In our recent webinar, Automation in PV Agreement Tracking, Feith’s in-house subject matter expert, Michelle Peralta, gave an overview of PV Agreement landscape and the legal & regulatory impetus behind structured and automated tools. We’re reviewing some of her key points here.
A PVA (also referred to as Safety Data Exchange Agreement, or SDEA) is a contractual document between two parties, generally a Marketing Authorization Holder and a third-party. A PVA will describe the shared or contracted activities and arrangements affecting pharmacovigilance (PV).
A PVA is commonly drawn up as part of a Master Commercial or Development contract. As made clear in GVP Module I, even when activities are delegated or subcontracted, the sole responsibility for meeting PV regulations remains with the MAH.
When a MAH subcontracts or delegates PV responsibilities to a business partner or contractor, then those responsibilities, as well as oversight mechanisms, must be clearly defined in a PVA.
This includes common contents for any contract, like the type and scope of agreement, terms and provisions, and key information about parties involved in the contract. Common types of PVA include in-licensing, out-licensing, co-marketing, and co-development, but MAH’s may opt to contract out many more activities like local QPPV, local MAH, signal detection and management, risk management and ISCR processing, among many others. These negotiated PV activities must be clearly defined, as do the mechanisms to ensure that these activities are being completed regularly and with high-quality.
The successful handling of PVA obligations is a critical but often overlooked consideration.
PVA’s call for frequent and repetitive tasks that need to be performed manually, including:
- Regular reconciliation of ICSR exchange between the parties’ safety databases
- Recurring oversight of delegated activities
- Distribution of safety communications and reports to relevant partners
Given the large volume and wide variety of PVA’s, performing these tasks is complex. Unstructured and passive storage mechanisms can leave business partners puzzled over their exact responsibilities, how to comply with their PVA obligations, when obligations are applicable and who is responsible.
In these challenges, there lies great opportunity moving toward an active and automated approach.
Your team’s success can be enabled and sustained by the right tools, through structure and automation. This will ensure compliance with legal and regulatory obligations while fostering harmonious business relationships.
To learn more about Orbit’s solutions for PVA’s, you can access the webinar recording here.