Beschreibung des Angebots

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

This study program is designed to train professionals in scientific and medical knowledge, and simultaneously in entrepreneurship skills to enable them to successfully coordinate the development and commercialization of biomedical products. 

The CAS Program consists of 5 modules (23 ECTS) and the DAS thesis (4 ECTS).

• 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.