With ICH GCP E6 (R2) the emphasis is on Quality Management

Guest Blogger Andrew Milroy – HRPP and CQA Manager (Merita CQA) For 19 years ICH GCP E6 has not changed. Now, nearly two decades after its initial release, change is coming. Perhaps the biggest difference is the focus and preeminence of Quality Management. A modernized quality standard for clinical study processes is being espoused which […]