Advanced Workshop: QPPV Tool Box – Your Key to Success

This session will discuss how the QPPV can supervise and be involved in establishing the safety governance processes for signal detection and benefit-risk assessment, be responsible for the adequacy of documentation describing these processes and their tracking and assure compliance. The QPPV is expected to explain best signal detection practices, the rationale for different methodologies and choice of sources for signal detection and how validation should occur.