We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » EMA Clarifies ‘Triggers’ for Routine, For-Cause GCP Inspections
EMA Clarifies ‘Triggers’ for Routine, For-Cause GCP Inspections
August 22, 2013
As drug sponsors make their way through the EU approval process, there are certain “triggers” that should help European Medicines Agency (EMA) inspection coordinators determine whether a clinical trial should undergo a routine or for-cause good clinical practice (GCP) inspection, such as trial size, complexity and site selection, an agency working group says in a new report.