Key take-aways from our June Webinar on modernizing your PVAs. Insights from presenters Katherine Long and Kevin Fetterman on streamlining your PV Agreement process from versioning through implementation with total oversight throughout.
A robust Pharmacovigilance Agreement can protect both sides of a business partnership from uncertainty, communication gaps, and compliance risks. In fact, the GVP modules require these agreements to ensure QPPV oversight, even including a list of partnerships in the PSMF. Yet, despite the advantages of the PVA, the complex and varied arrangements among each pharmacovigilance agreement can increase the burden of work and compliance risks for your organization. Due to largely manual oversight processes, demonstrating compliance to all PV agreements is an increasing challenge for MAHs/Sponsors.
Colleagues Katherine Long and Kevin Fetterman spoke on behalf of the Orbit team on modernizing your business’ approach to PVAs. The main aim of the webinar was to lay out the complexities with:
- PVA versions and approvals
- Implementation of activities across contributors
- Oversight of global status
Using a technology platform like Orbit can manage these challenges. Orbit is a platform that helps to streamline this process by providing a central repository for all information related to the PVA, including the contract, responsibilities, and timelines. It also has a feature called Active Compliance Monitoring, which sends out automatic notifications to confirm that all tasks are being met. This can be extremely helpful in keeping track of progress and ensuring that everything is on track.
Managing Versions and Approvals
Having a means of managing the every action per contributor enables PVA managers and other team members to proactively assess and address these steps throughout this cumbersome process. The steps alone seem straightforward, but as the various parts are acted upon, the actions, versions, and approvals compound and require a continuous back and forth throughout the lifecycle of the PVA. For companies with many partners and vendors, managing the workload around pharmacovigilance agreements is complex, the fundamental steps quickly become overwhelming. Having a system in place that facilitates notifications, tasks, deadlines, communications across partners, products, and countries start to become essential in maintaining compliance. Moreover, the snapshot reporting easily showcases that in addition to the results of – what actions are being done, when are they completed, and by whom?
Orbit serves as a single repository displaying total traceability into all actions from development through retirement. Within that, Orbit has two use-cases: (1) manage documents and templates in the system, or (2) allow users to link outside the system to other document management systems such as SharePoint through an external link. We find that the first option is a preferred method as it becomes the central repository for all the contributing pieces, eliminating the need to go in and out of the system whatsoever.
Active compliance monitoring for executed PV Agreements
As Katherine emphasized, the exciting piece is making your process work best for you. Orbit streamlines its process with a centralized database housing all the information related to that PVA — the contracts, responsibilities, and timelines — all in a highly accessible way. Once the agreement clauses are agreed upon and in place, a user needs to execute on those activities with a history of: where is the information? which terms apply to which activities? who should be contacted? This Active Compliance Monitoring sends out automatic notifications to confirm that all tasks are met, metrics are captured, and all progress is made across the agreements and simultaneously meeting regulatory demands. As you can see the challenge is more than getting the document completed; the oversight is quite complicated with all its moving parts, making the Active Compliance Monitoring necessary to see the historical overview across the lifecycle of the business partnership.
The benefits of a system are clear within PVAs. Having tasks and notifications automatically sent out internally and externally keep all contributors current of who is doing what by when. These insights can then be used to improve your process and readily see which partners and/or processes tend to be more challenging or potentially pose an additional compliance risk. Proactively staying on top of tasks not only prevents CAPAs and keeps your compliance status in check, but your teams can work collaboratively in a single place, without having to track down the work or the people doing the work.