News

All the IT systems of the European Medicines Agency (EMA) will be temporarily unavailable from 6 am U.K. time on Saturday, April 16 to 6 am Sunday the 17th (U.K. time) due to essential maintenance, according to an EMA announcement released yesterday.

Applied Clinical Trials

For programs such as the Precision Medicine Initiative’s Cancer MoonShot to have a chance at success, following a set of key technology mandates will be critical.

This article focuses on the 3 essential factors that have a significant impact on the outcome of any inspection or audit. The author applies this primarily to GCP (Good Clinical Practice) inspections, but the principles are universal, being applicable to any government inspection such as the FDA (U.S. Food & Drug Administration) or industry QA (Quality Assurance) audit.