Pharmacovigilance Agreements Optimization

The Pharmacovigilance Agreements Optimization 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.

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 (PVAO) 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

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

Available Solutions

Coming soon:

  • 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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