Rationale
The volume and complexity of PVAs continually increase year over year. Inefficiencies in negotiating and complying with PVAs wastes resources and contributes to non-value-added work due to:
- Ambiguous contractual terms and definitions can lead to non-compliance and increase the potential for audit and inspection findings.
- Lengthy negotiation periods & contractual maintenance discussions may lead to delays and potentially strained business relationships.
- Lack of awareness and data around operational timelines often used in PVAs can lead to negotiation inefficiencies.
- Complexity of PVA structures and content leads to challenges in review & negotiating terms.
The Pharmacovigilance Agreements Optimization Initiative focuses on addressing foundational elements related to PVAs, such as:
- The development, implementation, and maintenance of PVAs.
- Considerations for the table of contents and glossary.
- Benchmarking data of exchange timelines found in PVAs.
Importantly, this initiative does not seek to produce a standard industry PVA template nor provide recommendations pertaining to data exchange. Rather, this initiative seeks to produce a suite of customizable solutions for organizations, which could be used to support their end-to-end PVA process.
Benefits
- Reduce drafting and negotiation time, thereby potentially improving the timeliness and reducing the risk of delays to key milestones, such as clinical trial start, product launch, and asset transfer.
- Increase awareness of considerations that may impact PVA development.
- Serve as a resource for those involved in the end-to-end PVA process, including individuals newly engaging in PVA activities, or where a dedicated PV licensing function does not exist.
- Support improvement of accuracy and completeness of PVA, which may:
- Better support compliance to PVA and applicable regulations.
- Foster more comprehensive data exchange for PV activities, such as signaling and surveillance.
- Better support patient safety.
Available Solutions
The following solutions are now available:
- Process Map: An interactive tool that illustrates the end-to-end PVA lifecycle and key considerations throughout the development of PVAs.
- Glossary: Listing of definitions and synonyms often incorporated into PVAs. The Glossary was updated in July 2022 to Version 2.0.
- Table of Contents: A framework of headings and points to consider for potential incorporation into PVAs, including regulatory citations.
- Timelines Benchmarking: Aggregated benchmarking data of exchange timelines in member companies’ PVAs.
- Audit Process Efficiency: Marketing Partner audit scheduling, scoping, risk prioritization, conduct, response, and follow-up considerations.
