Description de la formation

Diploma of Advanced Studies (DAS) ist eine Nachdiplomausbildung der Hochschulen und entspricht mindestens 30 ECTS-Punkten.

The program offers continuing education to specialists in industry, hospitals and academia in the field of translational medicine and biomedical entrepreneurship, expertise highly needed in both industry and universities. Participants will acquire
the know-how to initiate and implement the translation process of products from the stage of development in industrial or research institutions to clinical applications with the goal of their commercialization. The focus is on both diagnostic and therapeutic medical devices and medicinal products.

Plan de la formation

The CAS Program consists of 3 out of 5 modules 1-5 plus module 6

• Module 1: Research and Development (4 ECTS)
  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)
  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)
  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)
  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)
  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)
  The development and commer cialization of a new biomedical product involves the coordina tion and leadership of a multidi sciplinary team. The module focuses on various aspects of entrepreneurship such as product management, business administration, and strategies to commercialize biomedical products.