The Pharmacovigilance Agreements Optimization (PVAO) Initiative is focused on developing solutions and accompanying tools to address challenges across the lifecycle of pharmacovigilance agreements (PVAs). With the increasing volume and complexity of PVAs, the need for simplification and efficiency is greater than ever. Our suite of solutions is designed to be adaptable and flexible to support diverse PVA stakeholder needs and improve efficiencies.
From our suite, the Process Map and Glossary are currently available for use and download. Coming soon in 2022, the Table of Contents and Timelines Benchmarking will be available.
The Process Map solution illustrates the end-to-end PVA lifecycle and offers key considerations throughout the development and maintenance of PVAs. In addition, there are several sets of tools available to address key bottleneck areas within the lifecycle, e.g., negotiation. Overall, the Process Map facilitates understanding of the PVA development and maintenance process and provides practical guidance for direct or indirect cross-functional stakeholders.
Check out the Interactive Process Map, complete with key considerations and tools.
Download now — Process Map (PDF Version)
PROCESS MAP TOOLS
Pre-PVA Involvement of Pharmacovigilance (PV) Function
This tool is a customizable presentation for functions responsible for creating PVAs who engage with internal stakeholders managing business collaborations and is designed to help them understand the need for PV involvement. The presentation focuses on the benefits of involving PV early in the process and supports fostering efficient relationships between functions. Click here to download the tool or access it within the Interactive Process Map.
Systematic Approach to PVA Negotiations
Below are a set of tools that offer an optional framework for PVA managers to help enhance the efficiency of PVA negotiations through a project management approach. See the specific tools below.
- Five Steps for Efficient Negotiation—This graphic illustrates a concept of how to gain efficiency in PVA negotiation in five steps.
- Kick-off Agenda—A presentation slide deck that can be used to plan and facilitate a kick-off meeting with negotiation stakeholders before drafting a PVA.
- Gantt Chart—Provides a project plan template to help manage PVA negotiation timelines between the PVA partners.
Periodic PVA Review: Checklist & Documentation
This document can be used to help determine whether a PVA may need to be updated during a periodic review. It also provides space for documenting the periodic review and any required subsequent actions. Click here to download the tool or access it within the Interactive Process Map.
To assist with the PVA process, the Glossary contains a listing of key definitions and synonyms often incorporated into PVAs. The Glossary also includes an “Addendum” that provides additional contextual information for the key definitions, including regional definitions, e.g., EU, USA. This solution can help stakeholders operate more efficiently through all phases across the PVA lifecycle by supporting a common understanding of key terminology and definitions.
Table of Contents
The Table of Contents solution will be released in 2022.
The Timelines Benchmarking solution will be released in 2022.
Communicating with Stakeholders
Additional tools coming soon.
Publications are targeted to be available in 2022.
A full list of regulatory references will be available in 2022.