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, Glossary and Table of Contents are currently available for use and download. You can view and download the publication “Negotiating your way through the vigilance agreement maze – is there a better way?” which addresses the landscape of Pharmacovigilance Agreements and outlines the integrated set of solutions developed to address the challenges. A webinar recording is available, which demonstrates how these solutions can help organizations improve their processes and achieve more efficient negotiations with their business partners.
Process Map
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.
Process Map
Check out the Interactive Process Map, complete with key considerations and tools.
Download and view this video, which explains how the Process Map can be used and provides some background on how it was created.
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.
These tools can also be accessed within the Interactive Process Map.
Digital Signatures for PV Agreements Tool
This tool offers:
- A summary of the potential advantages of using digital signatures
- A summary of the potential challenges companies might encounter with digital signatures and how to potentially overcome them
- Slides could be used to support partner discussions on adoption of digital signatures in territories where it is allowed by local legislation
Click here to download the tool or access it within the Interactive Process Map.
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.
Glossary
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.
The Glossary was updated in July 2022 to Version 2.0 to provide additional definitions, hyperlinks, cross-referenced related items, and an optimized alphabetical table.
Download now—Glossary. The Glossary can also be accessed here within the Interactive Process Map.
Download and view this video, which explains how the Glossary can be used and provides some background on how it was created.
Table of Contents
The TransCelerate PVA Table of Contents (TOC) offers a framework of modules, headings, points to consider, and regulatory references in relation to pharmacovigilance exchange of information and obligations between parties. This TOC was developed in the context of sponsor to sponsor, marketing authorization holder (MAH) to MAH, or sponsor to MAH and vice versa negotiations.
Similar to other documents, such as the Periodic Benefit Risk Evaluation Report (PBRER), where a regulation-based structure and content exists, we consider that this framework could offer efficiencies when managing PVAs throughout their lifecycle.
Download the PVA Table of Contents now.
The TOC framework is comprised of four modules:
- Module 1 – Background: Includes several sections which can be included in the Main Agreement and the PVA, or just in the Main Agreement. This module addresses the terms of agreement, legal sections, and administrative information. Therefore, this module may also relate specifically to the individual company guidelines and legal requirements.
- Module 2 – Pharmacovigilance Activities: Addresses the pharmacovigilance operational activities required for companies by legislation. It is not intended to be an exhaustive list, as the activities may depend on and be specific to the particular agreement and/or product.
- Module 3 – Cooperation and Support: Addresses the quality management system, compliance, record management, governance, business continuity, audits, and inspections.
- Module 4 – Appendices and Annexes: Addresses potential topics for appendices (if not addressed in one or more of the other modules).
Download and view this video, which explains how the Table of Contents can be used and provides some background on how it was created.
Timelines Benchmarking
The Timelines Benchmarking solution will be released in 2023.