The new ICH GCP E6(R2) addendum came into effect from June 14, 2017. The new addendum is the largest revision of the ICH GCP Guidelines over the past twenty years and it is fully supported by the European Medicines Agency (EMA). Previously, these guidelines were optional and the addendum now makes mandatory some activities related to Quality Management.
With the ICH GCP E6(R2) addendum, the sponsor is required to implement a system to manage quality throughout all stages of the trial process. Through a risk-based approach, the assurance of quality should be proportionate to the risk inherent in the trial and the importance of the information collected. The Sponsor should focus on trial activities essential to ensuring human subject protection and the reliability of trial results.
This week, seQure Life Sciences would like to present the impact introduced on Quality Management:
To download our infographic, click here.