Re-engineering adverse event processes

In early 1995, Zeneca Pharmaceuticals decided to re-engineer its flailing adverse event process.  This was to become one of the most rigorous and effective applications of business process re-engineering to safety reporting procedures undertaken in the pharmaceutical industry.

Within Zeneca Pharmaceuticals, the Product Safety Group (PSG) is responsible for ensuring that safety data are collected and entered into the company's international database.  In addition to the consequent and on-going evaluation of the safety profile of each medicinal product, PSG must produce information allowing Zeneca to meet regulatory requirements for the notification of suspected adverse drug reactions (ADRs) on an international basis.  By early 1995, this procedure was showing signs of strain.

To read this case study in full, please click on the pdf link below:

Redefining the safety reporting system.pdf