Discover the program and the teaching modules covered during the postgraduate course. Download the dedicated brochure here where you can consult all the main information and the detailed program.
Training
Module
The postgraduate course in Integrated Management of Medical Technologies Regulatory Affairs is the Level II University Master’s degree of 12 months which will allow young graduates and healthcare professionals and beyond to analyze the developments taking place in the medical devices sector, in particular concerning the regulatory and healthcare management world. The course will train specialized figures who will be able to guide researchers and companies in the process of placing medical devices on the market in full compliance with regulations.
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BASIC MODULE
Module I aims to provide specific knowledge and competences (medical, engineering, legal, economic, design skills) on the most innovative and applicative aspects of medical devices. The module aims to develop multidisciplinary skills in the medical, legal, scientific, technological, economic and industrial design sector in order to characterize, manage and develop solutions for an integrated approach to the development, certification and marketing of medical devices.
- Teaching methodology: lectures, exercises, laboratories, seminars, individual study
- Profit check: not present
MODULE II
HOURS: 500
ECTS: 20
ADVANCED MODULE
Module II is divided into 9 Advanced Training Courses (CAFs) focused on emerging and innovative aspects related to the development and marketing of medical devices. Not only are the Advanced Training Courses aimed at students of the postgraduate course, but they are also accessible to first level graduates, Master’s degree graduates and graduates from systems prior to the Ministerial Decree 509/99. The courses will take into consideration various aspects (legal, engineering, medical aspects, as well as methodological and integrated management):
– Esperto di ricerca clinica su dispositivi medici
– Regole dei mercati e tutela dell’innovazione giuridica
– Network Medicine: una nuova visione della medicina
– Tecnologie robotiche e digitali in ambito medico: sicurezza e aspetti regolatori
– Tecnologie ICT per i dispositivi medici
– Scelte economiche per il settore sanitario nell’ambito della responsabilità sociale
– Human Centred Design per i Dispositivi Medici: dall’Usabilità all’Ergonomia Cognitiva
- Attendance: participants will be able to choose the Advanced Training Courses according to their preferences but they need to achieve at least 20 required credits. They can also follow all 9 Advanced Training Courses proposed (equal to 61 ECTS). The Advanced Training Courses are organized in such a way that there is no overlap with each other.
- Teaching methodology: Lectures, Exercises, Laboratories, Seminars, Individual study (only the practical part, where planned, is carried out in person)
- Profit verification: intermediate tests and any tests aimed at achieving the qualification of Clinical Research Expert on Medical Devices are foreseen.
MODULE III
HOURS: 375
ECTS: 15
INTERNSHIP
Module III is focused on “Know How” and it consists of activities tailored to projects for the evaluation and integrated management of medical devices for medical devices manufacturing companies, notified bodies, competent authorities and regulatory agencies, as well as research and development centers that deal with innovation in the medical devices sector.
- Teaching methodology: Lectures, Exercises, Seminars, Training internships
- Profit verification: a final evaluation at Sapienza University of Rome is planned, Confindustria Dispositivi Medici and partner organizations of the postgraduate course.
ADDITIONAL ACTIVITIES
HOURS: 125
ECTS: 5
INSIGHTS
The postgraduate course includes the participation in seminars, conferences, in-depth workshops on specific innovative topics on the management of medical devices and the world of regulation and Advanced Training Courses (in addition to the credits provided for Module II) as a part of the educational offer.
FINAL EVALUATION
HOURS: 125
ECTS: 5
ACHIEVEMENT OF THE TITLE
The Final Evaluation, which is necessary in order to achieve the title, consists in the elaboration and discussion of a technical-experimental thesis on the integrated management of Medical Devices. The final paper will be presented by the candidate in front of the Board of Examiners.