To promote Good Clinical Practice (GCP), the International Conference of Harmonization ICH-E2C (R2) requires all license holders of new medicinal products to submit a Periodic Benefit-Risk Evaluation Report (PBRER). This challenging document is a cyclical assessment of the product’s benefit-risk balance to the applicable licensing authority.

When developing a PBRER, authors should be wary of the limited production time. The breadth and complexity of data must be rapidly sourced and checked across numerous functions during this period. The first PBRER is often the most challenging to produce and has a higher likelihood of close examination due to health authority inspections of a new license holder’s pharmacovigilance reporting system. In extreme circumstances, a poorly produced PBRER may even contribute to the triggering of such an inspection and further scrutiny of a license holder’s pharmacovigilance process.

To mitigate these issues, our whitepaper outlines best practices that can be implemented during the process of creating an initial PBRER, with advice regarding:

• International product birth dates
• ICH guidelines and ICH GCP
• Safety systems
• Patient exposure and support
• Submission portals
• Periodic Safety Update Report (PSUR) in pharmacovigilance