Tagged with: EU

Post Authorization Safety Studies (PASS)

Studies performed after a product has been placed on the market is called Post Authorization Studies and those that have a primary safety objective is called Post Authorization Safety Studies. This is the general definition but very specific meanings can be associated with these terms in individual countries and regions like the US or the European Union...

Drug Safety Introduction

Costs of illness due to adverse effects of drugs is estimated to 117.4 billion ($ 117.400.000.000) in 2000 for the United States alone (Ernest and Grizze, 2001). It is hard to comprehend the magnitude of this number, but it is only the financial side of the problem. It is estimated that up 98.000 American die every year due to drug related events an unknown number of patients experience additional suffering and injuries (2).

Inspection Checklist

The drug safety function needs to be continuously ready for inspections by the authorities. A wide range of items have to be considered and documented before an inspection. The details are described in this article.

Quality Management System

A formal Quality Management System (QMS) is now being expected for a drug safety function in the pharmaceutical industry. The QMS focus on the organizations ability to ensure stable processes which are continuously monitored and improved.