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).
Agenda:
- Introduction QRM
- ICH Q9 principles and General QRM Process
- Special Points to consider
- Major Changes ICH Q9 (R1)
- QnA and Discussion
Do you want to be part of this informative webinar? Don´t hesitate to sign up here: Webinar: ICH Q9 (R1) – What is new and how to navigate it by GxP-CC Webinars (bigmarker.com).
Do you have more questions about this topic? Contact us