Enhancing PVA Template Updates for Quality, Compliance, and Patient Safety
Featured Solution: Table of Contents
A sponsor company used the Pharmacovigilance Agreements Optimization “Table of Contents” solution in the following ways:
Updating an internal PVA template to improve quality and compliance
The company was conducting an annual review of its pharmacovigilance agreements (PVAs) and leveraged the “Table of Contents” (TOC) to improve the quality of the template. When a section within the PVA template came up for review, the PVA lead worked with the business owner to suggest an update based on the TOC. Furthermore, the PVA lead utilized the tool as an example for the various sections as the business owner drafted their suggested edits. These updates improved the quality of about three different PVA templates. The updates are expected to impact about 50 partner agreements a year. These revisions promote greater compliance and help with business relationships through the PVA negotiation process.
Training new team members faster
The TOC is a resource for new hires and existing PVA team members responsible for a new template. The TOC served as an example that team members could reference and ensure consistency in the onboarding and education of teams. Using the TOC helps bring higher quality work sooner from new hires and existing team members with new responsibilities.
Helping key stakeholders complete their sections with greater quality
Sometimes internal team members who need to provide input to a PVA have minimal experience interacting with other companies. For example, PVA leads utilized the TOC to help global safety officers (GSOs) who had varying experiences interacting with other companies in the PVA process. GSOs referenced the TOC to understand better what elements were reasonable and appropriate to include in a PVA with a partner. This helped GSOs check that the correct content was referenced in the agreement, improving quality, and ensuring patient safety.
In all the uses, the TOC facilitated more efficient communication, review, and internal harmonization. Overall, this improved the quality of the PVAs and the likelihood of compliance. Since PVAs underpin safety monitoring, this ensures patients are better protected and improves patient safety.
