge regarding the *in vitro* and *in vivo* assays and models that serve as benchmarks for the preclinical validation of biomaterials prior to clinical use. Finally, students will gain foundational knowledge of the economic models and regulatory aspects required to translate research outcomes into patents or secure funding, potentially leading to industrial application.

Moduli

Course year 2
Code MS2148
Course Technology transfer and regulatory aspects
Lecturers Mario VALLETTA
SSD SECS-P/07
Campus NOVARA
Curriculum CELL THERAPY, TISSUE ENGINEERING AND REGENERATIVE MEDICINE
Credits 3
Course year 2
Code MS2147
Course In vitro and in vivo Preclinical models
SSD BIO/17
Campus NOVARA
Curriculum CELL THERAPY, TISSUE ENGINEERING AND REGENERATIVE MEDICINE
Credits 3
Course year 2
Code MS2146
Course Biomaterials Immunomodulation
Lecturers Andrea COCHIS
SSD MED/04
Campus NOVARA
Curriculum CELL THERAPY, TISSUE ENGINEERING AND REGENERATIVE MEDICINE
Credits 3
Last update:21-10-2026 00:13:19