Pharmacovigilance Agreements Optimization

The Pharmacovigilance Agreements Optimization (PVAO) Initiative seeks to produce a suite of customizable solutions for organizations, whether new or experienced in the pharmacovigilance agreement (PVA) process, which could be used to inform and/or streamline their end-to-end PVA process.

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 key definitions and synonyms often incorporated into PVAs.
  • Table of Contents: A framework of headings and points to consider for potential incorporation into PVAs, including regulatory citations.

The following solutions are coming soon in 2023:

  • Benchmarks for PVA Exchange Timelines: Aggregated benchmarking data of exchange timelines in member companies’ PVAs.

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