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 you through the processes and procedures required to introduce and implement a quality management system (QMS) in a startup or spin-off from an academic environment. The workshop will cover the quality requirements for both gene therapies and medical devices, from conception to implementation. In this context, the challenges and synergies of combining different regulatory requirements with the structures within academic institutions will be outlined. Finally, the critical and key quality management processes and procedures will be introduced in the context of their institutional setting.