Introduction to the Quality Management System for Combination Products

Open to all EKFZ-associated members

Speakers

Fenja Hanneken, Mohamad Mersalli, Dr. Adrian Flierl (Quality Management & Regulatory Affairs Team, EKFZ-OT)

Description

• The EKFZ Academy workshop “Introduction to the Quality Management System for Combination Products” will guide through the processes and procedures required to introduce and implement a quality management system (QMS) in a startup or spin-off out of an academic setting. The workshop will cover the quality requirements for both gene therapies as well as medical devices from conception to implementation. In this context, the challenges and synergies for combining different regulatory requirements with the structures within academic institutions will be outlined. Finally, the critical and important processes and procedures for quality management will be introduced in context of their institutional setting.