Acquire knowledge on the classification, production and controls of Medicinal Products for Advanced Therapies
Course Prerequisites
Basic knowledge on pharmaceutical technologies
Teaching Methods
Lecture; Gruop work Practical exercises Not provided.
"For students with specific needs, who are unable to attend educational activities in person and who have applied for Inclusive Educational Methods, appropriate study materials will be made available for effective self-study. If requested, self-learning can be supported by tutoring activities or supplementary teaching, and by dedicated meetings, including online ones, with flexible scheduling according to the students' needs."
Assessment Methods
The exam consists of a written report on an ATMP product on the market to be presented together with an oral presentation (with ppt).
The dates of exams will be published on the DDS website.
Texts
Teaching material presented during the lessons (constituting the topics of the exam) will be available in pdf format on Kiro platform
Contents
Introductory concepts related to advanced therapy products and regenerative medicine. Regulatory framework. What are Advanced Therapies (AT), how they are used, and their classification. Gene therapy products - how gene therapy functions and its administration. Viral vectors and Adeno-Associated Viral vectors. Production of Viral Vectors, development of safe and effective Viral Vectors. Approved gene therapies in Italy. CRISPR & Genomic Editing. Cellular therapy products - Stem cells: what they are, characteristics, and types of stem cells. Embryonic stem cells, adult stem cells. Authorized cellular and tissue therapies in Europe. Case study I: Holoclar, Case study II: Renutend, and Case study III: Arti Cell Forte. Tissue engineering products - 3D structure vs Sophisticated Matrix, tissue engineering approaches, 3D scaffolds, case studies. Combined advanced therapy products - case studies.
Course Language
Italian
More information
All teaching materials are uploaded to the Kiro platform
