Our first step was identifying an LCPPV for each country, screening candidates with a qualification process. After preauditing potential LPPVs, we gave them a questionnaire and evaluated their curriculum vitae. Candidates’ quality management systems, pharmacovigilance systems, experience, and expertise also came under our scrutiny. It was no easy task...especially as we had to repeat this process for 50 different countries. After a kickoff meeting, we introduced the LPPVs to a PV manual we created exclusively for their support and provided training. With detailed chapters on local regulations and requirements, this manual empowered our LPPVs with instructions on what, how, and where to report safety information.
Our client’s local PV system also included literature screening. After preparing a list of periodicals for the drug portfolio, we partnered with vendors who scanned journals in the local languages. If the screening detected new safety information or adverse events, our client would quickly receive a report.
Local ICSR case processing was another way we helped our client mitigate risk. Each country received access to the PV safety mailbox. We then would compile important ICSR findings in a monthly report for our client to follow up on.
But our local PV services would not have been complete without regulatory intelligence once the project went live. Our vendors compiled information for a monthly report to keep our client up to date. If the information was urgent, our vendor would alert our client within one business day.