CODE 108670 ACADEMIC YEAR 2024/2025 CREDITS 1 cfu anno 4 CHIMICA E TECNOLOGIA FARMACEUTICHE 8451 (LM-13) - GENOVA 1 cfu anno 3 CHIMICA E TECNOLOGIA FARMACEUTICHE 8451 (LM-13) - GENOVA 1 cfu anno 4 FARMACIA 8452 (LM-13) - GENOVA 1 cfu anno 5 FARMACIA 8452 (LM-13) - GENOVA SCIENTIFIC DISCIPLINARY SECTOR CHIM/09 TEACHING LOCATION GENOVA SEMESTER 2° Semester MODULES Questo insegnamento è un modulo di: OPTIONAL SUBJECTS TEACHING MATERIALS AULAWEB AIMS AND CONTENT AIMS AND LEARNING OUTCOMES Medical devices are, together with medicines, a fundamental tool to ensure the current efficacy of the medical treatments. Their use in the diagnostic, therapy and rehabilitation fields is essential, and this justifies the development of this world market and its distinctive and strong technological innovativeness. The knowledge of the medical device definition and classification, together with the knowledge of the rules regulating their production, control, marketing and surveillance, represents an important basis for Pharmacy and CTF graduates, who can look towards this area as an interesting occupational field. The aim of these lessons is: to present the regulatory classification of medical devices; to provide a basic knowledge of the rules regulating the production, control, marketing and surveillance of medical devices, differentiated on the basis of the risk class; to mention some aspects related to the national regulation (CND classification). At the end of the course, the student should possess the fundamental knowledge of the definition and classification of medical devices and of IVD medical devices, and of the related rules regulating their production and marketing. TEACHING METHODS The course includes 8 hours of frontal lesson, with the support of the didactic material provided to the students through Aulaweb.The course includes 8 hours of frontal lesson, with the support of the didactic material provided to the students through Aulaweb.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 medical device Regulatory classification of medical devices Technical and regulatory aspects regulating the production and marketing of medical devices and IVD medical devices RECOMMENDED READING/BIBLIOGRAPHY The attendance to the lessons and the material provided on Aulaweb are sufficient to prepare the final exam. For further detailed-study, the recommended texts are the following: Regulation (EU) 2017/745 Regulation (EU) 2017/746 TEACHERS AND EXAM BOARD GIORGIA AILUNO Ricevimento: The teacher receives the students by appointment agreed through the institutional mail address available on the University website. LESSONS Class schedule The timetable for this course is available here: Portale EasyAcademy EXAMS EXAM DESCRIPTION The exam involves passing a written test composed of multiple-choice questions. ASSESSMENT METHODS The exam evaluates the knowledge of the regulatory classification of medical devices and of the main rules regulating their production and marketing.
