Descrizione della formazione

The program aims at educating academic specialists in the field of translational medicine and entrepreneurship. Participants are expected to acquire the necessary skills to initiate and implement the process of transition of biomedical products from the stage of development in industrial or basic science institutions into clinical applications with the ultimate goal of their commercialization. The focus will be on both, diagnostic and therapeutic (medtech, pharmaceutical) products.

The study program will be taught by “blended learning”, what allows distance e-learning. This will be supplemented by concept lectures, peer learning and interactive discussions with specialists.

The MAS allows to perform investigations at the edge between medtech or pharmaceutical industry and university based clinical development. Specialists in that area are desperately needed in both, industry and university.

Piano di formazione

The curriculum consists of prerequisites and six independent modules of various sizes. All modules comprise case studies, quizzes, article based learning and concept lectures. A blended e-learning program is the structural base of the curriculum.

Prerequisites
The prerequisites section is organized as e-learning and offers participants the possibility to refresh their knowledge according to their individual needs, covering the basics of biopharmacy, pharmaceutical technologies, medical technologies, OMICS technologies and biostatistics and epidemiology.

Module 1: Research and Development (4 ECTS)
Module 1 revises basic principles related to the discovery and development of medical devices and medicinal products.

Module 2: Good Manufacturing Practice and Quality Management (5 ECTS)
This module focusses on how to ensure that all activities linked with a translational process maintain the desired level of excellence required by regulatory agencies.

Module 3: Intellectual Property (3 ECTS)
Module 3 is dedicated to different types of Intellectual Property and legal aspects that are crucial for the successful commercialization of medical devices and medicinal products.

Module 4: Regulatory Affairs (5 ECTS)
The Module focuses on the approval process for bringing innovative products to the market and describes the role of regulatory agencies, public and government agencies and notified bodies along the translational pathway.

Module 5: Clinical Trial Design and Performance (6 ECTS)
Module 5 considers key characteristics of clinical trial design and conduct. Participants learn about the prerequisites for such scientific studies, the importance of understanding the pathophysiology of the underlying diseases, the definition of quantifiable endpoints by clinicians as well as data management and statistics.

Module 6: Biomedical Entrepreneurship and Management (13 ECTS)
Module 6 concentrates on aspects of entrepreneurship with special focus on medicinal products and medical devices including leadership in multidisciplinary teams, project management, business administration and financial aspects that are needed for the successful commercialization of medical devices and medicinal products.

Master thesis (24 ECTS)