Importance of a PVA
A Pharmacovigilance Agreement’s importance boils down to the shared activities between two or more parties, which is defined in this legal document between the Marketing Authorization Holder (MAH) and a third party. The purpose of the agreement is for the MAH to access all the relevant information relating to PV activities shared between the partners. This contract is a living document and maintaining compliance of these shared activities becomes quite the all-encompassing challenge. GVP Module I provides a nominal outline plus additional considerations, but there is no definitive standard in how to carry out the scope of the document– the format, timelines, exchange of cases and information, reports, approvals, submissions, and the like, all which require detailed and timely considerations when delegating who is doing what by when.
In these agreements, the ownership is multi-directional and often collaborated throughout many functional areas. Simply having an overview of who is doing what, by when, and where, is a time-consuming process, especially if not properly tasked and managed. Without a centralized location or document exchange, companies risk missed commitments, loss of productivity, and inability to demonstrate compliance during inspections and audits.
Three Major Lifecycles
1. Negotiate & Draft is the first phase in identifying the who, what, when, and where.
2. Active Compliance Monitoring is the second and perhaps most difficult phase to oversee all actions and track progress as it takes shape holistically. The review of workflows, lifecycle transitions, and identification of trends, are all captured, up-to-date, and searchable.
3. Contract Retirement is the final phase resulting in up-versioning of the PVA or complete termination and retirement. It houses the ability to compares versions over time, provides evidence of all the work, and demonstrates compliance.
The Five Phases of a PVA
The ability for all stakeholders to enter key data, track lifecycle statuses, and use document templates to capture all the details and standardize the workflows throughout the lifecycle of the agreement guides your review cycles for all stakeholders both internally and externally, ensuring compliance throughout this matrixed process.
Active Compliance Monitoring
Maintaining and demonstrating compliance is the most important and most difficult aspect of the PVA. The communications, processes, and responsibilities increase in complexity when all these actions are difficult to trace for oversight. Using a tracking system and following a template with the five phases laid out is a means to streamline this process and alleviate much of the manual back and forth.
Active compliance monitoring is the ability to check each activity and make sure you’re being compliant in all areas of the PVA. For example: in literature we found this number of cases, here’s what we received, what did we miss? what did we not miss? That snapshot of compliance is how an organization can address areas for risk or point to areas/partners that are compliant and areas that are not.
Another overlooked piece is the communication gaps among the processes and systems used. Nobody likes to micromanage, but all parties want to detail the clear split of responsibilities and oversee those continuous actions with the hand-offs, acknowledgement, and approvals. This proactive oversight ensures complete traceability so as not to miss deadlines or fall out of compliance.
Lastly, searching through contracts can be a challenge when agreements are not stored in a central database or repository. Instant access to your information is important, with the ability to then access snapshot reporting across all your markets, products, and partners.
The Orbit Approach
The goal is to keep this process simple by automating mundane tasks that kick off actions that are directly sent out to their respective stakeholders. These agreements become quite complex when left to manual check-ins and multiple persons initiating and coordinating those actions or acknowledgements. If a process can be simplified, maintaining these agreements will alleviate some of the pains with managing the PVA. The ideal is to have quality agreements that leverage templates with streamlined processes that are easy and accessible to update for all invested partners.
Having insights into your data can only improve your process while readily capturing which partners and steps tend to be more challenging, and potentially pose risks. The proactive monitoring keeps your compliance status in check, allowing your internal and external teams to work collaboratively in a single setting, which is the biggest burden of this process, the collaborative process. The benefits of a system are clear within PVAs, how confident are you in your organization’s process?
Reach out to us workinorbit.com to learn more about how to simplify your PVA Management.