Beschreibung des Angebots

Diploma of Advanced Studies (DAS) is a postgraduate qualification awarded by universities and corresponds to at least 30 ECTS credits.

The program offers career specialized training in Advanced Regulatory Affairs with particular focus on the European Medical Device Regulations. It addresses graduates interested in commencing a career in the regulation or of medical devices and also targets those from complementary disciplines such as entrepreneurship, research and development, and management, seeking comprehensive and practical knowledge in this field.

Aufbau der Ausbildung

The modular structure of the continuing education programme in Regulatory Affairs and Quality Management allows students to pursue their goals in a way that best suits their needs. Each CAS corresponds to at least 15 ECTS credits, which are earned by completing at least three modules.

Modules to choose from:

CAS Regulatory Affairs:
Module 1: Introduction Regulatory Affairs
Module 2: Pre-Submission Regulatory Affairs
Module 3: Post-Submission Regulatory Affairs

CAS Advanced Regulatory Affairs:
Module 1: Foreign Regulatory Affairs
Module 2: Combination Products
Module 3: Digital Health Technologies and Security
Module 4: Research and Development
Module 5: Clinical Trial Design and Performance