ICH Q9 (R1) – What is new and how to navigate it

ICH Q9 established a framework for QRM with the intention of introducing QRM approaches that could be leveraged by both the industry and regulators. However, it has been observed that the full potential of QRM has not been reached, which is the reason why the council decided on issuing a revision. The new themes serve as areas of improvement that can facilitate the implementation of QRM.

In this webinar we will highlight the key principles of the guideline, investigate the core QRM process and focus on the updates of this latest revision (R1)