- Wissens. Assistent7in 70%, PhD, Management im Gesundheitswesen (de) (en)
- Wissens. Assistent/in 70%, Regulatory Affairs – Medizinprodukte (de) (en)
School for Translational and Entrepreneurial Medicine
Objective of the curriculum
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.
Organization and structure of the curriculum
The program is organized by the sitem AG in collaboration with Health Sciences eTraining (HSeT). Upon successful completion of the curriculum a Certificate of Advanced Studies (CAS), a Diploma of Advanced Studies (DAS) or a Master of Advanced Studies (MAS) is awarded by the University of Berne. The CAS and the DAS can be performed alongside the usual professional work (berufsbegleitend).
The MAS is a two-year lasting full-time program, consisting of a master thesis focusing on a real, practical translational project (80%) and theory (20%). The master thesis will be supervised and judged by a partner from a private-sector company and an academic clinician. The theoretical knowledge acquired during the 6 modules (see below) will be directly and specifically applied to the project, according to the “learning by doing” concept. In the master thesis presented at completion of the MAS, participants are expected to present a mature project from both a translational and entrepreneurial aspect.
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 (e-Training Portal).
A collection of quizzes on basics of biopharmacy, pharmaceutical technologies, medical technologies, OMICS technologies, biostatistics and epidemiology associated with online content to review the topics that need refreshing according to each individual’s needs.
Module 1: Research and development
This module reviews basic heuristic principles related to the discovery and development of diagnostic and therapeutic biomedical products.
Module 2: Quality management and good manufacturing practice
The focus of this module is the understanding of aspects essential to ensure that all activities linked with a translational process maintain the desired level of excellence required by the regulatory agencies.
Module 3: Intellectual property
Intellectual property rights given to investigators over the creations of their minds are essential for the successful commercialization of biomedical products. The different types of intellectual property and specific legal aspects for biomedical products will be discussed.
Module 4: Regulatory affairs
The role of the different regulatory authorities along the translational pathway and the product specific requirements for the various items will be analyzed.
Module 5: Clinical trial design and performance
Clinical trials are designed to test how well new medical approaches work in humans. The prerequisites for such scientific studies, the understanding of the pathophysiology of the underlying diseases and the definition of quantifiable endpoints by clinicians as well as the analyses of data by statisticians will be considered.
Module 6: Biomedical entrepreneurship and leadership
The development and commercialization of a new biomedical product involves the coordination and leadership of a large multidisciplinary team with a defined goal and scope. The module focuses on various aspects of entrepreneurship such as product management, business administration, and strategies to commercialize successfully biomedical products.
Why selecting this study program?
The teachers and supervisors in this program are from research and development oriented private companies, scientists from universities, ETHs and FHS, collaborators from regulatory agencies, financial experts or clinicians.
The program is approved by the University of Berne and therefore the prerequisites for admission are the same as for entering the University of Berne. As a corollary, the participants will be in a group of postgraduate students at a high academic level.
The study program (i.e. CAS, DAS or MAS) 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 master thesis can be performed in any institution (industries, universities, FHs, ETHs, hospitals).
The program is open for all academic disciplines. Academicians without a background in natural science, engineering or a medical discipline might of course need more time to accomplish the item “Prerequisites” (see above).
Most important, 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.
For further information please contact: Prof. Dr. med. Uyen Huynh-Do, director of postgraduate program ().
Die sitem-insel School Broschüre finden Sie hier.
Enabling Facilities: Translationsprojekte
Das Gebäude von sitem-insel AG wird ab 2019 bezugsbereit sein. Bis zu diesem Zeitpunkt werden alle Translationsprojekte in den Räumlichkeiten des Inselspitals durchgeführt werden. Für Informationen steht Ihnen Prof. Dr. med. Matthias Gugger, Direktor Lehre und Forschung des Inselspitals () zur Verfügung.
Die Promoting Agency ist im Aufbau begriffen und wird ab 2017 mit ihrer Arbeit beginnen. Für Informationen kontaktieren Sie bitte Prof. Dr. med., em. Felix Frey ().
Das Aktienkapital wird erweitert. Für Informationen kontaktieren Sie bitte Prof. Dr. med., em. Felix Frey ().