Implementing a process risk management system

This case study is focused on a project with an industry leading research based, top ten, pharmaceutical company.  The company is continuously striving to improve their operations and have embraced the regulators expectation of a more risk based approach to ensure they always focus on the areas of greatest impact and value.  With this ethos in mind, the company realised that there must be an opportunity to further enhance their PV operations through the application of risk management principles.  A particular area of risk was perceived to be the PV operations of local affiliates around the world.  Despite procedures and structures being in place to manage these operations, the central function could not be sure that the processes were being performed in alignment with their expectations.  Historically, the only insight into local operations was via internal audits or regulatory inspections.  However, it was deemed that these were too infrequent to ensure compliance.  Therefore, the implementation of a process risk management system was identified as an ideal solution to provide oversight of global PV operations.

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

Improving oversight and management of risks in your global pharmacovigilance operations.pdf