Key Resources

Rationale

The number of pharmacovigilance agreements (PVAs) are continually increasing. Inefficiencies in negotiating and complying with PVAs wastes resources and contributes to non-value adding work due to: ​

  • Ambiguous contractual terms and definitions​
  • Lengthy negotiation periods​
  • Lack of awareness and data around operational timelines commonly used in PVAs​
  • Various placements of structure and content​
  • Lengthy contractual maintenance discussions​

​The Pharmacovigilance Agreements Optimization Initiative focuses on addressing foundational elements related to PVAs, such as the process for developing PVAs, considerations for the table of contents/glossary, and benchmarking of exchange timelines. 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 customizable, interactive resource for new and experienced contract partners, which could be used to inform and/or streamline their PVA process development, contract drafting, and negotiations.

Benefits

  • Reduce the time spent on drafting and negotiation of PVAs, e.g. may facilitate earlier clinical trial start
  • Increase awareness of applicable regulations that impact PVA development
  • Improve accuracy, completeness, and timeliness of PVA and compliance with regulations
  • Increase understanding of general considerations for PVA development
  • Serve as a resource for entities newly engaging in PVA activities, or where a dedicated PV organization doesn’t exist

Available Assets

  • Process Map: An online tool outlining steps in development of PVAs
  • Glossary: Model definitions and synonyms for use in PVAs
  • High-level Table of Contents: An outline of model headings commonly used in PVAs
  • Benchmarks for PVA Exchange Timelines: Aggregated benchmarking data of exchange timelines specified in PVAs

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